june 5 - 11, 2014 corporate cipla to expand ... 5 - 11, 2014 corporate cipla to expand global...

June 5 - 11, 2014

CORPORATE

CIPLA TO EXPAND GLOBAL FOOTPRINT THROUGH INVESTMENT OF £100 MN IN ITS UK

SUBSIDIARY

Pharmabiz, 7 July, 2014

Cipla, a Rs.9,000 crore plus Indian pharma giant, has decided to invest up to £100 million in its UK

subsidiary over the next few years in collaboration with the UK Government. George Osborne, Chancellor

of the Exchequer, Her Majesty’s Government of the United Kingdom said, “I am happy to be able to

announce that Indian pharmaceutical company Cipla will invest up to £100 million in the UK. The

investment will fund the launch of a range of drugs in the areas of respiratory, oncology and antiretroviral

medicines as well as research and development, clinical trials and further expansion internationally and in

the UK. Cipla is one of India's leading pharmaceutical firms and this decision shows the UK's international

strength and attractiveness in this sector as well as its growing importance in Cipla’s long term strategy"

said the Chancellor.

LUPIN TO SET UP TWO NEW R&D CENTRES IN US

Economic Times, 6 July, 2014

Pharma major LupinBSE -2.00 % said it is in the process of setting up two new R&D centres in the US,

focusing on research in inhalation and on complex formulations. "In keeping with our global strategy of

building a highly differentiated generic and speciality business, the company is in the process to setting up

two dedicated Centres of Excellence for research in inhalation and complex injectables in Florida and

Maryland in the US," Lupin chairman Desh Bandhu Gupta said in its annual report. The company had also

increased research and development spending to Rs 958.28 crore in FY'14 as compared to Rs 770.85 crore

in the FY'13. "Lupin continues to invest heavily in its R&D programmes and in FY 2014, the company

invested 8.6 per cent of its net sales in R&D and related spends, amounting to Rs 958.30 crore," Gupta said.

It had invested 8.1 per cent of its net sales in R&D and related spends amounting to Rs 770.85 crore in

FY'13. Research is the backbone of our performance. In addition to a robust internal generics research

programme, 2013-14 marked significant enhancement of our research capabilities, Lupin Managing

Director Nilesh Gupta said. The company said that in 2013-14, it had stepped up its filings made by the

process and formulations research group. FY 2014 also marked making progress in its Novel Drug

Discovery and Development (NDDD) and Biotechnology research programmes. Gupta said: "Our generics

research programmes continue to fuel the company's growth into higher orbits of leadership in advanced as

well as emerging markets.

DRL FACES SUIT IN US COURT

Financial Express, 10 July, 2014

California-based Roche Palo Alto and Switzerland-based Helsinn Healthcare havefiledasuitagainstDr

Reddy's Laboratories with a complaint in a New Jersey federal court, alleging that the generic-drug maker's

proposed version of the anti-nausea drug Aloxi would infringe one of their patents. Roche and Helsinn both

claim a new drug application and an abbreviated new drug application filed by Dr. Reddy's with the US

FDA seeking approval to manufacture and market a generic version of Aloxi, used via intravenous

injection, would infringe one of their patents.

LUPIN, UNICHEM AMONG SIX GLOBAL FIRMS FINED BY EUROPEAN COMMISSION


Indian drug firms Lupin and Unichem Labs are among six global drugmakers on which the European

regulator has imposed a collective fine of 427.7 million euros for striking deals to prevent entry of the

cheaper version of blood pressure drug Per indopr il in the EU. According to the European Commission's

Anti-trust ruling, Lupinhasbeenfined40mil-lion euros (nearly Rs 325 crore), while Unichem Labs has been

fined 13.96 million euros (over Rs llO crore). The companies have been pulledup for striking a series of

deals with French firm Servier, which used to sell patented perindopril drug, so that cheaper copies of the

drug are not launched in the EU. Besides Servier, the other drug makers on whom the European

Commission has imposed fines totaling 427.7 million euros are Matrix (nowpart of Mylan), Teva and Krka.

"Through technology acquisition and a series of patent settlements with generic rivals, Servier implemented

a strategy to exclude competitors and delay the entry of cheaper generic medicine to the detriment of public

budgets and patients inbreachofEU antitrust rules," European Commission said in a statement.

ABBOTT IN PINK OF HEALTH, VALUATION REMAINS BIG PULL


Abbott India, the listed Indian subsidiary of Abbott Labs, USA, holds a very promising prospect among

multinational drug companies in India. The company enjoys strong brand equity in multiple therapeutic

categories, including women's health, gas-troenterology neurology, thyroid, diabetes, pain management,

vitamins and anti-infectives, with seven of its top ten brands commanding leadership positions in their

respective categories. Its RS 100-crore flagship brand Thyronorm (for treating thyroid disorder) has a

47.5% market share while Brufen is its highest-selling pain-relief drug with a 97.8% market share. The

recent re-launch of its 70-year old anta-acid brand Digene commands a market share of 18 % and is going

to further boost its market share. For the 15-month period ending March 2014, the company has

outperformed the Indian pharmaceutical market, with its core business growing 14.1% when the market

grew 10.1% over the previous year. The company's revenues have grown at a compounded annual growth

rate (CAGR) of 28% to RS 2,345 crore in the last five years while the net profit has grown similarly at 26%

to RS 198.45 crore during the same period. Abbott is a debt-free company with a return on net worth of 25

%. The acquisition of Piramal Healthcare's domestic formulations business by its parent in 2010 remains a

separate unlisted business. With the easing of trade disruptions following the implementation of the new

drug pricing policy, the domestic pharma market is likely to recover this fiscal. According to Hitesh Ma-

hida of Antique Stock Broking, the domestic market should return to its historical growth of 14-15% in

FY15 on account of a low base and price increase allowed this year on products under price control. This

recovery will benefit companies like Abbott with a strong presence in this market.

UNICHEM LABS TO APPEAL EUROPEAN COMMISSION DECISION


Unichem Laboratories has decided to appeal the European Commission decision in EU court of imposing a

wholly unjustified fine on Nice/Unichem (jointly and severally)contending that it had acted in breach of EU

Antitrust Rules. The European Commission reached this conclusion because its subsidiary, Niche Generics

Ltd (Niche), agreed to settle financially crippling patent litigation with Laboratories Servier (Servier) at the

beginning of 2005. Unichem vehemently denies any wrongdoing on the part of either itself or Niche.

Moreover, Unichem was not involved in the agreement to settle the litigation with Servier back in 2005 as it

only took full ownership of Niche late in 2006. Unichem cannot in any way see how it can be held

accountable for what was in any event a pro-competitive act on the part of its then only part-owned

subsidiary Niche. Unichem will vigorously appeal the European Commission decision to the EU courts and

seek to attain the correct result in this matter a result which is in the best interests of the consumer. While

Unichem presses ahead with its intention to have the European Commission’s decision overturned it intends

to carry on its business as usual.

SUN-RANBAXY DEAL BOOSTS DOMESTIC M&A

News Today, 5 July, 2014

The mergers and acquisition (M&A) activity involving domestic companies jumped 21.9 percent at $20.5

billion in the first half of 2014 over the same period last year, says a report. 'The value of announced M&A

deals involving companies reached $20.5 billion during the first half of 2014 despite a 11.2 percent

slowdown in the number of deals from 582 to 517', a report by Thomson Reuters said on Thursday. The

average M&A deal size climbed to $95 million during the reporting period from $62.8 million the same

period last year. Domestic M&As stood at $10.1 billion, up 295.9 per cent compared to the first half of

2013. 'This was driven by Sun Pharmaceutical's pending acquisition of Ranbaxy Labs for $4 billion in a

stock swap transaction. The deal pushed the healthcare sector to capture 39.6 percent of the domestic deal

making', the report said.

GLENMARK PHARMA SEEKS FOREIGN PARTNERS ON BIOLOGIC DRUGS


India's Glenmark Pharmaceuticals Ltd is in talks with foreign companies for a partnership on two of its

biological drugs being tested for the treatment of chronic pain and autoimmune disorders, a senior executive

said on Thursday. Glenmark is looking for companies whose research pipelines would complement its

experimental drugs, GBR830 and GBR900, which are both in phase 1, or early stage clinical trials on

humans, Chairman and Managing Director Glenn Saldanha said. He declined to give names, but said he

expects to find partners by the time the two drugs complete phase 2 clinical trials, which will be "anywhere

from a year to two years." "It will depend on whether the companies are therapeutically focused on that area

and whether they have a conflicting molecule in their pipeline," Saldanha said in an interview at Glenmark's

headquarters in Mumbai. While India's $15 billion pharmaceutical industry is mainly engaged in the

development and sale of generic medicines, Glenmark is among the few that continue to invest in the

development of original medicines.

SUN PHARMA SUBSIDIARY RECALLS SOME LOTS OF ANTIDEPRESSANT DRUG

VENLAFAXINE HYDROCHLORIDE FROM US MARKET

Economic Times, 10 July, 2014 Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma, has initiated recall of some lots of

Venlafaxine Hydrochloride extended-release tablets from the US market. According to a notification by the

FDA, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles is voluntarily

initiated by the company through a letter to the regulator last month under 'Class-II' classification.

Venlafaxine Hydrochloride extended-release tablets are indicated for the treatment of major depressive

disorder. "Stability results found the product did not meet the drug release dissolution specifications," the

regulator's website said. Tablet dissolution is a standardised method for measuring the rate of drug release

from a dosage form. The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories Ltd

in USA, while manufactured at Halol plant in Gujarat by Sun Pharmaceutical Industries Ltd. According to

the US health regulator, Class II recall is a situation in which the use of or exposure to a violative product

may cause temporary or medically reversible adverse health consequences or where the probability of

serious adverse health consequences is remote.

DR REDDY'S TO REBRAND FOR INTERNATIONAL APPEAL

Deccan Chronicle, 5 July, 2014

A year after the demise of its founder K. Anji Reddy, India's second largest drug maker Dr Reddy

Laboratories Ltd is all set to launch a massive rebranding exercise, which include changing its logo

among others, to position itself as a global generic player, with greater research focus. "Dr Reddy's is

planning to rebrand itself by changing its logo and reposition itself as a global drug maker with an expanded

footprint," said a person, who .;..„ had intimate-. knowledge about the rebranding plans. The Hyderabad-

based pharmaceutical major, which would be celebrating its 30th anniversary next February, is expected

hire prominent branding experts to implement the plan. When contacted, a company official first wanted to

know the source of information, and later said that the company could offer no comment. But after an hour,

the official called up to say that the company was denying the story "This is the first time that a

pharmaceutical company in India is planning to rebrand itself. Though it may not have any impact on its

core business, it will certainly help in improving its communication," Sarabjit Kaur Nangra, who tracks

pharmaceutical companies at Angel Broking, told this correspondent. Dr Reddy's has come a long way from

being a producer of APIs in 1984 to one of the strong players in global generics.

HSI INDIA CONDEMNS GOVT'S PLAN TO OPEN NEW ANIMAL FACILITY IN CHENNAI


Concerned by the plans to build what is touted to be India’s largest housing facility for animals used in

laboratory experiments in Chennai, Humane Society International/India strongly criticised and condemned

the move. Alokparna Sengupta, deputy director of HSI/India stressed that it is deeply regrettable that even

in the 21st century, India’s scientific community remains stuck in its old ideas of building animal research

facilities. He said that testing pharmaceuticals and drugs on animals is notoriously poor-quality science,

with the United States Federal Drug Administration acknowledging that nine out of every 10 drugs

appearing safe or effective in animals will go on to fail in humans. “Around the world these tests are being

surpassed by state-of-the-art non-animal methods that are far better able to predict responses in people.

Instead of wasting valuable funds on last century’s science, India should be investing in these cutting-edge

alternatives, joining nations such as the United States, South Korea and the United Kingdom in building

centers for non-animal research and better science,” he pointed out. HSI/India, whose Be Cruelty-Free

campaign played a central role in advancing India’s policy to ban animal testing for cosmetics, also is

working with government and research institutions to promote non-animal methods for biomedical research

and safety testing. Animal based research is fraught with uncertainty because biological and physiological

differences between mice, rats, dogs and people can produce dangerously misleading results and delay

medical progress.

STOP STEP-MOTHERLY TREATMENT OF PHARMA SECTOR IN INDIA: CIPLA


Hailing the British government's efforts in encouraging research and development in the pharmaceutical

industry, Cipla chairman Yusuf Hamied has said the "step-motherly" treatment given to this sector in India

has to stop. In the wake of the company's announcement in India of plans to invest 100 million pounds in its

British subsidiary alongside the UK government, Hamied appealed to the Indian government to also do

more in the field. "This is something we Indians can take a lesson from the British as to how the British

government here is encouraging us to come and do research with the benefits that they are giving us,"

Hamied said at a reception at the India House here last evening in recognition of his honorary degree

conferred by Cambridge University recently. "By and large the step-motherly treatment that we have got

over the years has to stop and we have to be encouraged to do more," he said. UK Chancellor George

Osborne had yesterday announced Cipla's UK investment plans during his ongoing visit to India. The funds

are aimed at the launch of a range of drugs in the areas of respiratory, oncology and anti-retroviral

segments. Hamied expressed hope that the new Indian government would also take strong action over the

issue of monopolies in the healthcare sector. "I have been fighting with our Indian government that we

should have a system so that there is no monopoly in healthcare; it is about saving lives and cannot be

regarded totally as a business. There has to be a humanitarian approach to healthcare," the leading scientist

and philanthropist said.

RELIV OPENS CENTRE IN BENGALURU TO OFFER SPECIALISED RELIEF FOR CANCER

AND OTHER RELATED PAIN


The Reliv, a comprehensive pain management centre and a specialised facility for management of chronic

cancer pain, has opened its first centre in Bengaluru. The facility is equipped with state-of-the-art medical

equipment to deal with chronic pain, including back pain, neck pain, joint pain, cancer pain, headaches,

neuropathy, and other unique pain conditions such as reflex sympathetic dystrophy. The facility is managed

by a team of experienced and qualified physicians. “India has a high prevalence of chronic pain. People

continue to suffer from debilitating pain for years without realising that effective technologies now exist

beyond physical therapy and simple creams and ointments that can give them significant relief. The Reliv

Pain Centre now offers the latest treatment facilities for effective and safe management of all types of

chronic and intractable pain in any part of the body,” said Dr. Madhu Yelameli, founder director, Reliv Pain

Centre. The doctors at the Reliv are trained in the US and UK on the use of state-of-the-art technology and

devices for managing pain arising due to any condition. According to Dr BS Ajai Kumar, founder &

chairman, HCG Group of Hospitals who was at the inauguration of the facility, there are many diseases like

cancer where patients require a care to manage constant pain. In fact, pain management is an essential part

of their recuperation.

ABLE KICKS OFF FIRST OF BIRAC SERIES TO MOULD YOUNG BIO-ENTREPRENEURS

WITH UNIVERSITY OF RAJASTHAN


The Association of Biotechnology Led Enterprises (ABLE) is now engaged with the Center for Converging

Technologies (CCT), University of Rajasthan to inspire future entrepreneurs. The initiative is the first of the

Biotechnology Industry Research Assistance Council (BIRAC) supported series on ‘Stimulating Bio-

Entrepreneurs’. The key objective of the programme is to motivate the dynamic skilled and self-confident

young student community to instil concepts to build new ventures and support them. BIRAC also

encouraged the students to apply for the ongoing call of its flagship scheme: Biotechnology Ignition Grant

(BIG), which supports innovative ideas with grant-in-aid amount up to Rs. 50 lakh. According to Dr Renu

Swarup, Advisor, DBT & MD, BIRAC, “the aim of the series is to spark an entrepreneurial interest in

young minds and the selected universities will provide an ideal setting. After the first series of 8 talks in 4

university clusters, the programme will be rolled out in several others.” Lead coordinator Dr K

Vijayaraghavan from Sathguru Management Consultants, discussed with the students the, ‘Roadmap to

entrepreneurship’ and encouraged them to develop a global perspective and utilize the Indian ecosystem to

adopt Life Sciences as their domain to create enterprises. He also mentioned the value creation in any

innovative idea.”

INTERNATIONAL

SKULDTECH CHANGES NAME TO ACOBIOM


Skuldtech, an expert in the discovery of genomic and transcriptomic biomarkers and specialized in the

development of innovative diagnostics, changes its name to Acobiom. The new name is intended to confirm

the company’s strategic shift towards personalized medicine, which started in 2009 and represents a major

opportunity for the medicine of the future. Personalized medicine tailors treatment to the patient’s

biological characteristics. It is one of the most promising approaches in oncology and in the targeted

treatment of neurodegenerative diseases and some infections. Used in screening, diagnosis and in

evaluating response to, or tolerance of, a targeted therapy, biomarkers are increasingly linked to the

development and growth of the market for personalized medicine. According to PwC, the current value of

the US market for personalized medicine is USD 232 billion (EUR 170 billion). The therapeutics and

diagnostics segment is expected to reach USD 42 billion by 2015, with average growth of 10 per cent per

year. In taking the name Acobiom, the company seeks to promote and develop its companion diagnostics

and its expertise in the discovery of new biomarkers. It also embodies their strong position within ‘omics’

technologies. In the coming months Acobiom plans to bring new companion diagnostics to market and to

launch new clinical trials for cancer. Acobiom has filed two cancer-related patents and is expected to file a

further two in the same thematic area by the end of the year.

METROPOLIS HEALTHCARE INTRODUCES PLAC TEST TO DETECT CARDIOVASCULAR

DISEASES


Metropolis Healthcare, one of the leading multinational chain of diagnostic centers, will offer PLAC test, a

risk stratification test which identifies the enzyme in the blood vessels. PLAC test is a simple blood test that

measures the enzyme activity of Lp-PLA2 level in the body. It is a cardiovascular-specific inflammatory

marker implicated in the formation of rupture-prone plaque. Lipoprotein-associated phospholipase A2 (Lp-

PLA2) is a blood vessel enzyme, found to be the second most predictive of heart attack risk, also warns of

vulnerable plaque that could erupt like a volcano. The higher the level of Lp-PLA2, the higher the risk of

CV events i.e., heart attack and stroke - even with normal LDL cholesterol. Lp-PLA2 as a biomarker for

cardiovascular risk stratification has been endorsed by various guidelines published by the American

College of Cardiology Foundation/America Heart Association, the American Stroke Association, the

American Association of clinical endocrinologists in 2010, 2011 and 2012. “PLAC test is a simple blood

test that assesses your cardiac health. Cholesterol testing alone is not enough; as a traditional cholesterol

test can miss hidden risks for heart attack.

UCB, DERMIRA COLLABORATE TO DEVELOP CERTOLIZUMAB PEGOL FOR PSORIASIS


UCB, a leading biopharmaceutical player and Dermira, a privately held US-based dermatology company,

entered into an exclusive licensing agreement for the development and future commercialisation of Cimzia

(certolizumab pegol) in dermatology. This collaboration aims to broaden patient access to Cimzia and make

it available to patients with psoriasis, a chronic autoimmune disorder. . Cimzia is not currently approved for

the treatment of psoriasis by any regulatory authority. . Under the terms of the agreement, UCB grants

Dermira an exclusive license to develop certolizumab pegol for psoriasis in the US, Canada and the

European Union. Dermira will be responsible for phase III development costs and will receive payments of

up to $49.5 million on the achievement of development and regulatory milestones. . Subject to regulatory

approval of Cimzia in psoriasis, Dermira is granted an exclusive commercial license to market Cimzia to

dermatologists in the US and Canada. UCB will record the sales and Dermira will receive tiered royalty

payments on those product sales which are attributable to dermatologists in the US and Canada and up to

$40 million upon the achievement of tiered commercial milestones. In support of the partnership, UCB has

made a $5 million equity investment in Dermira and a commitment to invest up to an additional $15 million

in future Dermira equity financings.

NOVARTIS INTRODUCES NEW ANTI-MALARIAL FORMULATION, COARTEM 80/480 IN

KENYA


Novartis has launched a new high quality antimalarial formulation of Coartem 80/480

(artemether/lumefantrine 80 mg/480 mg), for the treatment of uncomplicated malaria in adults and older

children who weigh above 35kg. The drug has been registered by the Pharmacy and poisons board in

Kenya, has already been launched in Nigeria and Angola. Kenya is the 3rd country in Africa to launch

Coartem 80/480. Other countries that have registered Coartem 80/480 include Uganda and Ghana. In a bid

to enhance patient compliance, the full course of treatment for malaria has been reduced from 24 tablets to

six tablets translating into a 75% reduction in pill burden. On this day, Novartis joins the people of Kenya

and the rest of Africa, in celebrating a great achievement in the fight against malaria. According to Dr.

Nathan Mulure, the Novartis Medical Manager for Africa, Malaria is highly preventable and curable, yet it

is still one of the most deadly diseases in developing countries. “Novartis reaffirms its strong commitment

to the fight against malaria. This achievement is a truly remarkable milestone contributing to treating many

patients and help in the reduction of disease burden. The fewer tablets offer a convenient solution for busy

lives. “The launch of Coartem 80/480 in Kenya marks another milestone in the fight against Malaria, and

will benefit patients with a convenient and high quality treatment for malaria,” he said. The Coartem 80/480

was first registered in Switzerland by a stringent health authority, the Swiss Medic. Novartis pioneered the

launch of a fixed-dose ACT, and ten years later, in 2009, the first dispersible ACT was tailored to meet the

needs of children who are the most vulnerable to malaria. “Through a partnership with the World Health

Organization (WHO) in 2001, we were the first company in the healthcare industry to commit to the supply

of antimalarial treatments to the public sector in endemic countries without profit”, added Dr Nathan

Mulure. Since 2006, Kenya has received over 75 million treatments of Coartem. Kenya is thus one of the

largest recipients of Coartem. Each year there are more than one million malaria-related deaths around the

world. Nine out of ten malaria deaths occur in sub Saharan Africa, and the vast majority of malaria-related

deaths occur in children.

WATERS & CHINESE PHARMACOPEIA COMMISSION INK LABORATORY COOPERATION

PACT, TO OPEN LAB BEFORE YEAR END


Waters and the Chinese Pharmacopoeia Commission (ChP) have teamed up to establish an Open

Laboratory. The facility is scheduled to open before the end of 2014 and would focus on research of

pharmacopoeia standards, development of testing methods, methods validations and basic and advanced

technical training of pharmacopoeia detection methods. Both the ChP and Waters expect the laboratory to

become one of the national technical support centers in the field of Chinese pharmaceutical standards. "Our

collaboration with the ChP will make positive contributions to assuring drug quality control in China.," said

Art Caputo, President of the Waters Division. At the collaboration agreement signing ceremony in Zhang

Wei, Secretary General ChP Beijing, pointed out that the Joint Open Laboratory cooperation would become

another milestone. This cooperation not only meets the needs of ChP’s own development, but also meets the

demands of enhanced pharmacopoeia standards and improved public drug safety." Located in the laboratory

building of Beijing Zhendong Guangming Drug Research Institute, the new Joint Open Laboratory is more

than 400 sq. m.

BAXTER BUYS US-BASED BIOPHARMA COMPANY, AESRX AND ITS SICKLE CELL

DISEASE PROGRAMME


Baxter International Inc. has acquired AesRx, LLC, a private US biopharmaceutical company focussed on

orphan drug targets, including the development and commercialisation of Aes-103, an investigational

prophylactic treatment for sickle cell disease (SCD). Aes-103 is a first-in-class, oral, small molecule

compound (5-hydroxymethylfurfural). Early studies indicate the compound may work by binding to

haemoglobin and increasing oxygen affinity and stabilisation, thereby reducing the sickling of red blood

cells which, in turn, may reduce sickling-related outcomes such as vaso-occlusive crisis, pain, severe

anemia, and fatigue. Aes-103 has received orphan designation from the FDA and is eligible for orphan

designation in Europe. The Aes-103 programme is currently in a phase 2 clinical trial as part of an ongoing

collaboration with the NIH's National Center for Advancing Translational Sciences (NCATS) through its

Therapeutics for Rare and Neglected Diseases (TRND) programme. Data has previously been presented

from an escalating dose Phase I/2a safety study involving administration of a single dose among stable SCD

patients. The compound, originally patented by Virginia Commonwealth University, was developed by a

team from the VCU Institute for Structural Biology and Drug Discovery, an interdisciplinary research

center spanning the university's Schools of Medicine and Pharmacy.

PAR PHARM BEGINS SHIPMENT OF FLUPHENAZINE DECANOATE INJECTION


Par Pharmaceutical Companies, Inc. has received final approval from the US Food and Drug Administration

for its Abbreviated New Drug Application for fluphenazine decanoate injection, USP 25 mg/mL.

Fluphenazine decanoate injection is a long-acting parenteral antipsychotic drug intended for use in the

management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics).

Fluphenazine decanoate injection has not been shown effective in the management of behavioral

complications in patients with mental retardation. Par has begun shipping the product, which is individually

packaged in 5 mL multiple dose, flip-top vials. According to IMS Health data, annual US sales of

fluphenazine decanoate injection are approximately $20 million. Par Pharmaceutical Companies, Inc. is a

privately held, US-based specialty pharmaceutical company that develops, manufactures and markets high

barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned

subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals.

ASTELLAS SEEKS US FDA APPROVAL FOR ISAVUCONAZOLE TO TREAT INVASIVE

ASPERGILLOSIS & INVASIVE MUCORMYCOSIS


Astellas, a pharmaceutical company dedicated to improving the health of people around the world through

provision of innovative and reliable pharmaceuticals, has submitted a New Drug Application (NDA) to the

US Food and Drug Administration (US FDA) seeking approval for isavuconazole for the treatment of

invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal

infections predominantly occurring in immunocompromised patients. "This NDA submission is a

significant achievement for Astellas’ Infectious Disease franchise and, if approved, isavuconazole will be

another tool physicians will be able to use to combat these serious infections," said Bernie Zeiher, executive

vice president, Global Development and therapeutic area head of Infectious Diseases at Astellas. "There is a

growing need for new antifungal therapies like isavuconazole. Serious fungal infections are on the rise due

to the increasing numbers of immunosuppressed patients such as those undergoing high-dose chemotherapy

and/or haematopoietic stem-cell transplantation for leukaemia." In February, the FDA designated

isavuconazole as a Qualified Infectious Disease Product (QIDP) for invasive mucormycosis. QIDP

designation for the treatment of invasive aspergillosis was granted last year. QIDP status provides priority

review and a five-year extension of market exclusivity in the United States. These incentives were granted

under the 2012 US Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and

Innovation Act. Also, in 2013, isavuconazole was granted orphan drug status for invasive aspergillosis and

invasive mucormycosis.

US DRUGMAKER ABBVIE RAISES OFFER FOR SHIRE TO $51.5 BILLION


AbbVie, the drugmaker split last year from Abbott Laboratories, made a fourth offer to buy Shire, raising

the price to about 30.1 billion pounds ($51.5 billion) in an effort to bring Shire to the negotiating table.

AbbVie increased the offer by about 11% to 51.15 a share in cash and stock, the company said in a

statement today. Previously, AbbVie made three bids, escalating to 27.3 billion, a price that Shire's board

unanimously rejected, saying it undervalued the company. 'AbbVie has made a compelling offer to Shire

that creates immediate and long-term value to shareholders of both companies," Richard Gonzalez,

AbbVie's chief executive officer, said in the statement. "We think its shareholders should strongly

encourage the Shire board to engage in constructive dialogue with AbbVie." Buying Shire would allow

North Chicago, Illinois-based AbbVie to have its tax domicile in the UK, which has a lower tax rate than

the US. The addition of Shire's array of rare disease treatments and drugs for attention deficit hyperactivity

disorder would also diversify AbbVie's product portfolio, which is currently dominated by a single

medicine, the arthritis therapy Humira. Flemming Orn-skov, Shire's CEO since May last year, has argued to

keep his company independent, projecting that product sales will double to $10 billion by 2020 as Shire

expands in drugs for eye maladies and other rare diseases.

SOLIGENIX'S COMBO VACCINE FOR RICIN & ANTHRAX ACHIEVES SIMULTANEOUS

PROTECTION


Soligenix, Inc. announced that the combination of RiVax and VeloThrax induces protective immunity to

both ricin toxin and anthrax toxin exposure. RiVax is the company's candidate vaccine for the prevention of

exposure to ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin.

VeloThrax is the company's candidate vaccine that employs a derivative of recombinant protective antigen,

termed Dominant Negative Inhibitor (DNI), which is a candidate for inclusion in a next generation anthrax

vaccine. When administered as single a vaccine, each vaccine induced antibodies that were capable of

neutralizing the toxin from which the vaccine had been derived. VeloThrax induced neutralizing antibodies

against anthrax toxin and RiVax™ induced antibodies against ricin toxin. When combined, the dual vaccine

induced antibodies that were reactive against both toxins and these neutralizing antibodies were detected

until at least 200 days after the immunization regimens. Consequently, the combined vaccination provided

protection to exposure to both ricin toxin and anthrax toxin that persisted for at least six months after 2

vaccinations, suggesting that long-term immunity upon simultaneous vaccination can be achieved.

Soligenix performed these studies in collaboration with the Wadsworth Institute of the New York State

Department of Health, with Dr. Nicolas J. Mantis, Dr. David Vance and collaborators under the aegis of a

$9.4 million cooperative grant from the National Institute of Allergy and Infectious Diseases (NIAID).

XELLIA PHARMA BUYS FRESENIUS KABI’S LYOPHILIZED VIAL MANUFACTURING UNIT

IN NORTH CAROLINA


Specialty pharmaceutical company, Xellia Pharmaceuticals (Xellia) has acquired Fresenius Kabi’s dedicated

lyophilized (freeze-dried) vial manufacturing facility in Raleigh, North Carolina. The deal includes a

continuous manufacturing and supply agreement with Fresenius Kabi USA. Financial details are not

disclosed. The manufacturing site is located close to the world famous Research Triangle Park and is

Xellia’s first facility in the US significantly expanding the Company’s manufacturing capacity for injectable

pharmaceutical products. Xellia intends to retain all ~80 staff currently employed at the site and will

continue to manufacture certain products at the site for Fresenius Kabi. In the future Xellia plans to employ

more staff as it expands the site further. Commenting on the acquisition Carl-Åke Carlsson CEO Xellia

said: “This is a great opportunity for us to expand our manufacturing capabilities into the US which is a key

market for us. We have great respect for Fresenius Kabi and its employees and have been in partnership

with the company for years as a preferred trusted supplier of active pharmaceutical ingredients. I believe

this acquisition will be a win-win situation benefiting both companies and our customers.” “This agreement

is part of our global strategy to optimize our manufacturing and supply network” said John Ducker

president and CEO Fresenius Kabi USA. “Both companies are committed to assure a smooth and seamless

transition for customers and employees. This transaction will have no impact on Fresenius Kabi’s ability to

meet customer demand for the products we currently manufacture at the Raleigh site and we continue to

work closely with the FDA to alleviate US drug shortages.”

CASI PHARMA'S AURORA A/ANGIOGENIC KINASE INHIBITOR, ENMD-2076 GETS US FDA

ORPHAN DRUG STATUS TO TREAT HCC


The US Food and Drug Administration (FDA) has granted Orphan Drug designation to CASI

Pharmaceuticals' orally-active, Aurora A/angiogenic kinase inhibitor, ENMD-2076 for the treatment of

hepatocellular carcinoma (HCC). Orphan Drug designation is granted by the FDA Office of Orphan

Products Development, which evaluates scientific and clinical data submissions from sponsors to identify

and designate products as promising for rare diseases and to further advance scientific development of such

promising medical products. Orphan Drug designation is granted to therapeutics treating rare diseases

affecting less than 200,000 people in the US. The designation entitles the sponsor to seven years of market

exclusivity as well as opportunities for additional funding and expert protocol assistance.

GRUNENTHAL SUBMITS EUROPEAN MARKETING AUTHORISATION APPLICATION FOR

ZALVISO


Grunenthal Group, an independent, family-owned, international research-based pharmaceutical company,

has submitted a Marketing Authorisation Application (MAA) to the European Medicines Authority for

Zalviso for the management of moderate to severe acute pain in adult patients in a medically supervised

environment. Zalviso is a drug-device combination product utilising the opioid agonist sufentanil

formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-

invasive proprietary delivery device. AcelRx Pharmaceuticals, Inc. and Grunenthal entered into licence and

supply agreements for Zalviso in the EU, Australia and certain other countries in December 2013. Under the

terms of the licence agreement, AcelRx will receive a cash payment of $5 million for the MAA submission.

AcelRx is eligible to receive an additional $15 million milestone payment upon the approval of the MAA.

After approval by EMA, AcelRx is eligible to receive approximately $200 million in additional milestone

payments, based upon successful regulatory and product development efforts and net sales target

achievements. Grunenthal will also make tiered royalty, supply and trademark fee payments in the mid-

teens up to the twenty per cent range, on net sales of Zalviso in the Grunenthal territory. With the

partnership Grunenthal, a family-owned global pharmaceutical company headquartered in Aachen,

Germany, significantly strengthens its hospital franchise and underlines its strong market position as a pain

specialist in the pharmaceutical market.

ORGENESIS INKS PACT WITH MASTHERCELL TO SCALE MANUFACTURING OF

INSULIN-PRODUCING LIVER CELLS TO COMBAT DIABETES


Orgenesis Inc, a leader in the emerging fields of cellular therapy and re-generative medicine announced that

its Belgian subsidiary, Orgenesis SPRL, has signed a strategic agreement with MaSTherCell SA of

Gosselies, Belgium. Orgenesis believes that the agreement will enable Orgenesis to advance its

manufacturing (GMP) process from lab scale to clinical scale as it prepares for phase I and phase II clinical

trials. “The team at MaSTherCell has the right mix of capabilities, experience, technology and

manufacturing processes in place to make it a natural fit for Orgenesis and will give us scalability in our

efforts to have a significant impact on Type 1 diabetes,” said Jacob BenArie, chief executive officer, of

Orgenesis Ltd. and Orgenesis SPRL. “We wanted a partner with a centrally located facility in Europe.

MaSTherCell is located in the Walloon region of Belgium with access to a large biotech talent pool which

they may tap into as we scale up our operations and activities.” Orgenesis is a pioneer in the field of

‘cellular trans-differentiation’, a process that the company is developing to transform a type 1 diabetic

patient’s own liver cells into new insulin-producing cells. Cellular trans-differentiation involves a complex

biologic process, and requires sophisticated manufacturing technology and capabilities. MaSTherCell has

the experience, system design and cutting-edge technology in place to deliver the control properties and

conditions needed for the live cell culture and expansion process critical to commercial scale manufacture

of Orgenesis cellular trans-differentiation products.

MARIEL TO BUY STRYKER'S BONE MORPHOGENETIC PROTEIN-7 ASSETS FOR

TREATMENT OF OSTEOARTHRITIS & ORGAN FIBROSIS


Mariel Therapeutics, Inc, a clinical stage biopharmaceutical company ,has entered into a definitive

agreement to acquire Stryker Corporation's Bone Morphogenetic Protein-7 (BMP-7) assets for the potential

treatment of osteoarthritis (OA), chronic kidney disease (CKD) and other organ fibrosis conditions, lupus,

and obesity. Under the terms of the agreement, Mariel acquired the rights to over 450 issued and pending

patents, Stryker's BMP-7-related clinical and research data, and the associated biologic materials. Stryker

will have a right of first negotiation for commercial rights in the area of osteoarthritis. Financial terms of

the transaction were not disclosed. Human recombinant BMP-7 has previously been used in reconstructive

bone applications in over 40,000 patients. Previous phase I and phase IIa trials have been completed in

osteoarthritis. Mariel intends to pursue a phase IIb/III clinical trial for osteoarthritis (OA) and phase I trials

for chronic kidney disease (CKD) and Alport's disease, a genetic kidney fibrosis disease. Mariel

Therapeutics, Inc. (Mariel) is a clinical stage biopharmaceutical company focused on the clinical

application of Bone Morphogenetic Protein-7 (BMP-7) in osteoarthritis (OA), chronic kidney disease

(CKD), and Alport's Syndrome.

BGI PRESENTS HIGH-QUALITY GENE CATALOG OF HUMAN GUT MICROBIOME, A KEY

TO UNDERSTANDING HUMAN HEALTH & DISEASES


Researchers from BGI, working within the Metagenomics of the Human Intestinal Tract (MetaHIT) project,

and in collaboration with other institutions around the world, have established the highest quality integrated

gene set for the human gut microbiome to date- a close-to-complete catalogue of the microbes that reside

inside us and massively outnumber our own cells. While the roughly 20,000 genes in the human genome

have been available for over a decade, the gene catalog of the microbiome, our much larger “other

genome”, has to date been much more poorly understood and characterised. The data released from this

study should facilitate further research on the interactions between human and microbial genomes, and

brings us closer to an understanding of how to maintain the microbial balance that keeps us healthy. The

latest study was published online in the journal Nature Biotechnology Each of our guts is colonised by more

than 3 pounds of micro-organisms that can break down toxins, manufacture vitamins and essential amino

acids, and form a barrier against invaders. However, until now there has been a lack of comprehensive and

uniformly processed database resources cataloging the human gut microbiota around the world, which has

hindered our knowledge of the genetic and functional mechanism of human gut microbes. In this study,

researchers established a catalog of the human gut microbial genes by processing 249 newly sequenced

samples and 1,018 published samples from MetaHIT, Human Microbiome Project (HMP) and a large

diabetes study from China, as well as 511 sequenced genomes of gut-related bacteria and archaea. This

expanded research is at least three times larger than the cohorts used for previous gene catalogs. Based upon

the catalog, researchers investigated the gut microbiota of healthy Chinese and Danish adults, and found the

two cohorts greatly differed in nutrient metabolism as well as xenobiotic detoxification, which might be

influenced by the differences in diet and environment.

WELLNESS

HUL TAKES ON COLGATE WITH NEW WHITENING TOOTHPASTE

Business Standard, 6 July, 2014

A year after oral care major Colgate launched Visible White, a whitening toothpaste that claims to make

teeth a few shades lighter, rival Hindustan Unilever (HUL) has come up with an answer to it in Close-up

Diamond Attraction. The product, priced at around Rs 40 for a 50 gm pack (Rs 79-80 for 100 gm), claims

teeth can get lighter after one brush, thanks to a patented blue light technology that works instantly on teeth.

Colgate’s Visible White, priced at Rs 43 for a 50 gm pack (Rs 84 for 100 gm), on the other hand, claims that

teeth can get whiter after a week’s use. This is the second time that HUL is taking the fight in toothpaste

efficacy to Colgate’s doorstep. Last year, HUL had launched a commercial for Pepsodent Germichek that

compared the product's germ attack power with Colgate’s Strong Teeth saying it had 130 per cent superior

germ attack power over the latter after four hours of brushing. Colgate had subsequently dragged HUL to

court over the matter, with the latter getting relief in the case. While HUL is yet to advertise its newest

launch, the product is visible on shop shelves. Atul Sinha, category head, oral care, HUL, said, “We believe

Close-up Diamond Attraction will be a game changer in the category as it transcends from oral care into the

beauty space. Co-created with cosmetic dentists, the product is proven to give visibly white teeth from the

first brush itself. It is a must-have for new-age beauty kits.” But analysts say HUL will have to push the

brand really hard if it has to catch-up with Visible White, which has a year’s headstart.

NESTLÉ US REDUCES WASTE BY 44% SINCE 2010

Sustainable Brands, 7 July, 2014

Nestlé has reduced 44 percent of its waste per ton of product since 2010 in the US, and five factory

locations reached zero waste to landfill status by the end of 2013, according to the company’s new

sustainability report. The Creating Shared Value (CSV) report is the company’s first expanded effort to

highlight U.S.-specific milestones and achievements tied to Nestlé’s global sustainability principles and

commitments. The report documents the food giant’s nutritional, social and environmental progress from

the past year, as well as provides updates on the company’s US progress toward its global commitments.

Other notable environmental impact updates include saving more than 3.3 billion pounds of plastic since

2003 by reducing the plastic content of its PET ½-liter water bottles by 60 percent. Nestlé is already on its

way to achieving zero waste in Europe by 2020. On the supply chain front, last year Nestlé says it achieved

its goal of sourcing 100 percent Roundtable on Sustainable Palm Oil (RSPO)-certified palm oil. The

company also implemented Responsible Sourcing Guidelines for seafood that align with its global

Responsible Sourcing Guidelines, working with experts to track suppliers and contribute to healthier

ecosystems. In 2013, Nestlé also committed to sourcing 100 percent certified cocoa beans for its Crunch

Bars. Addressing growing health concerns in the US, Nestlé rolled out new portion guidance tools and

launched an educational campaign, Balance Your Plate, to help consumers build nutritious and convenient

meals that meet the Dietary Guidelines for Americans.

UNILEVER TO BOOST PRODUCTION CAPACITY IN SECOND HALF

Jakarta Post, 8 July, 2014

Consumer goods maker PT Unilever Indonesia has earmarked up to Rp 1.4 trillion (US$ 119.53 million) in

capital expenditure this year in particular to boost the capacity of its factories and improve brand innovation

in the second half. Unilever Indonesia, the local arm of Anglo-Dutch multinational company based in

London, will focus on improving the company’s sales distribution, notably its ice-cream products, and

increase the production capacities of its existing factories, according to external relations director and

corporate secretary Sancoyo Antarikso. “Some of our plans to improve distribution include the addition of

ice cream storage at several of our retail locations,” Sancoyo said during a Unilever event in Jakarta on

Monday. Unilever Indonesia operates the ice cream brand Wall’s, which is available in various grocery store

and convenience store locations. Aside from Wall’s, it produces and distributes another 30 brands of food,

home and personal care products nationwide. Furthermore, the company’s numerous factories in the

Jababeka Industrial Estate in Cikarang, West Java and in the Rungkut Industrial Estate in Surabaya, East

Java will have their production capacities expanded as part of the capital expenditure plans. While Sancoyo

explained that no new factories or warehouses were planned for this year, the corporate secretary mentioned

that the company’s planned oleochemical production plant located in the Sei Mangkei Special Economic

Zone in Simalungun, North Sumatra, would likely be commissioned in October.

INDUSTRY AND ECONOMY

NEED TO REDUCE COST OF PROVIDING HEALTHCARE SERVICES: NATHEALTH


India needs to reduce the cost of providing healthcare services as this results in limiting the investments in

the sector due to long payback periods, an industry body has said. To ensure this, the government should

address the root cause of issues of access and availability, affordability and quality, healthcare sector

federation NATHEALTH has said. To address the multiple issues facing the sector, it has submitted a pre-

budget wish list to the government. It has urged the government to lower the cost of setting up healthcare

facilities. As part of this it has called for finalising details of guidelines, scope and provisions under granted

infrastructure status to the healthcare sector as this would help to raise lower cost funds. "RBI's recognition

of infrastructure status would enable fund raising through infrastructure bonds and via other agencies at

lower rates," NATHEALTH said. It would also lead to access to government and infrastructure oriented

funding (from agencies such as IIFCL, IL&FS, Rural Infrastructure Development Fund), it added. The

federation has also sought corporate income tax incentives on capital expenditure for facilities (greenfield

hospitals) with 50 beds (this is currently allowed only for hospitals with 100 beds and above) and has also

asked for extended tax holiday for establishing these facilities.

LACK OF VACCINE POLICY BOON FOR PRIVATE PLAYERS


There is a reason why the vaccine market goes into a tizzy when India goes shopping. The Indian

government including a vaccine in its Universal Immunisation Programme (UIP) is equivalent to getting the

market of over 60 rich countries in one shot. India has more babies being born annually than the 41

countries of the European Union and OECD and 20 of the Middle East put together. Public health activists

point out that this is why India ought to have a stringent national vaccine policy with a clear-cut protocol to

determine need and cost effectiveness for a vaccine to qualify for inclusion in the UIP. Not having such a

policy helps vaccine manufacturers use every trick in the book to make India buy their vaccines. After all,

the target is a market of 27 million babies being born annually. That's one in every five babies born globally.

The total number of annual births in the European Union and the OECD countries is about 16 million. The

total number of births in the 20 Middle East countries is 10 million. Put together, the babies born in these 61

countries — 26 million — still fall short of the 27 million being born in India. "It would be far simpler for

companies to lean on one government in India rather than having to persuade so many more governments in

countries with far stricter regulations," said Madhavi Yenappu, principal scientist in the National Institute of

Science Technology and Development ( NISTAD) who researches vaccine policy. China accounts for 16

million births annually. South Asia, including India and excluding China, would account for 28% or 37

million of the 135 million births happening globally. Thus South Asia's eight countries have as many babies

being born as are estimated to be born in almost 100 countries if we were to include Latin America and the

Caribbean to the earlier group (EU+OECD+Middle East). "With such a huge child population, vaccine

security is crucial for India. It could even have become the producer of vaccines for all of South Asia.

OVER-COUNTER DRUGS FUEL TB THREAT

Times of India, 10 July, 2014

Doctors are waging a losing battle against tuberculosis with chemists indiscriminately selling drugs over the

counter. Four months after the Union health ministry's ban on the sale of 46 drugs without prescription, the

contribution of pharmacists in the city to the growing pool of drug-resistant bacteria remains unabated.

Doctors say repeated and wrong use of antibiotics is the main cause of increase in drug-resistant bacteria.

Although the state Directorate of Drug Control promised strict action against medical stores selling these 46

drugs, mostly for TB and respiratory ailments, without prescription, most drugs are available over the

counter in many pharmacies in the city In 2013, the Union health ministry introduced a new schedule in the

Drugs and Cosmetics Act, which came into force on March 1, 2014. The schedule has made it almost

impossible to buy antibiotics, anti-TB and habit-forming drugs without prescription from a

registeredmedicalpractitioner. Director of Drugs Control Abdul Khader said, "We have been checking if the

536 drugs under the previous H schedule are being sold withoutprescrip-tion. We have also sent a directive

to all pharmacies to add the new list to their sale records," he said. Since last June, 217 stores were booked

for selling antibiotics without prescription, he added. But many pharmacies TOI visited in T Nagar, Anna

Nagar, Nungambakkam and Vadapa-lani didn't have a prescription registry as mandated in the new

schedule. Some claimed they were unaware of the new schedule, some brought out dusty registers with the

last entry made months ago, while many refused to show the registry The new schedule includes 24

antibiotics, 11 anti-TB drugs and 11 psychotropic drugs. The packaging of these drugs will have mandatory

warning printed on them in a box with a red border on the label and will be sold by chemists on production

of a prescription.

PUNJAB RIDES HIGH ON PHARMA-INTOXICANTS

The Hindu Business Line, 10 July, 2014

The increasing seizures of drugs, especially heroin, in recent years show that Punjab has emerged as a major

transit point for those in the illegal drugs trade. But the State itself, facinga worrying drugs menace, is

hooked on pharmaceutical intoxicants as well. Well-placed sources in the Punjab police say the

consumption of intoxicants with a pharmaceutical origin has become a major problem in the State. Rise in

seizures The seizures of pharma-based intoxicants in recent years tell the story. Against over 6.1 million

pills and capsules seized in 202, three crore such intoxicants were seized last year. The recovery of

pharmaceutical injections went up from 30,572 in 2011 to 323,056 last year. The seizure of intoxicant

powder went up from 321 kg in 2011 to 613 kg last year. Habit forming drugs include Parvon Forte and

Spas-mocip, apart from Fancidryl (Phencidryl) cough syrup. Synthetic drugs include Di-phenoxylate

Hydrochloride and Codeine Phosphate. "Heroin consumption in Punjab is minimal. The incidence of smack

consumption has increased. The worrying factor is the high consumption of pharmaceutical-origin

intoxicants, especially by the youth," a senior police officer associated with investigations against drug

cartels told IANS. "We have been able to break the transit and supply lines of the drugs cartels operating in

India.

ECONOMIC SURVEY 2014: 'MORE NEEDS TO BE DONE TO GIVE QUALITY, AFFORDABLE

HEALTHCARE'


Stating that a mere 1.4 per cent of GDP is spent on healthcare, the Economic Survey today highlighted the

need for more vigorous efforts to provide quality and affordable healthcare to the country's population,

particularly to the poor and the underprivileged. "Expenditure on health is just 1.4 per cent of GDP. A lot

more needs to be done to provide quality and affordable healthcare for the large Indian population," the

Economic Survey for 2013-14 said. The allocations for the health sector have increased over the years, it

added. The central government outlay for the health sector in the 12th Plan has been increased by about 200

per cent to Rs 3,00,018 crore over the actual outlay of Rs 99,491 crore in the 11th Plan, the survey said. The

pre-Budget document tabled in the Parliament today by Finance Minister Arun Jaitley said in selected

parameters, the progress made in health sector, however, has been impressive. For instance, infant mortality

rate per 1,000 live births has come down to 42 in 2012 as compared to 110 in 1981. Likewise, maternal

mortality ratio per one lakh live births has come down to 178 in 2010-12 as compared to 301 in 2001-03.

The government has also launched many programmes in the health sector. The national health mission

(NHM) was launched in 2013 to enable universal access to equitable, affordable, and quality health care

services. The total plan outlay under the NHM for 2013-14 was Rs 18,775.35 crore.

BUDGET 2104: RAISING OF FDI CAP IN INSURANCE MAY HELP PHARMA INDUSTRY,

SAYS EXPERTS


The hike in FDI cap in insurance is expected to help patients as well as the pharma industry, say experts.

"The hike in insurance investment limit to 49 per cent is expected to help both the patients and the pharma

industry. Free drugs and free diagnostics for all sounds potentially promising for patients," PwC India

Leader (Pharma and Life Sciences) Sujay Shetty said. In a big relief to the capital-starved private insurance

sector, Finance Minister Arun Jaitley today proposed raising the FDI cap from 26 per cent to 49 per cent.

Presenting his maiden Budget, Jaitley also said that to move towards "Health for All", two key initiatives

like the free drug service and free diagnosis service would be taken up on a priority basis. The Budget

provisions to enhance both financial and physical access of healthcare for the country is a welcome step,

PwC India Leader (Healthcare) Rana Mehta said. Through broadband in rural areas, telemedicine will

increase the accessibility of qualified doctors and specialists and increased FDI in health insurance to 49 per

cent will help increase financial accessibility of population, he said.

BUDGET 2014: PHARMA SECTOR LEFT AILING FOR REMEDIAL MEASURES


Finance Minister presented the much awaited maiden Budget of the new BJP-led government yesterday.

Given the prevailing situation of low growth combined with high inflation and a large fiscal deficit, the

budget was anticipated with a sense of hope and aspiration, the belief that it would ring in achche din, albeit

in the long run. While the cash-strapped Government was not expected to announce massive sops for

industry, it was nevertheless hoped that the Budget would provide directional clarity as to what the next five

years are going to look like. The provisions and announcements in the budget are focussed towards the

Government's commitment of "Health for All", especially "Free Drug Service" and "Free Diagnosis

Service". To achieve the same, Government announced some positive steps such as opening of new AIIMS

like institution, creation of new drug testing laboratories, 15 Model Rural Health Research Centres,

strengthening of at least five research centres (which interalia includes research in bio-medical technology

devices). On the indirect tax front, while the government has provided for full exemption from customs

duty for HIV/AIDS drugs and diagnostic kits imported under National AIDS Control Programme funded by

the Global Fund to Fight AIDS, TB and Malaria, on the whole pharmaceutical sector does not seem to have

much to cheer about. Levy of service tax on clinical trials on humans is likely to add to the challenges

which this industry is facing around the regulatory policies. Also, while FM addressed the issue surrounding

the inverted duty structure for various sectors, the pharma sector seems to have been left out, this has been a

long standing demand. On the direct taxes front, the Government has lowered threshold limit of investment

in plant & machinery for providing an investment allowance of 15% from INR 100 crores to INR 25 crores.

A welcome move for pharma companies looking for fresh investments in manufacturing assets. No

retrospective amendments in the tax laws which creates a fresh liability High level committee to be

constituted by the CBDT to scrutinize all fresh cases arising in respect of indirect transfers coming to the

notice of the tax officer Setting up high level committee to interact with trade and industry on a regular

basis and ascertain areas where clarity in tax laws, should be helpful. Long drawn litigation has been one of

the serious concerns of all the tax payers in India.

HEALTHCARE NEEDS A STRONG DOSE Financial Express, 11 July, 2014

THE BUDGET presented by finance minister Arun Jaitley looks positive for the overall industrial

development as there are a slew of positive measures that can support industries across the sectors. The

Budget highlights the new government's rational approach toward policies on taxation, government

spending and growth, infrastructure, real estate and financial sectors. The Budget's focus on rationalising

tax arbitrages and anomalies across various items, acknowledging need for taxation clarity on retrospective

amendments and advance rulings are welcome. Simplification of some tax laws is a welcome move by the

government. The attention given to the healthcare, transportation, education and energy sectors '

requirement is the need of the hour. If the government is able to deliver on these proposals, it would help in

achieving the fiscal deficit targets. Setting up of four new All India Institutes of Medical Sciences (AIIMS)

and earmarking Rs 500 crore for this are positive moves. The mention of affordable healthcare is a sign of

development, creation of new drug testing laboratories and 15 model rural health research centres are steps

in right direction. In terms of delivery of healthcare, Budget's emphasis on win-win model of public-private

partnership (PPP) enhances both flexible innovation and funding options. While we are yet to see the details

of the provisions in the Budget, the pharmaceutical industry is missing some key issues, like infrastructure

status to the healthcare industry.

A NON-EVENT FOR INDIAN PHARMA Financial Express, 11 July, 2014

THE UNION BUDGET 2014-15 is a growth-oriented, balanced and pragmatic one — given the context of

the precarious state of the country's finances with GDP growth being below 5 % for the past two years.

While finance minister Arun Jait-ley's promise of an economic revival with return to 7-8 % GDP growth in

the next three to four years is encouraging, one needs to wait and watch how the government plans to

execute its plan to put the economy back on the fast growth track. Also, encouraging are measures for

reining in inflation with special focus on manufacturing, infrastructure building and skill development. It

has spelt out its commitment to public-private partnerships (PPP) to drive investment. The FM has also

acted positively to further develop and bring in quality in higher education and encourage skill-development

programmes. The government also seems to be committed to strengthening investor confidence in the

economy The government's plan to approve goods and services tax (GST) by the end of the year is a

positive move indeed, which will help in simplifying and streamlining the indirect tax regime and will

benefit all industries. Though, more clarity on the roadmap to GST was required. The finance minister

needs to be lauded for his assurance of providing affordable healthcare to all in his maiden Budget speech.

Announcement of measures like providing free drug-and-diagnostic services to needy patients and the

vision of creating AI-IMS in every state of the country shows this intent. It is important to address the

critical challenge of providing access to high-quality medicines and medical treatment to our 1.2 billion-

plus population and one wished that there were more specific measures announced in this direction. For

long, the Budget has been a non-event for the pharmaceutical sector in particular and the Union Budget

2014-15 is no exception. Hence, we were not surprised when there were no specific incentives announced

for the sector.

GOOD INTENTIONS, BUT NO BIG HEALTHCARE IDEA, SAY EXPERTS The Hindu Business Line, 11 July, 2014

The increased tax on tobacco and aerated sugar water notwithstanding, healthcare representatives are

unhappy that Budget 2014-15 has "effectively given healthcare the go by". From public-health workers who

were hoping that the "Modi-budget" would increase Government spending on healthcare, to the

pharmaceutical industry looking for incentives to support this strategic sector, disappointment is the

common thread. Though the Budget may be "di-rectionally good", there is not a single big idea, says Arvind

Sing-hal, Chairman, Technopak Advisors. The plan to have AIMS (All India Institute of Medical Sciences)

hospitals in every State, for instance, is good, but will it have the desired impact, he asks. A world-class

AIIMS hospital would require a Rs2,000-crore investment, he says, adding the Government has earmarked

about Rs500 crore. The scale of investment and the number of hospitals need to be much more. "India needs

half a million hospital beds right now," says Singhal. Novartis India-head Ranjit Sha-hani seems to agree.

"Given the mandate, this was a sterling opportunity, but missed to make structural changes. Not only was

the big idea missing but even the allocations made speak of the tokenism with which such an important

topic has been treated with." Taxing trials Even the little that has been mentioned is either unclear or

worrisome, say industry representatives. Indian Pharmaceutical Alliance's DG Shah is concerned about the

withdrawal of service tax exemption on testing newly developed drugs on humans. This would make

clinical trials expensive for foreign companies doing such trials in India, even as it makes it more

challenging for domestic companies trying to develop new drugs, he says. Another industry representative

points out that the fluid regulatory framework has all but stopped clinical trials in India.

PHARMA SECTOR LOOKS FOR INCENTIVES, R&D PUSH, NIMZ TO DRIVE GROWTH

Financial Chronicle, 10 July, 2014

THE Rs 70,000 crore pharma industry is at a turning point where it has pinned hopes on a booster dose

from the government fhat could get them back on track. Financial incentives, a push for R&D and revival of

bulk drugs are what the sector is eyeing. Lately, the only excitement for pharma companies is the setting up

of eight new national investment and manufacturing zones (NIMZ) of a total of 16 announced by the

previous government. Through such zones the sector may get the much-needed API (active pharmaceutical

ingredients) manufacturing push, which has slackened owing to cost competitiveness from China. "The

Indian pharma sector needs some structural fine-tuning and it can meet the intensive global regulatory

requirements. Going forward, there are positive signals that the pharma sector may thrive. Setting up of

manufacturing zones is the first step towards the concept of developing an ecosystem for specialties- and

sub-specialties," said Santosh Varlwar, managing director of Vivimed Labs. The eight new NIMZs will be

located at Nagpur, Chittoor, Medak, Prakasam, Tumkur, Kolar, Bidar and Gulbarga. "In the last ten years

the pharmaceutical industry has largely been ignored. However the setting up of NIMZ is a positive sign as

an indication of things to come. Right now pharma companies are located only at Telangana, Andhra

Pradesh, Himachal Pradesh and' Haryana," said Avinash Lodha, associate director of India Ratings. Such

clusters can be helpful for big and small pharma companies as sometimes land costs can zoom up to around

500 per cent in private pharma zones, which makes it difficult for setting up units. Apart from

manufacturing, what is needed is collaboration of industry and universities to beef up R&D."

USFDA DIRECTIVES TO PUSH UP PHARMA COST IN INDIA: CRISIL

Political Business Daily, 9 July, 2014

STRICTER norms by American drugs regulator USFDA will lead to higher compliance costs for Indian

pharma, although these enforcements are not country specific but more on account of "cultural differences",

said a report by global credit rating agency Crisil. The companies have little choice but to invest in bringing

compliance processes up to speed, it said, adding that the cost of not doing so (warning letters-import alerts

may impact both current revenues and future pipel-ine) will be far higher. In general, the cost of compliance

of drug makers has doubled over the past 5 years. About 30 per cent -or USD 4 billion worth - of India's

pharma exports are to the US. India remains a location of significant importance to the FDA as it has the

largest number of FDA-approved drug- manufacturing plants with over 150 formulation facilities and is

also the second-largest pharmaceutical supplier to the US market in terms of volume of generic drugs. The

enforcements by US Food and Drug Administration over Indian pharma companies, though not country

specific, are mainly on account of issues such as cultural differences and attitude of employees, it said.

ARE NEW, COSTLY VACCINES NEEDED?


If the recently announced introduction of newer, more expensive vaccines into the Universal Immunisation

Programme (UIP) has to be implemented, the budget allocation for vaccine procurement will have to go up

six times by over Rs 5,200 crore in the forthcoming budget, back-of the envelope calculation show. That's

just to maintain the current level of immunization coverage of less than 75% of all the children who should

be covered. The calculation also does not take into account the additional costs of boosting infrastructure

and training personnel required for the delivery of these new vaccines. Earlier, the cost of immunizing a

child under the UIP was roughly Rs 100 including the cost of syringes (Rs 2.5 per syringe). With the newer

vaccines, the cost per child could go up to Rs 1,000 or ten times the current cost. However, GAVI (formerly

the Global Alliance for Vaccines and Immunisation) is supplying the pentavalent vaccine, the most

expensive among the new vaccines, worth Rs 390 per child, free of cost till 2015 end. Hence, the immediate

cost per child will be about Rs 600. Over the long run, health ministry officials believe the cost of many of

the newer vaccines could drop significantly after they are introduced in the UIP. Here's how the calculation

works: In 2012-13, the government spent over Rs 1,045 crore to procure vaccines. At six times the cost, that

would mean Rs 6,270 crore at the new cost. That's to cover about 75% of the children. To achieve 100%

coverage, the cost of procuring vaccines would go up to more than Rs 8,300 crore.

GOVT ADDS 4 MORE VACCINES TO IMMUNISATION PROGRAMME


The Government has decided to introduce four new vaccines as part of the universal immunisation

programme (UIP), Prime Minister Narendra Modi announced on Thursday. Three vaccines—against

rotavirus, rubella and polio (injectable) — will be introduced under this programme, besides an adult

vaccine against Japanese encephalitis (in 179 districts in nine States with high cases of encephalitis).

Earlier, in June, Health Minister Harsh Vardhan had announced that the Government would start a mass

immunisation programme against Japanese encephalitis and acute encephalitis, in severely affected States.

Uttar Pradesh and Bihar have particularly high incidence of encephalitis, with the annual death toll totalling

to 500-600 in UP itself. "With these new vaccines, India's UIP will now provide free vaccines against 13

life threatening diseases to 27 million children annually," an official statement said. According to the

announcement by Modi, India is, now also going to move towards adding injectable polio vaccine (IPV),

which is recognised to be safer, to the oral immunisation scheme.

This move was also recommended by the World Health Organisation (WHO) after India received the polio-

free status earlier this year. Oral vaccines, used in the Pulse Polio campaign, are effective in protecting

children from three strains of the polio virus especially because it is cost effective as well as easy to

administer. However, now that India has officially eradicated polio, the Government is looking to move

towards the injectable vaccine for additional protection. "The introduction of four new Iifesaving vaccines,

will play a key role in reducing the childhood and infant mortality and morbidity in the country. Many of

these vaccines are already available through private practitioners to those who can afford them. The

Government will now ensure that the benefits of vaccination reach all sections of the society, regardless of

social and economic status," Modi said. The Government estimates that this new move will prevent at least

1 lakh infant deaths, deaths of adults in working age group and up to 10 lakh hospitali-sations each year.,

MSACS GRAPPLES WITH SHORTAGE OF SECOND-LINE DRUGS FOR HIV PATIENTS

Indian Express, 5 July, 2014

THE Maharashtra State AIDS Control Society (MSACS) is struggling to ensure a consistent supply of drugs

for HTV patients who are on second-line anti retroviral treatment. In Pune. B J Medical College and

Sassoon general hospital just got its consignment of Atazanavir — a crucial drug to treat those on second-

line treatment — while places such as Sangli and Au-rangabad will get their share in a day or two. The ART

centre at Sassoon general hospital that provides free drugs to registered 5,961 HTV positive patients whose

CD 4 count is less than 350, has another 711 patients on second- line of treatment as they have developed

resistance to the earlier drugs. The paediatric dosage of Lopinavir in syrup form is also in short supply.

Officials, however, said tablets are being given to the children. Lack of refrigeration facility has halted the

transport of this drug (syrup) from Satara. "We will get the facility soon," officials at ART told Newsline.

While stock of some of the drugs such as Abacavir will last for 55 patients for a month, Sassoon only

received the second line drug Atazanavir recently. "We had no option but to give drugs to the patients for a

week. However with the new stock we can provide drugs for a month," said an officialsfrom BJMC.

INDIA HEAVILY RELYING ON CHINESE DRUGS

Metro India, 5 July, 2014

Alongside India building an unenviable reputation of being the pharmacy of the world supplying reliable

and affordable medicines to over 200 countries, lesser known fact is that the country has become heavily

import dependent on China when it comes to many essential and large volume drugs making us vulnerable

to sudden disruption of supplies, an Assocham study on "Pharmaceuticals Sector in India: Challenges faced

& Suggested Way Forward" has cautioned. "One of the perceptible challenges before the Indian

pharmaceutical industry is the gradual erosion of domestic manufacturing capacity for certain keys APIs

(Active Pharmaceutical Ingredients) and their advanced intermediates", said Umang Chaturvedi, co-

chairman, Assocham National Council on Drugs and Pharmaceuticals & global head-corporate affairs, Ran-

baxy Laboratories, Manisha Singh, head of Corporate Law Group and D S Rawat, secretary general,

Assocham. Over a period of time, Indian players have steadily migrated up the value chain to focus on

value-added formulations with higher margins. As a result, India is today severely dependent on imports for

many essential and large-volume drugs. It said since bulk of this large volume but essential comes from

China, Needless to say, that this lack of self-sufficiency poses significant risk, given that most of India's

drug imports are concentrated in China.

'CHINA IMPORTS MAY HARM PHARMA'

Business Standard, 5 July, 2014

A latest study has warned the Indian pharmaceutical sectorof a sudden disruption in drug supplies as well as

price rise as it is heavily dependent on China for essential and large volume drugs. "One of the perceptible

challenges before the Indian sector is the gradual erosion of domestic manufacturing capacity for certain

key active pharmaceutical ingredients and their advanced intermediates", said a study conducted by

Assocham. As Indian companies are moving up the value chain to focus on value-added formations with

higher margins, they have become dependent on imports for many essential and large-volume drugs, the

study said.

PHARMA INDUSTRY WANTS DRUG PRICE CONTROL EASED


The pharmaceutical industry has called for reducing drug price control, ahead of the Union Budget which

will be presented on July 10. In June, the Government had set up a committee to take a re-look at the

National List of Essential Medicines and the ambit of control is likely to rise. According to sources, the

number of drugs listed in this essential medicines list, which are brought under price control, is likely to

increase. According to a paper by the Associated Chambers of Commerce and Industry of India (As-

socham), the National Pharmaceutical Pricing Policy, 2012, has been misinterpreted by the National

Pharmaceutical Pricing Authority (NPPA) "causing undue hardships on the manufacturers." Bhaskar

Bhattacharya, Partner in Corporate Law Group, said that excess control can't be good for any of the

stakeholders. Further, Assocham also said India needs to reduce controls on producing raw materials for the

pharmaceutical industry, an Assocham study said on Friday. Over 60-70 per cent of active pharmaceutical

ingredients (APIs) are currently being imported from neighbour China due to the ingredients being cheaper.

This leading to massive decline in domestic production of the same, Umang Chatutvedi, global Head

(Corporate Affairs) of Ranbaxy, said. Further, this dependence has a strong relation to international

relations, the study notes, since "any deterioration in relationships with China can potentially result in

severe shortages in the supply of essential drugs to the country." Chaturvedi said that the Government could

look at setting up clusters for API manufacturers in order to help push up domestic production of these

important ingredients.

WILL BUDGET 2014 HELP LOCAL MEDICAL DEVICE MAKERS?


Given the government's stated commitment to encouraging manufacturing, it would be interesting to see

whether its first Budget addresses an obvious anomaly in how medical devices are taxed. As things stand,

the system is skewed heavily in favour of companies that import devices rather than those that manufacture

locally. Not surprisingly, about 80% of the medical devices market consists of imported devices, which

have added substantially to the cost of healthcare and, hence, to what patients have to shell out. While the

size of India's medical devices market is over Rs 30,000 crore, domestic device manufacturers say they are

struggling in the face of an adverse taxation regime policy. Currently, the import duty on medical devices

and instruments is about 10% and many are even duty-free. As the product is imported on a 'sale in the

course of import' basis, even value-added tax (VAT) is not applicable to these devices. On parts and

equipment imported for domestic manufacture of devices, however, there is customs duty plus excise and

VAT. This has meant a much higher effective tax on domestically produced products compared to imported

finished goods. This has led to dominant MNCs like GE and Siemens establishing factories in China and

importing finished goods into India. None of these companies have any manufacturing facilities in India as

there is no motivation for the multinationals to produce locally. "Countries like China, Brazil and Malaysia

differentiate between trading and manufacturing companies. Many of them like China also make product

registrations very difficult for trading-only companies to encourage local manufacturing. They had an

enlightened policy of starting off by allowing only joint ventures so that domestic partners could build their

capacity. That has helped China become the world's largest manufacturer of medical devices in volume,"

explained Dr G S K Velu, founder and MD, Trivitron Healthcare, an Indian medical technology company.

USFDA ENFORCEMENTS TO PUSH UP COSTS FOR INDIAN PHARMA


Stricter norms by American drugs regulator USFDA will lead to higher compliance costs for Indian pharma,

although these enforcements are not country specific but more on account of "cultural differences", said a

report by global credit rating agency Crisil. The companies have little choice but to invest in bringing

compliance processes up to speed, it said, adding that the cost of not doing so (warning letters/import alerts

may impact both current revenues and future pipeline) will be far higher. In general, the cost of compliance

of drug makers has doubled over the past 5 years. About 30 per cent - or USD 4 billion worth - of India's

pharma exports are to the US. India remains a location of significant importance to the FDA as it has the

largest number of FDA-approved drug- manufacturing plants with over 150 formulation facilities and is

also the second-largest pharmaceutical supplier to the US market in terms of volume of generic drugs. The

enforcements by US Food and Drug Administration over Indian pharma companies, though not country

specific, are mainly on account of issues such as cultural differences and attitude of employees, it said.

However, going forward, Crisil said it expects the cost of compliance to rise as drug makers adapt to a

stricter regime. This will include costs of hiring personnel and consultants, apart from investments in

upgrading facilities to GMP standards. It added: "While the ratio of enforcements to manufacturing bases is

lower in India compared with elsewhere, the enforcements in India have been clearly due to cultural

differences, attitude of employees, inadequate interpretation/ understanding, and absence of due process and

systems.

PATENTS

GLOBAL COS RELUCTANT TO INTRODUCE LATEST CANCER DRUGS DUE TO FEAR OF

PATENT INFRINGEMENT ALLEGATIONS: HCG CHIEF


pharma companies are reluctant to introduce the latest cancer drugs because they fear patent infringement

allegations from India. The stalling of clinical trials since January 2013 has also made access to advanced

cancer drugs impossible in the country, said Dr. BS Ajaikumar, chairman, Healthcare Global Enterprises

(HCG) which is India’s largest network chain of 27 dedicated cancer care centres in the country. The hostile

response from global pharma majors to boycott new cancer medicines into India ensues Novartis’ Gleevac

drug which lost its patent protection here. This has turned painful for the scores of cancer patients in the

country as they do not have access to the advanced targeted therapies. In this regard, HCG has made a

representation to the new government and its health minister Dr. Harsh Vardhan to take a look into the issue

and provide remedial measures at the earliest. It was at the conference of the Association of Surgical

Oncologists in the US where global drug majors told the HCG chief that India was no longer on their radar

for new cancer drugs. They were wary of the Union government as it did not comprehend innovation nor

valued the intellectual property rights but were more keen to protect its generic drug manufacturers. Unless

there is a relook by the government, only then India would be reconsidered, said Dr. Ajai during an

interaction with the media. The anti cancer drugs launched by global companies between 2012 and April

2014 which are not marketed in India are Ramucirumab by Eli lilly, Ibrutinib of Pharmacyclix,

Obinutuzumab, TDM1, Vismodeb and Pertuzumab by Genetech, Pomalidomide by Celegene, Afatinib by

Boerhirnger Ingelheim, Regorafinib, Radium and Regorafinib by Bayer, Dabratinib by GSK, Bosatinib,

Axitinib and Crizotinib by Pfizer, Ponatinib by Ariad Pharmaceuticals, Cartilzomib by Onyx, Liposomal

Vincristine by Talon, Cabozatinib by Exelixis, Enzulatamide by Mediavation, Aflibercept by Sanofi and

Brentuximab by Seattle Genetions, informed Dr. BJ Srinivas, consultant medical oncology, HCG adding

that these were for cancers of breast, lung, colorectal in adults and leukaemia in the paediatric population.

COLLEGIUM'S OXYCODONE DETERX FORMULATION RECEIVES US PATENT


The US Patent and Trademark Office (USPTO) has issued US patent No. 8,758,813 to Collegium

Pharmaceutical, Inc.. The patent relates to Collegium’s Oxycodone DETERx formulation and contains

claims that cover the company’s lead product, an abuse-deterrent, extended-release oxycodone product

utilizing its proprietary DETERx technology. Collegium currently has six US patents that are Orange Book

listable. All issued patents provide protection until 2025. Outside of the US, Collegium has three patents in

Japan, Australia and Canada. Oxycodone DETERx is currently in phase 3 clinical development and topline

data is anticipated in Q3 2014. The product has been designated Fast Track Status by the FDA. In addition

to the phase 3 study to establish the safety and efficacy of the product, Collegium has executed a

comprehensive development programme for evaluation of the product’s abuse-deterrent properties

consistent with FDA’s 2013 Draft Guidance, “Abuse-Deterrent Opioids - Evaluation and Labeling.” “The

newly issued patent strengthens and expands our patent coverage for Oxycodone DETERx, our lead

development product. We are continuing to focus on the prosecution of additional patents that support our

lead product and the DETERx technology in both the US and internationally,” states Michael Heffernan,

CEO of Collegium. The DETERx drug delivery platform consists of a multi-particulate matrix formulation

in a capsule. While developed primarily to provide abuse-deterrent properties to protect against common

methods of tampering such as chewing, crushing, insufflation and extraction for IV injection, the multi-

particulate design is expected to enable patients with difficulty swallowing to open the capsule and

administer the contents on food or via a gastrostomy tube, while maintaining the extended-release

properties of the product.

ACORDA THERAPEUTICS SUES ACTAVIS ON GENERIC AMPYRA PATENT


Actavis plc, has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug

Administration (US FDA) seeking approval to market dalfampridine extended-release tablets, 10 mg.

Actavis' ANDA product is a generic version of Acorda Therapeutics' Ampyra, which is indicated as a

treatment to improve walking in patients with multiple sclerosis. Acorda Therapeutics, Inc. filed suit against

Actavis on July 7, 2014, in the US District Court for the District of Delaware seeking to prevent Actavis

from commercialising its ANDA product prior to the expiration of certain US Patents. The lawsuit was filed

under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA

until July 22, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to

any other exclusivities. Based on available information, Actavis believes it may be a "first applicant" to file

an ANDA for the generic version of Ampyra and, should its ANDA be approved, may be entitled to 180

days of generic market exclusivity. For the 12 months ending April 30, 2014, Ampyra had total US sales of

approximately $231 million, according to IMS Health data.

PHARMALINK'S NEFECON FOR RENAL DISEASE RECEIVES US, EUROPE, CHINA &

HONG KONG PATENTS


AB, a Swedish specialty pharma company focussed on orphan and niche products, has had core patents for

its late-stage clinical candidate Nefecon issued in the key markets United States, Europe, China and Hong

Kong. A patent is pending in Japan. Nefecon is a potential disease-modifying treatment for patients with

primary IgA nephropathy at risk of developing end-stage renal disease. Nefecon has shown positive results

in an open-labelled phase II trial evaluating safety and efficacy and is now being tested in a placebo-

controlled randomised phase IIb study. Pharmalink recently completed patient enrolment of this study,

which has been designed to enable an optimal dose of Nefecon to be selected for a phase III registration

trial. Headline data is anticipated in Q3 2015. The patents issued in the US (US 8,491,932), Europe (EP

2278958) China (200980127272.5) and Hong Kong (1158510) provide protection around the formulation of

Nefecon and its use as a treatment of glomerulonephritis, including IgA nephropathy, the most common

form of primary glomerulonephritis and a cause of end-stage renal disease. The formulation technology,

TARGIT, was licenced by Pharmalink for exclusive use with Nefecon under a 2011 agreement with

Archimedes Development Ltd (UK). The suite of recently issued patents are the result of a very productive

formulation development partnership between the companies.

THE NEXT PATENT OFFICE DIRECTOR PROBABLY SHOULDN'T BE ONE OF THE GUYS

WHO KILLED PATENT REFORM

EFF, 7 July, 2014

Philip Johnson is Chief Intellectual Property Counsel of Johnson & Johnson, one of the largest

pharmaceutical companies in the world. He is also a representative member of the Coalition for 21st

Century Patent Reform, the leading trade group opposing patent reform this past year. And now

he'srumored to benext in line to be the director of the United States Patent and Trademark Office.

What?

That's exactly what we're asking ourselves. Why would an administration that has ostensibly been so pro-

reform over the last year nominate such an entrenched insider? (Though perhaps this isn't so shocking a

question, as those of us working on the net neutrality fight would remind ourselves.) Although it would

seem that Johnson is eminently qualified as a patent expert, many of his views lie contrary to recent reform

efforts—including reforms proposed by the White House itself. The Coalition for 21st Century Patent

Reform, or 21C, represents companiesin the pharmaceutical and biotech industries, among others. These

industries, flanked by trial lawyers and universities, helped water down and ultimately kill patent reform

this year. In fact, Johnson's employer, a member of 21C, was recently called out as leading the charge

against patent reform. For example, 21C worked to remove the expansion of covered business method

(CBM) patent review from proposed legislation [PDF], which is a big part of the reason why language

around such reform didn't appear in the final version of the House's Innovation Act nor the latest Senate

proposals. Johnson's perspective lies directly contrary to theWhite House's proposalin early 2013,

recommending that the legislature expand the CBM provision to include computer-enabled patents. The

latest versions of the Senate bill—known as the "Schumer-Cornyn Compromise"—contained solid language

about stays of discovery and heightened pleading, both of which 21C hadvigorously opposed [PDF]and

worked to remove.

POLICY AND REGULATIONS

JAITLEY PROMISES AFFORDABLE HEALTHCARE FOR ALL IN HIS MAIDEN BUDGET


its commitment to ensure high quality healthcare services to patients across the spectrum, the central

government has set apart Rs.5000 crore for the All India Institute of Medical Sciences (AIIMS). Apart from

that, the government also announced its decision to set up four new AIIMS in Andra Pradesh, West Bengal,

Maharashtra and Uttar Pradesh. From the allotted funds Rs.900 crore will be dedicated for each AIIMS to

be functional at the earliest. The government also informed that the six new AIIMS like institutions situated

in Bhopal, Patna, Jodhpur, Rishikesh, Raipur and Bhubaneswar have already started its functions and that in

the future they plan to add one AIIMS like institution in each of the states. While delivering his maiden

budget, finance minister Arun Jaitley announced that they will provide free drug and diagnostic services to

needy patients along with establishing 12 new government medical colleges plus dental facilities across the

country. To ensure availability of high quality drugs to the patients the Center will be providing funds to set

up new drugs and food testing labs across the country apart from supporting with funds to modernise and

technically upgrade the 31 existing labs. The Centre for the first time has decided to set up 15 new rural

healthcare regional centers to address the lacunae in addressing the healthcare needs of the patients in the

far-flung region of the country. With a view to inspire and encourage new entrepreneurs to take up good

projects, the government has set up a committee for MSME and has allocated Rs.10,000 crore for the same.

Further the FM promised to set up three dedicated biotechnology parks in Pune, Kolkatta and Mohali

through the public private partnership (PPP) route and stressed that there needs to be more PPP with private

and foreign institutes to encourage biotechnology in the country.

DRUG CONTROLLER GENERAL OF INDIA TO PHARMA MNCS: CONDUCT FRUITFUL

CLINICAL TRIALS FOR INDIANS


NEW DELHI: Multinational pharmaceutical companies keen to conduct clinical trials for new drugs on

Indians would have to ensure an early launch of those therapies in India if the trials result in commercial

production, the drug regulator has said. In an order issued last week, the Drug Controller General of India

(DCGI) said innovator drug firms would have to seek approval for such new drugs ( New Chemical Entities

and New Biological Entities) in India soon after obtaining marketing clearance in their respective countries.

The DCGI has directed drug firms to furnish an undertaking along with their application for clinical trials,

promising that once they manage a marketing clearance for the new therapy in their respective country or a

developed market, they would file for an approval in India and ensure the therapies are "marketed in India

speedily, preferably by production within the country". This is meant to expedite launch of cutting edge

therapies in the country, particularly in cases where India has participated during the trials. Of the total 140

newly discovered drugs that were launched between 2006 and 2010 globally, only 39 (28per cent) are

available in the Indian market. This gap between the number of new drugs launched globally and such

therapies introduced in India is the sharpest in the segment of cancer treatment, although the gap in other

therapies such as cardiovascular and neurology also remains significant, according to the database of IMS

Institute for Healthcare Informatics, a global pharma market research firm. This move is part of a series of

measures that the central drug regulator has taken last week to bring clarity in the clinical trials space and

ensure patients are not exploited. Among other steps, the DCGI has said that no investigator or physician

can conduct more than three trials at a time. Until now, there were no limits to the number of trials a

physician could undertake at a given time.

GOVERNMENT SIGNS PACT TO REVIVE INDIAN DRUGS AND PHARMACEUTICALS LTD,

TO PROVIDE NEED-BASED FUNDS


The government has agreed to provide funds on a need based basis to revive sick public sector

pharmaceutical undertaking Indian Drugs and Pharmaceuticals Ltd (IDPL). A Memorandum of

Understanding has been signed between Department of Pharmaceuticals and IDPL to make it a 'vibrant drug

manufacturing company', setting targets, including to achieve at least 5 per cent growth in sales and 5 per

cent reduction in inventory of finished goods over 2013-14. IDPL's sales turnover is estimated to be Rs 63

crore and a net loss of Rs 309.01 crore as on March 31, 2014. According to the MoU, the government

support is being provided with the aim to manufacture and supply essential medicines, and generic drugs

for supply to central and state government organisations and pharmacies at reasonable prices. It further said,

the other objective is to help meet the emergency needs of the country for supply of medicines during

natural calamities. As per the MoU, government support would also help to modernise, upgrade and

improve production facilities in tablet and capsule section at Rishikesh, Chennai and Gurgaon plants. Draft

Rehabilitation Scheme (DRS) for revival of IDPL has been submitted and cabinet note for revival is on

process. A action plan for implementation and monitoring of the MoU has also been signed under which

IDPL will monitor monthly and quarterly implementation of the pact, while Dept of Pharmaceuticals will

do the same for the half year.

BUDGET 2014: FREE DRUGS, DIAGNOSIS TO ENSURE 'HEALTH FOR ALL' PRIORITY:

GOVERNMENT


With an aim to ensure "Health for All," the Government today promised to take up on priority key health

initiatives of providing free drugs and free diagnostic services besides earmarking Rs 500 crore to set up

four more AIIMS-like institutes in the country. In his maiden budget speech, Finance Minister Arun Jaitley

said the government has also decided to set up 15 model rural health research centres in states for better

health care facilities in rural India. Jaitley said Rs 500 crore has been allocated for a plan to set up four

more AIIMS-like institutes in Andhra Pradesh, West Bengal, Vidarbha in Maharashtra and Poorvanchal in

Uttar Pradesh. The Minister also proposed to add 12 government medical colleges, where dental facilities

would also be provided. At present, 58 government medical colleges have been approved. "In order to

achieve universal access to early quality diagnosis and treatment to TB patients, two National Institutes of

Ageing will be set up at AIIMS, New Delhi and Madras Medical College, Chennai. A national level

research and referral Institute for higher dental studies would be set up in one of the existing dental

institutions," Jaitley said. For the first time, the Government will provide central assistance to strengthen the

States' Drug Regulatory and Food Regulatory Systems by creating new drug testing laboratories and

strengthening the 31 existing State laboratories, he said. "In keeping with the Government's focus on

improving affordable health care and to augment the transfer of technology for better health care facilities

in rural India, 15 Model Rural Health Research shall be set up in the states, which shall take up research on

local health issues concerning rural population," Jaitley said enumerating steps for the health sector in the

budget.

BUDGET 2014: HEALTHCARE SECTOR WELCOMES MOVE FOR MORE AIIMS IN INDIA


Healthcare industry today welcomed the government's plan to open more AIIMS-like institutions in the

country, saying it would bring down the cost of treatment. "Finance Minster's announcement of building 4

AIIMS (like) and 12 government medical colleges will help in bringing healthcare services cost down,"

industry body NATHEALTH Secretary General Anjan Bose said. Expressing similar views, Apollo

Hospitals Managing Director Suneeta Reddy said the proposals for 4 new AIIMS like institutions and

thereafter in every state in the coming years augured well from affordability perspective. This would also be

helped by the proposal to increase FDI to 49 per cent in insurance sector that "has a direct bearing on access

to overall coverage with healthcare being a critical subset", she added. Presenting the Budget for 2014-15,

Finance Minister Arun Jaitley said two key initiatives - free drug service and free diagnosis service - would

be taken up on priority as part of move towards 'Health for All'. Charting out the healthcare roadmap of the

new government, Jaitley said plans have been firmed up to set up four more AIIMS like institutions at

Andhra Pradesh, West Bengal, Vidarbha in Maharashtra and Poorvanchal in UP is under consideration and a

sum of Rs 500 crore has been set aside. Jaitley in his Budget speech today said the government will provide

central assistance to strengthen the States' Drug Regulatory and Food Regulatory Systems by creating new

drug testing laboratories and strengthening the 31 existing State laboratories. BD (Becton, Dickinson and

Co) India Managing Director Varun Khanna said setting up of state drug laboratories reflects the emphasis

on healthcare for the people.

BUDGET 2014: FREE DRUGS, DIAGNOSIS TO ENSURE 'HEALTH FOR ALL' PRIORITY,

SAYS GOVT


Aiming to ensure "Health for All," government today promised to take up on priority initiatives like

providing free drugs and diagnostic services besides earmarking Rs 500 crore to set up four more AIIMS-

like institutes and earmarked Rs 39,237.82 crore for the sector. In his maiden budget speech, Finance

Minister Arun Jaitley said the government has also decided to set up 15 model rural health research centres

in states for better healthcare facilities in rural India. Jaitley said Rs 500 crore has been allocated for a plan

to set up four more AIIMS-like institutes in Andhra Pradesh, West Bengal, Vidarbha in Maharashtra and

Poorvanchal in Uttar Pradesh. He also proposed to add 12 government medical colleges, where dental

facilities would also be provided. At present, 58 government medical colleges have been approved. The

allocation to the health sector was up by merely 5 per cent from Rs Rs 37,330 crore proposed in the last

budget by the previous Congress-led UPA government in the last budget. "In order to achieve universal

access to early quality diagnosis and treatment to TB patients, two National Institutes of Ageing will be set

up at AIIMS, New Delhi and Madras Medical College, Chennai. A national level research and referral

Institute for higher dental studies would be set up in one of the existing dental institutions," Jaitley said. Of

the total allocation for the health sector for 2013-14, the Department of Health and Family Welfare got the

major share of Rs 35,163 crore that includes Rs 30,645 Plan outlay. This is up from Rs 33,278 crore

proposed in the last budget that includes Rs 29,165 crore of Plan outlay. The Department of Ayush got an

outlay of Rs 1,272.15 crore (against Rs 1,259 crore in the last budget), the AIDS Control Rs 1,785 crore

(same as last year), and the department of Health Research Rs 1,017 crore, against 1,008 crore in the last

budget.

BUDGET 2014: PHARMA INDUSTRY'S EXPECTATIONS


OPPI represents the research-driven pharmaceutical companies in India and remains committed to

supporting the nation's healthcare objectives by collaborating with the Indian Government and other

stakeholders to find sustainable healthcare solutions. A holistic approach is needed to expand healthcare in

India and OPPI believes that there is a need to balance innovation with access and affordability, within a

robust IP environment. The BJP manifesto had laid out the vision of universal healthcare that is not only

accessible and affordable but also effective and reduces the OOP (out-of-pocket) spending for the common

man. In his Pre-Budget meeting with States and UT Finance Ministers, Mr Arun Jaitley, the Union Finance

Minister had also emphasised the importance of healthcare access and quality. He recognised that not only

do we need to improve healthcare access but also ensure a quantum jump in the quality of health services at

an affordable price. OPPI's pre-budget memorandum outlines the following expectations: 1. Weighted Tax

Deduction on Scientific Research The Department of Pharmaceuticals (DoP) envisages developing India as

a Drug Discovery and Pharma Innovation hub by capturing 15-20% of the world's R&D pipeline by 2020.

This will enable India to become one of the top five countries in the world in terms of drug discovery and

pharma innovation. R&D is a segment which can become a key enabler of growth for the Indian pharma

sector. To encourage investment in R&D, any expenditure related to research conducted in-house i.e.

clinical trials, bioequivalence studies, regulatory and patent approvals, should be eligible for weighted tax

deduction, even if these activities are outsourced. Currently there are no specific tax benefits available to

units engaged in contract R&D or undertaking R&D for group companies. Benefits should be provided for

units engaged in the business of R&D and contract R&D by way of deduction from profits. 2.

BUDGET 2014: RASHTRIYA SWASTHYA BIMA YOJANA MAY BE SHIFTED TO HEALTH

MINISTRY


With the aim of rolling out universal health coverage scheme in the country, the government is weighing the

possibility of shifting Rashtriya Swasthya Bima Yojana (RSBY), the largest medical insurance programme

globally which covers over 120 million poor people, from labour to health ministry. Pointing out that

universal health coverage is the mandate of the health ministry, a recent letter from the Prime Minister's

Office has sought an explanation from the labour ministry on why the RSBY programme should not be

transferred to the health ministry, government officials told ET. "The letter suggests that in many states, the

programme is already being implemented by the health departments," an official said, adding that the

performance of such states seems to be better. It further spoke of exploring the potential synergy between

RSBY and programmes currently run by the health ministry, he said. For instance, the IT system employed

in RSBY-empanelled hospitals which generates huge database of health records from across private and

public hospitals can help the health ministry detect early outbreak of diseases and aid schemes like

integrated disease surveillance programme (IDSP). The health ministry is refining its own health

management information system, and integrating it with RSBY's IT system, which could yield a more

robust system. Other tools enlisted by RSBY can help schemes like Janani Suraksha Yojana ( JSY), track

health of mothers and infants better and improve immunisation programmes. The health ministry, on its

part, has set up an expert committee to prepare the broad road map for universal healthcare coverage, which

also counts among its members key government officials from the labour ministry involved in running the

RSBY. The evidence from different states in implementing the RSBY indicates that wherever the

programme was expanded to cover more population or more diseases, health departments were the nodal

agencies.

EU BODY IMPOSES $583-M FINE ON DRUGMAKERS


European Union antitrust regulators fined French drugmakerServier, Israel's Teva and four others a total of

428 million euros ($583 million) on Wednesday for blocking cheaper generic medicine. The sanctions are

the third by the European Commission against so-called pay-for-delay deals in the pharmaceutical industry.

European competition commissioner Joaquin Almunia said, "Servier had a strategy to systematically buy

out any competitive threats... Such behaviour is clearly anti-competitive and abusive."

BUDGET 2014: MAKE HEALTH INSURANCE MORE ACCESSIBLE AND AFFORDABLE FOR

ALL


With a new, stable government at the center, we hope for an impetus towards a higher growth trajectory for

the health insurance sector and to make health insurance more accessible and affordable for all. The first

step that the Government could take immediately would be to increase the tax exemption limit under

Section 80D from Rs 15,000 to Rs 25,000 for individuals and an additional Rs 25,000 for parents (Rs

30,000 for parents who are senior citizens). This would ensure families have the much needed financial

means to keep a check on their current health status. Secondly, we believe the new government can

encourage people by increasing the tax rebate from Rs 5,000 available for preventive checkups to a

minimum of Rs 10,000 and make it additional to the rebate one gets for the health insurance premium paid.

Timely diagnosis of ailments would work a long way to prevent people from having a financial burden due

to critical illnesses and hospitalisation. Thirdly, we request that the service tax paid on health insurance is

removed for the common man to make it more affordable for all. Finally, we look forward to the clearance

of the long pending 'The Insurance Laws (Amendment) Bill, 2008' this year, which will enable insurance

companies to avail of increased foreign direct investment (FDI) from the current ceiling of 26 per cent.

Opening up the insurance sector for FDI investment will encourage the entry of foreign processes and big

data analyses that would benefit Indian insurance companies.

BUDGET 2014: MODI GOVT SHOULD INCREASE HEALTHCARE SPENDS TO 5% OF GDP


All inclusive development in Pharma Biotech will lead to expansion, thus creation of jobs If there is one

thing that the Pharma Biotech segment wants from the Narendra Modi government it is 'an all-inclusive

development that goes beyond social dimensions'. Such a program is expected to trigger a spate of

expansions leading to creation of jobs. The domestic Pharma segment is estimated to reach US $49 billion

by 2020, and the projected human resource requirement to match this growth is estimated to be about

21,50,000 by 2020, according to the India Brand Equity Foundation(IBEF). To reach this level of

development industry experts are suggesting several specific steps. "Over the next five years healthcare

spends should increase to at least 5 per cent of the GDP - which still is very low as compared to the

developed nations. Major revamping of the healthcare infrastructure is needed which includes upgrading

and focusing on the primary healthcare systems and reaching out to the rural masses of the country. Major

stress on preventive healthcare like clean drinking water, toilets, vaccination, prenatal-perinatal care and

reduction of infant and maternal mortality rates rather than curative healthcare," says Dr. Sudarshan Ballal,

medical director & chairman, Medical Advisory Board, Manipal Health Enterprises. This is expected to

address the issue of acute shortage of nursing, para-medical personnel and doctors both at the MBBS and

PG level.

PRODUCT APPROVALS

GLENMARK'S TELMISARTAN TABLETS RECEIVES US FDA APPROVAL


Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited, has been granted final

abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA)

for telmisartan tablets. Glenmark will commence distribution of the product immediately. Telmisartan

tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis. Telmisartan is indicated for the

treatment of hypertension. The approval is for the 20mg, 40mg and 80mg tablets. For the 12 month period

ending March 2014, telmisartan garnered annual sales of USD 250 million according to IMS Health.

Glenmark’s current portfolio consists of 92 products authorized for distribution in the US marketplace and

73 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to

identify and explore external development partnerships to supplement and accelerate the growth of the

existing pipeline and portfolio.

PERRIGO GETS US FDA APPROVAL FOR STORE BRAND EQUIVALENT TO ADVIL

CONGESTION RELIEF TABLETS


The US Food and Drug Administration (FDA) has granted final approval to Perrigo Company's abbreviated

new drug application for ibuprofen and phenylephrine hydrochloride tablets, 200 mg/10 mg (over-the-

counter), the store brand equivalent to Advil Congestion Relief Tablets, 200 mg/10 mg. Perrigo expects to

begin shipments of the product prior to the upcoming cough/cold/flu season. Advil Congestion Relief

Tablets, 200 mg/10 mg, (ibuprofen & phenylephrine hydrochloride tablets, 200 mg/10 mg) is indicated for

the relief of sinus pressure, nasal swelling and congestion, and headache. Estimated annual sales of the

product are approximately $18 million. Perrigo's chairman, president and chief executive officer, Joseph C.

Papa stated, "This approval further strengthens our leading store brand position and highlights our

commitment to bringing new affordable products to the market."

EAGLE PHARMA GETS US FDA TENTATIVE NOD FOR PATENTED, READY-TO-DILUTE

BENDAMUSTINE HCL INJECTION


The United States Food and Drug Administration (FDA) has granted tentative approval to Eagle

Pharmaceuticals' New Drug Application (NDA) for patented bendamustine hydrochloride injection, a

ready-to-dilute concentrate solution (bendamustine RTD) for the treatment of Indolent B-cell non-Hodgkin

lymphoma (NHL). "Tentative approval" means that FDA has concluded that a drug product has met all

required quality, safety and efficacy standards, but is not eligible for marketing in the US because of

existing patent protections or exclusivities. The tentative approval will convert to a final approval subject to

the resolution of the current patent litigation on-going between Eagle and Teva Pharmaceutical Industries

Ltd. (Teva), and the resolution or expiry of certain Orphan Drug exclusivities held by Teva. “We are pleased

to have achieved this critical milestone for our improved bendamustine RTD formulation, which we believe

will benefit patients and healthcare providers alike,” stated Scott Tarriff, president and chief executive

officer.

GSK’S ANORO ELLIPTA RECEIVES JAPANESE APPROVAL FOR COPD TREATMENTS


The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved GlaxoSmithKline’s Anoro

Ellipta (umeclidinium/vilanterol) for the relief of various symptoms due to airway obstruction with chronic

obstructive pulmonary diseases (chronic bronchitis, pulmonary emphysema) (in the case where concurrent

use of long-acting inhaled muscarinic antagonist and long-acting inhaled beta2 agonist is required). Anoro

is a once-daily combination treatment comprised of two bronchodilators, umeclidinium (UMEC), a long-

acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single

inhaler, the Ellipta. The approved dose in Japan is UMEC/VI 62.5/25mcg delivered once daily.

BRISTOL-MYERS' FIRST ALL-ORAL, INTERFERON- AND RIBAVIRIN-FREE HEP C

TREATMENT, DAKLINZA+SUNVEPRA DUAL REGIMEN GETS JAPANESE NOD


The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Bristol-Myers Squibb's

Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra

(asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many

patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is

Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic

hepatitis C virus (HCV) infection, including those with compensated cirrhosis. “Japan has a unique hepatitis

C patient population, many of whom are older and have been unable to take, or respond to, traditional

therapies, so we have a real sense of urgency to treat these patients now,” said a lead study investigator

Kazuaki Chayama of Hiroshima University in Japan. “The approval of the Daklinza+Sunvepra Dual

Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV

patients.” Of the 1.2 million people living with HCV in Japan, approximately 70% have genotype 1b.

Further, a significant number of patients with HCV in Japan are over the age of 65, leading to more disease-

related complications and a decreased likelihood of tolerating interferon-based therapies, the historical

standard of care for treating HCV. “The approval of Daklinza+Sunvepra in Japan reflects our strategic focus

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on developing a treatment option that meets the needs of the Japanese HCV patient population,” said

Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb.

GLENMARK TO LAUNCH ANTI-HYPERTENSION DRUG IN US, GETS USFDA NOD


Glenmark Pharmaceuticals will launch generic version of anti-hypertension drug telmisartan tablets in the

US market following receipt of approval from the country's health regulator. Glenmark Generics Inc., USA

a subsidiary of Glenmark Generics Ltd has been granted final abbreviated new drug approval ( ANDA)

from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets, the company said

in a filing to the BSE. "Glenmark will commence distribution of the product immediately," it added. The

approval is for the 20 mg, 40 mg and 80 mg tablets. Telmisartan tablets are Glenmark's generic version of

Boehringer Ingelheim's Micardis. Telmisartan is indicated for the treatment of hypertension. For the 12-

month period ended March 2014, Telmisartan garnered annual sales of USD 250 million, according to IMS

Health, the company said. Glenmark's current portfolio consists of 92 products authorised for distribution in

the US market and 73 ANDAs are pending approval with the USFDA. Shares of Glenmark Pharmaceuticals

were trading at Rs 595.60 per scrip in the mid-day trade, up 1.09 per cent from the previous close on the

BSE.

SPECTRUM GETS US FDA ACCELERATED APPROVAL OF BELEODAQ TO TREAT

PATIENTS WITH RELAPSED/REFRACTORY PTCL


Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug

development operations with a primary focus in hematology and oncology, announced that the US Food and

Drug Administration (US FDA) has granted Accelerated Approval of Beleodaq for the treatment of patients

with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under

accelerated approval based on Tumour Response Rate and Duration of Response. An improvement in

survival or disease-related symptoms has not been established. Continued approval for this indication may

be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq was

approved by the FDA on July 3rd, nearly 5 weeks before the PDUFA date (August 9th). This indication was

approved based on data from the multi-centre, single-arm BELIEF trial in 120 evaluable patients, refractory

to or who had failed at least one prior systemic therapy. In this trial, Beleodaq was associated with

hematologic toxicity, infections, hepatotoxicity, Tumour lysis syndrome, gastrointestinal toxicity, and

embryo-fetal toxicity. PTCL comprises a group of rare and aggressive non-Hodgkin's Lymphomas (NHL)

that develop from mature T-cells and accounts for approximately 10 to 15per cent of all NHL cases in the

United States. These patients generally have a poor prognosis with a low response rate (25-27per cent) to

available treatment options, and commonly experience repeated treatment failures until drug resistance or

death. Therefore, there has been an important unmet medical need for these patients with PTCL for

additional new treatment options that are specifically effective for this disease.

NOVO NORDISK'S NOVOSEVEN RT RECEIVES US FDA APPROVAL TO TREAT

GLANZMANN'S THROMBASTHENIA WITH REFRACTORINESS


The US Food and Drug Administration (US FDA) has approved Novo Nordisk's NovoSeven RT

(Coagulation Factor VIIa [Recombinant]) as the first recombinant treatment for bleeding episodes and

perioperative management in patients with Glanzmann's Thrombasthenia (GT) with refractoriness to

platelet transfusions, with or without antibodies to platelets. Glanzmann's Thrombasthenia is a rare genetic

bleeding disorder with limited treatment options. The safety and effectiveness of NovoSeven RT were

demonstrated in the treatment of severe bleeding episodes and the perioperative management for major and

minor surgical procedures for this specific patient population. Patients with GT have a lifelong

susceptibility toward bleeding episodes, including frequent, severe, and potentially life-threatening

hemorrhages.

MYLAN LAUNCHES TELMISARTAN TABLETS IN US MARKET


Inc., a global pharmaceutical company, has launched telmisartan tablets USP, 20 mg, 40 mg and 80 mg, the

generic version of Boehringer Ingelheim's Micardis tablets. Mylan received final approval from the US

Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product,

which is indicated for the treatment of hypertension, to lower blood pressure. Telmisartan tablets USP, 20

mg, 40 mg and 80 mg, had US sales of approximately $259.2 million for the 12 months ending March 31,

2014, according to IMS Health.

ROCHE’S ALECTINIB RECEIVES JAPANESE APPROVAL TO TREAT PEOPLE WITH

ADVANCED LUNG CANCER


The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Roche's alectinib for the

treatment of people living with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase

fusion gene-positive (ALK+). The approval was based on results from a Japanese phase I/II clinical study

(AF-001JP) for people whose tumours were advanced, recurrent or could not be removed completely

through surgery (unresectable). “The approval of alectinib, a treatment specifically targeted to ALK+ lung

cancer, in Japan is great news for people living with this difficult to treat disease,” said Sandra Horning

MD, Roche’s chief medical officer and ead of global product development. “Another interesting aspect of

alectinib is that based on early studies it may also work in people living with tumours that have spread to

the brain, a difficult area to reach with current medicines. Our research will continue in this area." Alectinib

is expected to be made available in Japan later this year. Alectinib was also granted Breakthrough Therapy

Designation (BTD) by the US Food and Drug Administration (US FDA) in June 2013 for patients with

ALK+ NSCLC who progressed on crizotinib. BTD is designed to expedite the development and review of

medicines intended to treat serious diseases and to help ensure patients have access to them through FDA

approval as soon as possible. Global pivotal studies are currently ongoing which will further inform on the

clinical value of alectinib in this disease setting as well as in treatment-naïve patients. The results of these

studies will be used in future regulatory submissions in the US and in Europe. This trial was conducted in

13 medical institutions in ALK fusion gene positive recurrent or advanced non-small cell lung cancer

patients with a treatment history of one or more chemotherapy regimens. The trial consisted of two phases:

Phase I that evaluated safety, tolerability, pharmacokinetic parameters and recommended dose (24 patients),

and a Phase II part that evaluated the efficacy and safety of the recommended dose (46 patients). The

primary endpoint was response rate. Japanese Phase I/II study (AF-001JP) results. The Phase I part of the

study determined a recommended dose of 300 mg twice daily. No dose limiting toxicity was observed. The

Phase II portion of the study was conducted using the recommended dose, and demonstrated a response rate

of 93.5% (43/46 patients; 95%CI: 82.1-98.6%).

GRUNENTHAL GROUP, AN INDEPENDENT, FAMILY-OWNED, INTERNATIONAL

RESEARCH-BASED PHARMACEUTICAL COMPANY, HAS SUBMITTED A MARKETING

AUTHORISATION APPLICATION (MAA) TO THE EUROPEAN MEDICINES AUTHORITY

FOR ZALVISO FOR THE MANAGEMENT


The European Commission (EC) has granted marketing authorisation for GlaxoSmithKline’s Mekinist

(trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma

with a BRAF V600 mutation. Trametinib has not demonstrated clinical activity in patients who have

progressed on a prior BRAF inhibitor therapy. Before taking trametinib, patients must have confirmation of

a BRAF V600 mutation using a validated test. Trametinib is a MEK inhibitor which blocks the activity of a

protein kinase called MEK. This protein is present in the MAPK pathway, which regulates the normal

growth and death of cells and plays a role in metastatic melanoma development. Some mutations in the

BRAF gene can cause the MEK protein to stimulate cancer cell growth and survival; therefore, inhibiting

MEK can potentially slow down the growth of tumours in BRAF-mutant metastatic melanoma.

CLINICAL TRIALS

ONCOLYTICS COMPLETES PATIENT ENROLLMENT IN US RANDOMIZED PHASE II

PANCREATIC CANCER STUDY


Biotech Inc. (Oncolytics), a biotechnology company focused on the development of oncolytic viruses as

potential cancer therapeutics, has completed the patient enrollment in a two-arm randomized phase II study

of carboplatin, paclitaxel plus Reolysin versus carboplatin and paclitaxel alone in the first line treatment of

patients with recurrent or metastatic pancreatic cancer (OSU-10045). The principal investigator is Tanios

Bekaii-Saab, MD, associate professor and gastrointestinal oncology section chief at The Ohio State

University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove

Research Institute (OSUCCC - James). The trial is sponsored by the U.S. National Cancer Institute (NCI)

through a clinical trials agreement between the Cancer Therapy Evaluation Program, Division of Cancer

Treatment and Diagnosis and Oncolytics. Oncolytics is providing clinical supplies of Reolysin for the study.

"This is the second randomized study utilizing REOLYSIN to complete enrollment," said Dr. Brad

Thompson, president and CEO of Oncolytics. "This is an important study given the relatively limited

treatment options and generally poor prognosis for pancreatic cancer patients, who are often not diagnosed

until the more advanced stages of the disease." The study is an open-label, multi-institution, two-arm phase

II randomized study of patients with metastatic pancreatic cancer. Patients were randomized to receive

either carboplatin, paclitaxel plus Reolysin (Arm A) or carboplatin and paclitaxel alone (Arm B). Patients in

both arms received treatment every three weeks (21-day cycles) and standard intravenous doses of

paclitaxel and carboplatin on day one only. In Arm A, patients also received intravenous Reolysin at a dose

of 3x1010 TCID50 on days one through five. Tumor response assessment was done by computed

tomography (CT) scan and conducted every eight weeks. Patients who progressed on carboplatin and

paclitaxel (Arm B) had Reolysin added. If patients experienced significant toxicity related to carboplatin

and/or paclitaxel, they could continue with single agent Reolysin.

ENDO, BDSI ANNOUNCE POSITIVE RESULTS FROM PHASE III TRIAL OF BEMA

BUPRENORPHINE IN OPIOID-EXPERIENCED PATIENTS WITH CHRONIC PAIN


Endo Pharmaceuticals Inc., a subsidiary of Endo International plc, and BioDelivery Sciences International,

Inc. (BDSI) announced positive top-line results from its pivotal phase III efficacy study of BEMA

buprenorphine in opioid-experienced patients. BEMA buprenorphine is being developed for the

management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for

which alternative treatment options are inadequate in both patients who are opioid naive and opioid

experienced. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA

buprenorphine resulted in significantly (p<0.0001) improved chronic pain relief compared to placebo.

Additional secondary endpoints were supportive of the efficacy of BEMA buprenorphine compared to

placebo. The most commonly reported adverse events in patients treated with buprenorphine compared to

placebo were nausea (7.5% vs. 7.4%) and vomiting (5.5% vs. 2.3%). "We are highly encouraged by today's

announced study results, which we believe are meaningful for appropriate patients requiring an opioid,"

said Dr. Susan Hall, executive vice president, chief scientific officer and global head of research and

development and quality. "And we look forward to now focusing on our upcoming pre-NDA meeting this

month with FDA followed by the preparation and submission of our NDA for BEMA buprenorphine as

soon as possible." "We are extremely pleased with this robust and significant outcome from this trial in

opioid-experienced patients and look forward to sharing more of the results from this study and the positive

results from the earlier opioid-naive study at upcoming medical conferences," said Dr. Mark A. Sirgo,

president and CEO of BDSI. "In addition, the locking of the database for the opioid-experienced study has

triggered a $10 million milestone payment from Endo per our licensing agreement. We look forward to

working with Endo toward the completion of the NDA."

ADDEX THERAPEUTICS ANNOUNCES POSITIVE RESULTS FROM ADX71441 TO TREAT

NICOTINE ADDICTION


Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and

development, announced positive results with ADX71441 (GABAB receptor positive allosteric modulator)

in preclinical models of nicotine addiction. The results were generated as part of an ongoing research

collaboration with the United States National Institute for Drug Abuse (NIDA). The study with ADX71441

examined its effects on mecamylamine precipitated physical and affective withdrawal signs in mice

rendered dependent on chronic nicotine. The study was conducted as described by Jackson et al. (2008).

Compared to saline-infused mice, nicotine-withdrawn mice showed a significant increased anxiety-related

response, a significant increase in somatic signs and significant hyperalgesia compared to vehicle controls.

Oral treatment with ADX71441 at 1, 3 and 10 mg/kg administered 60 minutes prior to the precipitant,

mecamylamine, dose-dependently reversed the somatic signs of withdrawal in nicotine-dependent mice.

ADX71441 also reversed hyperalgesia at the highest dose of 10 mg/kg. The highest dose of ADX71441

alone did not precipitate withdrawal anxiety-like behaviour, somatic signs or hyperalgesia in saline-treated

mice. Overall these data indicate that ADX71441 could alleviate the physical signs associated with nicotine

withdrawal and help patients to achieve smoking cessation. A recent article by Filip in Neuropharmacology

(2014) reviews the therapeutic benefits in cocaine, nicotine, amphetamine and alcohol dependence of

GABAB PAMs further supporting the emerging role of GABAB activation as a strategy to achieve smoking

cessation. "These data are very promising and combined with data already generated using ADX71441 in

other addiction models, strongly supports the development of ADX71441 in addiction", said Sonia Poli,

chief scientific officer of Addex. "We thank NIDA and their team for the great work they have done and

look forward to continuing our collaboration." "Our collaboration with NIDA has provided invaluable

information for the further development of ADX71441 in addiction, and an excellent example of our

strategy to collaborate with government organisations, academia and patient groups to continue the

development of our portfolio of drug candidates." said Tim Dyer, chief executive officer of Addex.

Scientific advances have revolutionised our understanding of addiction as a chronic, relapsing disease and

not a moral failure.

NOVARTIS RELEASES NEW GLOBAL GUIDELINES FOR INVESTIGATOR INITIATED

TRIALS


Novartis released new global guidelines for Investigator Initiated Trials (IITs). Novartis has a strong history

of supporting the funding of Investigator Initiated Trials (IITs) governed by internal operating processes and

governance measures. Novartis defines IITs as studies developed and sponsored by an independent

investigator or academic sponsor. Clinical research undertaken through IITs must be based on the need to

address meaningful scientific and/or clinical objectives supported by valid scientific designs while

respecting the privacy rights, safety and welfare of patients. An IIT may be a clinical or non-clinical study

and is conducted without the participation of Novartis, where the sponsor of the IIT makes a request to

Novartis to provide either funding, drug product or both. For these IITs, Novartis provides financial support

and /or drug product according to a written agreement, which requires that third-party sponsors comply with

applicable local laws and regulatory requirements.

BEIGENE BEGINS PHASE 1 STUDY OF BGB-290 TO TREAT CANCER


BeiGene Co, Ltd., an innovative oncology company focussed on developing targeted and immune-oncology

therapeutics, has dosed the first patient in a phase 1 study of BGB-290 for the treatment of cancer. BGB-

290 is an investigational, oral, selective and potent inhibitor of poly (ADP-ribose) polymerase (PARP), an

enzyme family which is involved in a number of cellular processes, including DNA repair and programmed

cell death. BGB-290 is the second compound in BeiGene’s two-asset collaboration with Merck, which was

established in 2013 with the goal of leveraging Merck’s global oncology development and

commercialisation expertise. The first compound, BGB-283, an investigational second-generation B-RAF

inhibitor, entered a phase 1 study in November 2013. “We are excited to begin dosing in the first-in-human

trial of BGB-290, which we believe has the potential to be a new and better PARP inhibitor option for the

treatment of cancer,” said John V Oyler, chief executive officer, of BeiGene. “We continue to execute on

our clinical plan through this strategic collaboration with Merck as we advance both compounds through

the clinic and work toward our mission of developing life-saving cancer therapeutics to treat the unmet

medical needs of cancer patients”.

G-TREEBNT PLANS TO FILE IND FOR PHASE III TRIAL WITH RGN-259 IN PATIENTS

WITH MODERATE TO SEVERE DRY EYE


RegeneRx Biopharmaceuticals, Inc, and G-treeBNT Co. Ltd, a Korean biotech firm, jointly announced that

G-treeBNT is preparing to file an IND and sponsor a phase III clinical trial with RGN-259 (a Thymosin

Beta 4–based preservative-free eye drop) in patients with moderate to severe dry eye initially in South

Korea, followed by Japan and Australia, with follow-on registrations in certain additional Asian and Pacific

Rim countries if appropriate. The proposed phase lll trial is based on data generated in a 72-patient, double-

masked, placebo-controlled trial sponsored by RegeneRx and conducted by Ora, Inc., an ophthalmic CRO

in the US and Japan, as well as data generated in a recently completed 9-patient physician-sponsored,

double-masked, placebo-controlled clinical trial in patients with severe dry-eye syndrome, both conducted

in the US. Both phase II trials resulted in statistically significant sign and symptom improvements in central

cornea staining and ocular discomfort. RGN-259 is a sterile, preservative-free topical eye drop for

ophthalmic indications. Based on two phase II clinical trials in moderate and severe dry eye syndrome,

RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry

eye, as well as positive trends in other outcome measures.

JDRF TO PROVIDE FUNDING FOR LEXICON PHARMA'S PHASE 2 TRIAL OF LX4211 IN

TYPE 1 DIABETES


Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on developing breakthrough

treatments for human disease, announced that JDRF, the world's largest non-profit supporter of type 1

diabetes (T1D) research, will provide funding to support a phase 2, randomized, double-masked, placebo-

controlled clinical trial to evaluate the efficacy and safety of LX4211 in a younger population with T1D. Up

to 76 individuals with T1D, younger than 30 years of age and with HbA1c levels greater than 9.0%, are

expected to be randomly assigned to receive either placebo or a once daily 400mg dose of LX4211 and

complete the 12-week treatment period. The primary objective of this study is to demonstrate the

superiority of LX4211 versus placebo as adjunct to insulin treatment on HbA1c reduction at 12 weeks as

well as several secondary endpoints, including reduced variability in blood glucose levels and lower insulin

needs. "JDRF has a strategic T1D research plan designed to deliver a sustained stream of new life-changing

therapies, so we are pleased to collaborate with Lexicon on the development of LX4211 in T1D," said

Sanjoy Dutta, Ph.D., JDRF's assistant vice president, translational development. "This collaboration is part

of JDRF's Glucose Control Research Program whose goal is to develop and deliver improved insulin and

non-insulin adjunct therapies that progressively improve glucose and overall metabolic control in

individuals with T1D. We believe that LX4211's dual SGLT1/SGLT2 inhibitory mechanism offers an

innovative and exciting opportunity to deliver on this goal and address an important unmet medical need in

those with T1D struggling to achieve optimal glucose control target levels." "The results from our previous

phase 2 study of LX4211 in type 1 diabetes have encouraged us to also explore its potential application in

this younger population for whom managing glucose variability is an especially difficult challenge and in

which the significant majority are unable to achieve HbA1c targets," said Pablo Lapuerta, M.D., Lexicon's

executive vice president and chief medical officer.

RESEARCH

MEDTRONIC STUDY SHOWS PEOPLE WITH TYPE 2 DIABETES ACHIEVE SUPERIOR

OUTCOMES WITH INSULIN PUMPS VS MULTIPLE DAILY INJECTIONS


Medtronic, Inc announced the results of the OpT2mise trial, which showed that MiniMed insulin pumps

safely achieve better glucose control for people with insulin-requiring type 2 diabetes than multiple daily

injections. While the benefits of insulin pump therapy for people with type 1 diabetes are well proven, this

is the largest global study to evaluate the comparative efficacy of insulin pump therapy versus multiple

daily insulin injections in people with type 2 diabetes with poor glycemic control. Study results were

published online in The Lancet today. In the OpT2mise trial, those using insulin pumps achieved a mean

A1C (average blood glucose) reduction of 1.1 per cent compared to only a 0.4 per cent reduction by those

using multiple daily injections. This improvement in glucose control was achieved without any episodes of

severe hypoglycemia. In addition, those in the insulin pump group lowered the total daily dose of insulin by

more than 20 per cent. There was no difference in weight gain between the two groups. Reducing A1C is

critical for people with diabetes because even small percent drops aid significantly in preventing

complications such as eye disease, kidney disease, nerve damage and heart attacks[1],[2] "Many patients

with type 2 diabetes are failing to reach glycemic control despite using intense pharmaceutical regimens

including insulin via multiple daily injections. This patient population is sizeable and difficult to manage,

which frequently results in costly complications. For these patients, insulin pumps are an essential new

treatment option and have now scientifically been proven to show significant benefits," said Prof. Yves

Reznik from the University Hospital of Caen, France. "These trial results are important in showing that

insulin pump therapy can safely reduce A1C without causing hypoglycemic episodes and could redefine the

standard of care for the growing population of insulin-requiring type 2 diabetes patients." Approximately 20

million people around the world with type 2 diabetes require insulin replacement therapy and adherence to

insulin therapy can be a challenge, with 57 percent of patients on multiple daily injection (MDI) therapy

admitting to omitting insulin injections.

NIH FUNDED STUDY REVEALS HIGHER CELIAC RISK IN SWEDEN


More than one quarter of children with two copies of a high-risk variant in a specific group of genes

develop an early sign of celiac disease called celiac disease autoimmunity (CDA) by age 5. The findings are

from The Environmental Determinants of Diabetes in Youth consortium, or TEDDY External Web Site

Policy. The National Institutes of Health-funded study, published July 2 in the New England Journal of

Medicine External Web Site Policy, also found that participants in Sweden had higher rates of celiac disease

than participants in the United States, Finland and Germany, even with the same genetic risks. TEDDY is

studying celiac disease and type 1 diabetes because both are autoimmune diseases with some of the same

genetic risk factors. Celiac disease occurs in just under 1 percent of the U.S. population, and is more

common than type 1 diabetes. Celiac disease stems from an immune reaction to gluten, a protein found in

wheat, rye and barley. Over time, celiac disease can damage the small intestine and cause other health

problems. People with celiac disease and CDA need to follow a gluten-free diet. “By looking at the genes of

the children who participated in TEDDY, we can now identify who among them is at highest risk for celiac

disease, and their parents and health care providers can monitor these children to detect the disease early,”

said Beena Akolkar, Ph.D., project scientist for TEDDY at the NIH’s National Institute of Diabetes and

Digestive and Kidney Diseases (NIDDK). NIDDK is the primary funder of TEDDY. Researchers found that

youth with two copies of HLA-DR3-DQ2 had the highest likelihood of disease development by age 5. Of

this group, 26 percent developed CDA by age 5 and 12 percent developed celiac disease. In those with one

copy of HLA-DR3-DQ2, the risks of CDA and celiac disease by age 5 were 11 percent and 3 percent,

respectively. About 90 percent of celiac disease patients carry HLA-DR3-DQ2. Based on earlier research,

scientists expected to find lower rates of CDA and celiac disease in the United States and Germany than in

Sweden. Rates of CDA in Sweden were nearly double the U.S. rates. However, the researchers were

surprised to discover that Sweden also had higher rates of CDA and celiac disease than Finland. TEDDY

researchers next plan to look at factors including interaction between genes and the environment, including

examining how diet affects bacteria in the gut and the immune system of children with differing genetic

risks.

STUDY REVEALS GENE CRITICAL TO EARLY DEVELOPMENT OF CILIA


at the National Eye Institute (NEI) have described the functions of a gene responsible for anchoring cilia

sensory hair-like extensions present on almost every cell of the body. They show in a mouse model that

without the gene Cc2d2a, cilia throughout the body failed to grow, and the mice died during the embryonic

stage. The finding adds to an expanding body of knowledge about ciliopathies, a class of genetic disorders

that result from defects in the structure or function of cilia. NEI is part of the National Institutes of Health.

The findings are published in the online journal Nature Communications. Senior author Anand Swaroop,

Ph.D., is chief of the NEI laboratory of Neurobiology-Neurodegeneration and Repair. Lead author Shobi

Veleri, Ph.D., is a research fellow in the laboratory. Cilia are responsible for cell communication and play a

key role in the receptor cells of sensory systems. For example, they are essential for odor detection in the

nose and light reception in the eye. Because cilia are such a key element of cells, defects in genes that are

involved in cilia development or function can cause complicated syndromes involving multiple organs and

tissues. Bardet-Biedl and Joubert syndromes are examples of ciliopathies with symptoms that include

deafness, kidney disease, and degeneration of the retina. Meckel syndrome is a ciliopathy so dangerous

babies with the genetic defect rarely make it to term. On individual cells, cilia grow from the basal body, a

circular dent on the outer membrane acting as a platform. Supporting structures called distal and subdistal

appendages, which are like the flying buttresses supporting Notre Dame Cathedral, anchor the platform in

the basal body, priming it for the growth of cilia. Once anchored, the structures that form the cilium begin to

extend from the site. Inside are a variety of proteins essential to maintain the cilium. Cc2d2a is believed to

make a structural protein needed for cilia growth, but its precise functions have been unclear.

NIH SUPPORTS SCIENTISTS TO CONDUCT RESEARCH ON GENETIC UNDERPINNINGS OF

ALZHEIMER’S DISEASE


A team of scientists will use support from the National Institutes of Health (NIH) to conduct research into

the genetic underpinnings of Alzheimer’s disease, analysing how genome sequences the order of chemical

letters in a cell’s DNA may contribute to increased risk or protect against the disease. The NIH awarded

grants for using innovative new technologies and computational methods for the analysis. The scientists

also will seek insights into why some people with known risks do not develop the disease. The awards,

expected to total $24 million over four years, go to eight academic medical centers that have been at the

forefront of research in Alzheimer’s genetics: University of Pennsylvania, Philadelphia; Case Western

Reserve University, Cleveland; University of Miami; Columbia University, New York City; Boston

University; University of Washington, Seattle; Washington University in St. Louis, and University of Texas,

Houston. The investigators will analyse the genome sequencing data generated during the first phase of the

Alzheimer’s Disease Sequencing Project (ADSP), an innovative collaboration that began in 2012 between

the National Institute on Aging (NIA) and the National Human Genome Research Institute (NHGRI), both

part of NIH. The first phase of the project determined the order of all 3 billion letters in the individual

genomes of 580 participants. It also generated whole exome sequencing data (focused on the proteins

influencing the disorder) of an additional 11,000 volunteers 6,000 with Alzheimer’s compared to 5,000

controls. Funds supporting the new analysis come from fiscal 2014 additions to the NIA budget directed at

intensifying Alzheimer’s research. “We are delighted to support the important research being accomplished

under this broad-based, collaborative effort. This team effort is vital to advancing a deeper understanding of

the genetic variants involved in this complex and devastating disease and to the shared goal of finding

targets for effective interventions,” said NIH Director Francis S. Collins, M.D., Ph.D. The effort is critical

to accomplishing the genetic research goals outlined in the National Plan to Address Alzheimer’s Disease

External Web Site Policy, first announced by the U.S. Department of Health and Human Services in May

2012 and updated annually. Developed under the National Alzheimer’s Project Act (PDF - 125KB) External

Web Site Policy, the plan provides a framework for a coordinated and concentrated effort in research, care

and services for Alzheimer’s and related dementias. Its primary research goal is to prevent and effectively

treat Alzheimer’s disease by 2025.

SAGE LABS INTRODUCES CRISPR/CAS9 REAGENTS TO HELP RESEARCHERS QUICKLY

AND PRECISELY EDIT DNA


Labs Inc., a leading provider of in vivo products, services and technologies in the field of genome

engineering, launchenable researchers to quickly and easily perform genetic engineering in animal models,

such as mice and its SAGEspeed CRISPR/Cas9 reagents. These reagents ed rats, as well as cell lines. Since

2009, SAGE Labs has been using targeted nucleases, including CRISPR/Cas9 and zinc finger nucleases, to

perform genetic engineering in mice, rats, and rabbits as part of their SAGEspeed custom model generation

service. With the launch of SAGEspeed CRISPR/Cas9 reagents, SAGE is now making available these same

custom-designed and validated reagents to the research community. SAGEspeed CRISPR/Cas9 reagents are

available in two different formats. Microinjection-ready reagents come ready-to-inject, prepared in

microinjection buffer and at SAGE’s own optimised concentrations for animal model generation. Reagents

designed for use in cell lines are also available. David Smoller, PhD., chief executive officer, of SAGE

Labs, explained “CRISPR/Cas9 is an exciting new tool for fast and precise gene editing. While assembly of

the CRISPR reagents is relatively simple, design and construction of reagents that perform well can be

challenging. Our scientists have amassed a wealth of experience designing and validating nuclease-based

gene editing tools for over five years, and we’re tremendously excited to be able to share our expertise with

the scientific community by providing the same quality reagents that we use." SAGEspeed CRISPR/Cas9

reagents are provided at three different levels of validation. SAGEspeed Validated reagents include project-

specific design and validation of nuclease activity. SAGE will construct up to five designs and will provide

the best performer. Validated+ reagents also include tools to assess potential off target effects.

STUDY FINDS LOW DOSES OF ARSENIC CAUSE CANCER IN MALE MICE


Researchers at the National Institutes of Health (NIH) have found that mice exposed to low doses of arsenic

in drinking water, similar to what some people might consume, developed lung cancer. Arsenic levels in

public drinking water cannot exceed 10 parts per billion (ppb), which is the standard set by the US

Environmental Protection Agency. However, there are no established standards for private wells, from

which millions of people get their drinking water. In this study, the concentrations given to the mice in their

drinking water were 50 parts per billion (ppb), 500 ppb, and 5,000 ppb. 50 ppb is the lowest concentration

that has been tested in an animal study, and researchers say that because of differing rates of metabolism,

mice need to be exposed to greater concentrations of arsenic in drinking water than humans to achieve the

same biological dose and similar health effects. The researchers used a model that duplicates how humans

are exposed to arsenic throughout their entire lifetime. In the study, the mice were given arsenic three weeks

before breeding and throughout pregnancy and lactation. Arsenic was then given to the offspring after

weaning, and all through adulthood at concentrations relevant to human exposure. The researchers looked at

the tumors in the adult offspring. “This is the first study to show tumor development in animals exposed to

very low levels of arsenic, levels similar to which humans might be exposed,” said Michael Waalkes, Ph.D.,

lead author on the paper and director of the National Toxicology Program (NTP) Laboratory. “The results

are unexpected and certainly give cause for concern.”

ASPIRIN AND SMOKING AFFECT CANCER


New study shows that while regular use of aspirin reduces ageing of cancer genes, smoking can accelerate

them. Scientists had discovered in the 1990s that regular use of aspirin over long periods of time decreases

the risk of developing colorectal cancer by an average of 40 percent, but it is unknown how exactly the drug

influences the cancer risk. According to a research led by Prof. Primo Schar, from the University of Basel

and PD Dr. Kaspar Truninger, aspirin decreased the risk of cancer by slowing down certain aging processes

of the genome, namely modifications that also play an important role in the development of tumors. In

order to analyze the relationships between lifestyle and genome aging, the researchers examined intestinal

tissue samples of 546 healthy women over 50 years of age. They compared age-specific changes of gene

markers, so-called DNA methylations, with their lifestyle factors regarding aspirin use, smoking, body mass

index and hormonal replacement therapy. The most significant effects were measured for aspirin use and

smoking. Schar said that each cell's genome was like a library full of bookmarks, and the cells know which

genes to read with help of these bookmarks, so that they can fulfill their specialized tasks as skin, muscle or

intestinal cells. But these markers were not very stable and change during the course of age, which lead to

development of tumors, he added. First author of the study Dr. Faiza Noreen, added that the factors

especially affected the genes that also play a role in the development of cancer, and Truninger emphasized

that it would be premature to start taking aspirin solely for cancer prevention without consulting a doctor

first, since it potential side effects such as gastrointestinal bleeding.

HIGH CHOLESTEROL LINKED TO BREAST CANCER

Times of India, 9 July, 2014 In a significant discovery, scientists have found a link between high blood cholesterol and breast cancer in a

study of more than one million patients over a 14 year time period in Britain. "Our preliminary study

suggests that women with high cholesterol in their blood may be at a greater risk of getting breast cancer,"

said Rahul Potluri, founder of the Algorithm for Comorbidities, Associations, Length of stay and Mortality

(ACALM) study. It raises the possibility of preventing breast cancer with statins, which lowers cholesterol,

he added. The researchers conducted a retrospective analysis of more than one million patients across

Britain between 2000 and 2013. There were 664,159 women and of these, 22,938 had hyperlipidaemia and

9,312 had breast cancer. Some 530 women with hyperlipidaemia developed breast cancer. The researchers

found that having hyperlipidaemia increased the risk of breast cancer by 1.64 times. "We found that women

with high cholesterol had a significantly greater chance of developing breast cancer. This was an

observational study so we can't conclude that high cholesterol causes breast cancer but the strength of this

association warrants further investigation," Potluri said. The research was presented Friday at "Frontiers in

CardioVascular Biology (FCVB) 2014" seminar in Barcelona, Spain.

VITAMIN D UPS THE SURVIVAL ODDS IN BOWEL CANCER


Bowel cancer patients with high levels of vitamin D in their blood are more likely to survive the disease,

says a study. Patients with the highest levels of vitamin D have half the risk of dying compared to those

with the lowest levels, the findings showed. Often referred to as "sunshine vitamin", vitamin D is made in

the body when the skin is exposed to sunlight. The very few foods in nature that contain vitamin D include

the flesh of fatty fish (such as salmon, tuna and mackerel) and fish liver oils. "Measuring vitamin D levels

in bowel cancer patients could also provide a useful indication of prognosis," the scientists noted. For the

study, researchers at the University of Edinburgh in Britain tested blood samples from almost 1,600 patients

after surgery for bowel cancer. The greatest benefit of vitamin D was seen in patients with stage 2 disease,

at which the tumour may be quite large but the cancer has not yet spread. Three quarters of the patients with

the highest vitamin D levels were still alive at the end of five years, compared with less than two thirds of

those with the lowest levels, the findings showed. "Our findings are promising but it is important to note

that this is an observational study. We need carefully designed randomised clinical trials before we can

confirm whether taking vitamin D supplements offers any survival benefit for bowel cancer patients,"

professor Malcolm Dunlop from the University of Edinburgh added.

CINNAMON CUTS DOWN PROGRESSION OF PARKINSON'S


The popular spice cinnamon can slow down the progression of Parkinson's disease, a study shows. The

discovery can herald a remarkable advance in the treatment of this devastating neurodegenerative disease.

"Cinnamon has been used widely as a spice throughout the world for centuries. The spice can reverse the

biomechanical, cellular and anatomical changes that occur in the brains of mice with Parkinson's disease,"

said Kalipada Pahan, a Floyd A Davis professor of neurology at Illinois-based Rush University. The study

found that after oral feeding, ground cinnamon is metabolised in the liver into sodium benzoate. It then

enters into the brain, stops the loss of important proteins Parkin and DJ-1, protects neurons, normalises

neurotransmitter levels and improves motor functions in mice with PD. Understanding how the disease

works is important to developing effective drugs that protect the brain and stop the progression of PD.

"Now we need to translate this finding to the clinic and test ground cinnamon in patients with PD," Pahan

added. Cinnamon is also widely used as a food preservative due to its microbiocidal effect.

NEW AND GENERIC DRUG APPROVALS

US FDA site

Drug Name Strength Dosage Form /

Route

Marketing

Status

Company

Indium In-111

Oxyquinoline

1mci/Ml Injectable;Injecti

on

Prescription Ge Healthcare

Effexor Xr Eq 37.5mg

Base;

Eq 75mg Base;

Eq 150mg

Base

Capsule,

Extended

Release;Oral

Prescription Wyeth Pharms Inc

Effexor Xr Eq 100mg

Base

Capsule,

Extended

Release;Oral

Discontinued Wyeth Pharms Inc

Telmisartan 20mg; 40mg;

80mg

Tablet;Oral Prescription Glenmark Generics


80mg

Tablet;Oral Prescription Alembic Pharms Ltd

Telmisartan 20mg; 40mg; Tablet;Oral Prescription Mylan Pharms Inc

80mg

Marqibo Kit 5mg/5ml

(1mg/Ml)

Injectable,

Liposomal;Intrav

enous

Prescription Talon Therap


80mg

Tablet;Oral Prescription Torrent Pharms Ltd

Desvenlafaxine 50mg; 100mg Tablet, Extended

Release;Oral

Prescription Alembic Pharms Ltd

Conray 60.00% Injectable;Injecti

on

Prescription Mallinckrodt

Conray 43 43.00% Injectable;Injecti

on

Prescription Mallinckrodt

Celexa Eq 10mg Base;

Eq 20mg Base;

Eq 40mg Base

Tablet;Oral Prescription Forest Labs

Celexa Eq 60mg Base Tablet;Oral Discontinued Forest Labs

Crestor 5mg; 10mg;

20mg; 40mg

Tablet;Oral Prescription Ipr

Vantas 50mg Implant;Subcutan

eous

Prescription Endo Pharm

Quetiapine

Fumarate

50mg; 150mg;

200mg;

300mg; 400mg

Tablet, Extended

Release;Oral

None

(Tentative

Approval)

Mylan Pharms Inc

Valchlor 0.02% Gel;Topical Prescription Actelion Pharms Ltd

Frovatriptan

Succinate

2.5mg Tablet;Oral None

(Tentative

Approval)

Mylan Pharms Inc

Fortical 200 Iu/Spray Spray,

Metered;Nasal

Prescription Upsher Smith

Aplenzin 174mg;

348mg; 522mg

Tablet, Extended

Release;Oral

Prescription Valeant Bermuda

Cayston 75mg/Vial For

Solution;Inhalati

on

Prescription Gilead

***

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