avendus pharma world june 2010

8/8/2019 Avendus Pharma World June 2010

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Dear Reader,

The month of May saw a landmark deal getting inked in the Indian pharmaceutical industry. Piramal

Healthcare sold its domestic formulations business to Abbott for a total consideration of $ 3.72 bn ($

2.12 bn upfront and $ 400 mn per annum for four years thereafter). The deal includes the branded

formulations business (FY10 Revevenue ~ INR 18.2 bn) in India, Nepal & Sri Lanka, the plant at Baddi,

350 brands/trademarks, and ~5250 employees (~4000 sales force). Post the deal, Piramal would

retain its CRAMS, Global Critical Care, OTX, Pathlabs, and other smaller businesses with revenues ~

INR 18.5 bn (FY10). The deal makes Abbott the leader in Indian domestic formulations with a 7%

market share. The apparently rich valuation (9X Rev FY10 & 36X EBITDA FY10) has been clearly driven

by the long term growth story of India (13% nominal GDP growth p.a, and 5% real GDP growth p.a till

2050 as per the Goldman Sachs BRICs report) and the growth potential of the Piramal Abbott

combined entity in that context. Abbott might have also decided to pay a premium as a tax top up

(given that the deal was structured as an asset sale for Piramal) since it is not possible to find a privately held domestic formulations asset of a comparable size in India.

Post the deal, the market is now looking for clarity on the use of the proceeds. The management has

indicated that portions of the cash will be used to repay debt, pay non compete fees to promoters,

and pay out a special dividend to all shareholders, and the remaining cash will be invested in growth

business within and outside pharma. The magnitude of these amounts shall be shall be decided by the

Board post the closure of the sale. Nonpharma investments will certainly change the profile of the

stock (Piramal Healthcare) in the minds of investors. However, to the promoters credit, he has had an

excellent track record of entering a new business (e.g., he entered the pharma business through an

acquisition in 1988 when Piramal was a textile major) and creating shareholder value. That

notwithstanding, it is important for investors to have clarity on the end use of the cash.

The other M&A deals in the domestic space were Ciplas acquisition of two USFDA approved mfg.

facilities ; one in Pune for INR 30 Cr & the other in Sikkim for INR 52 Cr. These were captive sources of

formulations and bulk drugs/intermediates for Cipla.

On the global front, Astellas Pharma bought out US based OSI Pharma for ~$ 4 bn, paying a 55%

premium to its share price before the first bid. The primary motive for the deal was to acquire OSIs

cancer pipeline and blockbuster drug Tarceva. In another $ 3.1 bn transaction, Universal Healthcare

(UHS) bought out Psychiatric Solutions (PS), operator of psychiatric facilities in the US. The combined

entity would now own approximately 175 psychiatric facilities and 21 short term acute care hospitals.

The largest global PE deal in the sector was Providence Equitys buyout of Virtual radiologic, a US

based provider of tele radiology services. The deal was struck at $17.25/share in cash or ~$ 294 mn in

total, which represents a 38% premium to the price before announcement. In another deal, AAC

Capital Partners, the Dutch PE firm, acquired Martindale Pharmaceuticals Limited, a UK based pharma manufacturing & marketing company, from Cardinal Health Inc, for ~ USD 146 Mn.

In this edition of the newsletter, we present an article on the Biosimilars Industry. The recently

passed US legislation goes a step ahead in clarifying a regulatory pathway for the approval of

biosimilars in the US. As the Poker Game in Para IV (refer Avendus PharmaWorld May 2010 edition)

draws to a close, Biosimilars could be the silver bullet that provide the next leg of growth to the larger

generics players and accelerate the demise of the also ran ones.

Avendus Healthcare Team

Avendus Pharmaworld JUNE 2010

CONTENTS

Biosimilars: A silver bullet for the privileged few Pg2

Valuation snapshot Pg9

Newsline Pg10

Contacts:

V.Krishnakumar [email protected]

Yogesh Hede [email protected]

Sushrath Kaul [email protected]

Koushik Bhattacharyya [email protected]

Kaustubh Chandrabhan [email protected]

Disclaimer: The news articles contained herein are only a part of the original articles from the source mentioned and therefore are not complete. In case you need complete articles, please contact us on the email addresses provided above. The news contained herein has been taken from published sources as indicated under each item. Avendus will not be held liable for any erroneous data as published in the source indicated. Avendus also does not take any responsibility for any errors or omissions or results of any actions based upon this information .


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Biosimilars: A silver bullet for the privileged few?

A Follow on biologic (FOB) or Biosimilar, as it is commonly known, has been the one of the most widely discussed topics in the world of pharma in the last few years. The recently passed US Healthcare Bill is expected to pave a regulatory pathway for the approval of biosimilars, thus opening up largest biologics market in the world to generic competition. The impending patent expiry of biologic drugs worth USD 79 billion during 2010 2015 presents a lucrative opportunity for companies with the requisite expertise. Hence large pharma companies have been gearing up to capture a slice of this opportunity by building up capability through acquisitions (TevaBarr, Eli LillyImclone, Hospira Mayne) and partnerships (TevaLonza, Mylan Biocon).

However the Biosimilar game will be a lot more complicated than its small molecule equivalent. Firstly, there will be limited information on the starting block; it is unlikely for biosimilar manufacturers to have the process information and knowledge of the master cell lines used for the innovator product. Without information on the starting block, the concept of establishing bio equivalence does not hold good. Hence the FDA would require clinical trials of varying sizes and types to establish the required extent of sameness with the cost of such trials being $10 40 mn for smaller trials going up to $ 50150 mn for larger trials. It is also expected that FOBs will not lend themselves to substitution by pharmacists and will need to get promoted to doctors. These factors will ensure that competition in biosimilars is limited to players with deep pockets, advanced manufacturing capabilities and strong regulatory expertise. Higher costs and risks also

imply that the generic products will get sold at lower discounts compared to the small molecule equivalents. Current outlook suggests a 2030% in selling price for biosimilars vs. the 9095% discounts seen in small molecule generics.

Notwithstanding the above challenges, many Indian companies have been preparing themselves for the opportunity. Most major players have committed significant capex to set up development and manufacturing capabilities. Large players like Dr Reddys, Biocon, Lupin and Cipla have a suite of biosimilar products that are marketed in India and other emerging markets. Other companies like Reliance Lifesciences, Intas Biopharmaceuticals, Bharat Biotech and Serum Institute have also initiated Biosimilar projects. However, the high risk and large investments involved in addressing the regulated markets have necessitated collaborations with MNC players in most cases.

The world

of

biologics

Biologics or biopharmaceutical drugs are medicinal products that have biological sources (usually live organisms or their active components like proteins and gene sequences). Biologics exhibit high molecular complexity; the molecules of a biological drug are much larger, have far more complex spatial structures and are a lot more diverse (heterogeneous) than those of small molecule drugs (chemical drugs). On a broad basis, the term biologics include the following categories:

Monoclonal antibodies eg : Humira, Remicade Recombinant proteins eg : Epogen, Enbrel Vaccines eg: Prevnar, Gardasil

The Biologics market has outperformed the overall pharma market by significantly. Between 2006 & 2009, the Biologics market grew by ~13% thereby increasing its share in the Global Pharma market from 9.8% in 2006 to 11.4% in 2009. Two

factors have been crucial to the commercial success of Biologics (1) They address clinical needs that have proven unmanageable with conventional therapeutics (including many cancers and genetic diseases) and (2) Premium pricing due to the lack of alternative medication.


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In the last decade, a number of biopharmaceuticals have grown to become blockbusters (Sales >USD 1 Billon). Over25% of the top 50 drugs by sales in 2009 were biologics. The top 10 selling biologics, which recorded over $ 40 billion in sales in the year 2009, have been listed below.

S No Product Drug Indication Company 2009 Sales ($ Bn)

1 Bevacizumab Avastin Colorectal Cancer Roche 5.8

2 Rituximab Rituxan NonHodgkin's Lymphoma Roche 5.6

3 Adalimumab Humira Rhematoid Arthritis Abbott 5.5

4 Transtuzumab Herceptin Breast Cancer Roche 4.9

5 Infliximab Remicade Rhematoid Arthritis J&J 4.3

6 Insulin Glargine Lantus Diabetes Sanofi Aventis 4.3

7 Etanercept Enbrel Rhematoid Arthritis Amgen 3.5

8 Pegfilgrastim Neulasta Neutrpenia Amgen 3.4

9 Darbepoetin Alfa Aranesp Anemia Amgen 2.7

10 Epoetin Alfa Epogen Renal Anemia Amgen 2.6

Source : Bloomberg (figures represent company sales)

The Biosimilars Opportunity

The Biosimilars opportunity is significant because USD 80 billion worth of biologic drugs are set to lose patent protection between 2010 and 2015. This, along with increasing focus on healthcare cost containment is expected to provide an impetus to the growth of the biosimilar market.

Source: Business Insights; Bloomberg *Represents company sales

Generic Name Reference Product Revenues *2009 ($ mn) Patent Expiry in US

Transtuzumab Herceptin 4864 2012

Infliximab Remicade 4304 2014

Etanercept Enbrel 3493 2012 Pegfilgrastim Neulasta 3353 2015

Darbapoeitin Aranesp 2652 2014

Epoietin Alfa Epogen 2569 2013

Interferon beta 1a Avonex 2322 2013 (2012 in EU)

Epoietin Alfa Procrit 2200 2013

Interferon beta 1a Rebif 2142 2013

Filgrastim Neupogen 1288 2013 (2007 in EU)

Share of Biologics in the Global Pharma market

Source: Pipelinereview.com; IMS

63.878.9 82.3

91.8

010

2030405060708090

100

2006 2007 2008 2009

Global Biologics Market (USD Bn)

90.16% 89.00% 89.47% 88.64%

9.84% 11.00% 10.53% 11.36%

0%

20%

40%

60%

80%

100%

2006 2007 2008 2009

Non Biologics Biologics


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Break up of Biosimilars by market (2007) Biosimilars Pipeline by countries (2007)

Source: Datamonitor

Currently, the major biosimilar players are focused on emerging markets and EU, but are expecting to secure a greater portion of their business from the US going forward. Also, the biosimilars currently marketed represent a narrow set of six

therapeutic classes.

Launches

are

expected

to

get

more

broad

based

in

the

future

given

the

pipeline

of

patent

expiries.

Marketed Biosimilars by class (2007) Pipeline Biosimilars by class (2007)

Source: Datamonitor

Major Biosimilar Players

Currently, the global biosimilars market is fragmented with the top 10 payers accounting for less than 15% of the total biosimilar sales. The experience of marketing biosmilars in stringently regulated western market is limited as only 13 biosimilar drugs have been approved in the EU till now. Large generic players like Sandoz, Teva, Hospira, Stada, Bioton

(parent of

Biopartners),

having

experienced

initial

success

in

the

EU

biosimilars

market,

are

well

placed

to

capitalize

on

the

US market opportunity. Big Pharma companies that are bullish on biosimilars (Merck, Eli Lilly) are also wellplaced because of the regulatory & marketing expertise that they have gathered over the years through their branded business.

Considering the investments required and the process complexity in biosimilars, we expect the larger players mentioned above to lead the race when it begins. The smaller players (especially the Generics champions of India & China) might not be able to access the US/ EU markets on their own, as they have done in the case of smallmolecules..

Eastern Europe, 3%

APacific (ex Jap), 2%

Others, 5%

Canada/US, 48%

Major EU Countries, 42%

Eastern Europe, 27%

APacific (ex Jap), 27%

Others, 20%

Canada/US, 13%

Major EU Countries,

13%

GCSF, 21%

EPO, 17%

HGH, 12%Interferon Beta, 10%

Interferon Alfa, 8%

Coagulation factors, 7%

Interferon Gamma, 5%

PTH, 5%

GMCSF, 3%

Insulin, 3%Others, 9%

HGH, 33%

Erythropoietin, 17%

GCSF, 17%

Interferon Alfa, 17%

GMCSF, 8%

Insulin, 8%


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Europe The early mover

Europe has established a significant lead over the US in the introduction of biosimilars. In February 2006, after several iterations, the EMEA and its Committee for Medicinal Products for Human Use (CHMP) released a set of guidelines providing an assessment of the quality, safety and efficacy requirements for biosimilar products. The same year in April, two biosimilars (Sandoz Omnitrope & Biopartners Valtropin) of Somatropin were approved in the EU. The EMEA/CHMP

continues to review and develop their guidelines, with several meetings scheduled for 2010. Broadly, the EU framework offers a 10year period for innovator exclusivity, with the opportunity for an additional year for new indications.

The EMEA guidance states that an extensive comparability exercise will be required to demonstrate that the similar biological medicinal product has a similar profile in terms of quality, safety and efficacy to the reference medicinal product . The EMEA guidelines for novel production processes for biosimilars suggest that potential applicants should demonstrate consistency and robustness of the manufacturing process. Moreover, these guidelines indicate that, in addition to in vitro testing and pharmacokinetic studies, clinical trials are likely to be required to compare the potential biosimilar to the reference product. Other published papers suggest that non clinical studies are unsuitable for showing similarity and clinical studies comparing the biosimilar to the original biotherapeutic are necessary. However, the published EMEA guidelines also state that clinical studies are not required if in vitro characterisation of the protein can

demonstrate similarity to the original reference drug, but this seems unlikely, at least in the near future. To date, 13 biosimilars have been approved in Europe (excluding insulins) and all have gone through clinical trials. The cost of running one clinical trial vs the reference drug is $50 150 million, depending on the specific drug and targeted indication.

Given below is the list of Biosmilars authorized by EMEA for launch in the EU market:

S No Biologic Biosimilar brand Company

1 Somatropin Omnitrope Sandoz

2 Somatropin Valtropin Biopartners

3 Epoetin Alfa Binocrit Sandoz

4 Epoetin Alfa Epoetin Alfa Hexal Hexal

5 Epoetin Alfa Abseamed Medice

6 Epoetin Zeta Silapo Stada

7 Epoetin Zeta Retacrit Hospira

8 Filgrastim Filgrastim Ratiopharm Ratiopharm

9 Filgrastim Ratiograstim Ratiopharm

10 Filgrastim Biograstim CT Arzneimittel

11 Filgrastim Tevagrastim Teva

12 Filgrastim Filgrastim Hexal Hexal

13 Filgrastim Zarzio Sandoz Source: EMEA Website

US Some clarity emerges

After a long wait, the US has finally come up with some clarity on the regulatory pathway for biosimilars. On March 21 st , the House of Representatives voted by a narrow 219 212 margin to agree to the version of the Healthcare reform bill that the Senate passed on December 24, 2009 . On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act of 2010 ("PPACA") . The Biologics Price Competition and Innovation Act of 2009 (Biologics Act) is included as a subtitle of the Healthcare Bill, and it creates a framework for FDA approval of followon biologics.

Some of the key provisions in the Biologics Act have been listed below:


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1. Approvability & Interchangeability : For a followon biologic to be deemed biosimilar , data must be produced to show that the biological product is (a) highly similar to the reference product notwithstanding minor differences in clinically active components ; and (b) exhibits no clinically meaningful differences relative to the reference product in terms of safety, purity, and potency. A biosimilar drug is considered to have a new active ingredient compared to the reference product.

For a follow on biologic to be deemed interchangeable , data must be produced to show that the biological product (a) is biosimilar to the reference product; and (b) can be expected to produce the same clinical result in any given patient as the reference product. Furthermore, if the biological product is administered more than once to an individual, it will only be deemed interchangeable if the risk (in terms of safety or diminished efficacy) of switching between the biological product and the reference product is not greater than the risk of using the reference product without such switch. A biological product that is interchangeable will be considered to have the same active

ingredient as the reference product .

2. Exclusivity for the innovator : The Act includes provisions for innovator product data and market exclusivity. The FOB applicant may not submit an application for approval for 4 years after the reference product was first approved. There are provisions for data exclusivity to the innovator and the FDA may not approve an FOB application until 12 years after the reference product is first licensed.

The bill, to a certain extent, also has an anti evergreening provision as it mentions that no new exclusivity is granted

for BLA

supplements

or

subsequent

applications

for

a

new

indication,

route

of

administration,

dosage

form,

or

strength

of a previously licensed biologic.

3. Exclusivity for First Interchangeable Biological Product: If a followon biologic is approved by the FDA and is deemed to be interchangeable (not merely biosimilar), then the applicant receives the lesser of one year of exclusivity after the date of first commercial marketing or eighteen months of exclusivity after FDA approval (or 42 months exclusivity after initial approval of the followon biologic if patent infringement is ongoing).

4. Patent infringement litigation: The Act does not adopt Hatch Waxman's "Orange Book" listing for purposes of patent infringement litigation. Instead, a process is established that allows the followon biologic applicant and the reference product sponsor (innovator) to exchange information regarding those patents against which the reference product sponsor (or exclusive license holder) could potentially assert a claim of patent infringement and those patents that the

reference holder

has

agreed

to

license

to

the

applicant.

Following

"good

faith

negotiations"

on

an

agreed

upon

list

of

patents and associated claims, the Act creates an expedited litigation procedure. The reference product sponsor must bring suit within 30 days of either the date an agreement is reached on the list of disputed patents or 30 days from the date in which it was formally determined that an agreement could not be reached. Failure to bring a lawsuit in this time frame means the reference product holder risks forfeiting future recovery and royalties. In addition, the followon biologic applicant must provide notice to the reference product sponsor 180 days before launching an approved followon biologic in order to give the reference product sponsor an opportunity to file for preliminary injunction relating to patents that were initially identified by the reference product sponsor as being potential infringements but were not included on the exchanged list of patents subject to the expedited litigation procedure.


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What it means for Indian Companies

Indian companies, having done very well in small molecule generics, have been gearing up for the biosimilars opportunity. Most of the leading Indian companies have products in India and semi regulated markets, and many plan to launch additional products, in some cases in developed markets, either on their own or through collaborations. DRL has been on the forefront of Biosimilars development in India. Having launched Reditux (rituximab) in India & Grafeel (GCSF) in India, Latam, SE Asia & CIS, it looks forward to replicate this success for its 2 biosimilar molecules in clinics and another 8 molecules in preclinics. The company intends to partner with Big Pharma companies for a launch in EU /US for as and when the products are ready. Lupin is another player which is betting big on the biosimilars story. It plans to pump in ~INR 250 Cr in establishing a research unit for biosimilars, Lupin Biosimilars Research organization, and its own manufacturing

unit in Pune. With these initiatives, the company expects to be ready with the manufacturing technology, processes and products by the time the US market starts seeing biosimilar approvals, 34 years down the line. Cipla, Biocon and Intas Biopharma have gone ahead and forged partnerships for the development & marketing of biosimilars. We believe that as the developed markets open up, the efforts & investments of Indian companies would help them capitalize on the opportunity.

The positions being taken by major Indian players in biosimilars are summarized below:


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Source: Analyst Reports, Avendus Research

Conclusion While the US biosimilars market will certainly open up, it is not clear how Indian companies will be able to access that market on their own. There are 4 key requirements in the Biosimilars model (i) Large amounts of capital, (ii) High process complexity, (iii) Risk of clinical trials, and (iv) ongoing requirement of doctor promotion that will ensure that the commercialization of biosimilar products remains the prerogative of global generics and innovator companies. Even if Indian companies were to bear the risk and cough up the monies required to develop these products, they will not be able to access the US/ EU markets by pumping lowcost alternatives through pharmacist channels. Indian companies seeking to build a stand alone commercial presence in this business will need to acquire local specialty businesses that cover doctors from the 3 critical specialties: Oncology, Hematology and Orthopedic. The products developed in India (or locally) can then be detailed and marketed through the specialty channels. However the larger specialty companies in the world are too large for Indian companies to acquire; hence the latter need to start looking for hidden gems of the right sizes and profiles. Till they do that, Indian firms will need to focus on innovation and product development, and remain content with having to partner with bigger companies for commercialisation. In that sense, we see Biosimilars as a silver bullet for the privileged few; the privileged few being global pharma companies with deep pockets and abilities to commercialise drugs on a global scale.

Company Products marketed Products in the pipeline Other initiatives

Bharat Biotech streptokinase, EGF, vaccines Vaccines

Biocon insulin,erythropoetin, nimotuzimab, streptokinase, filgrastim

hGH, interferon, MABs Partnership with Amylin for peptide drugs, partnership with Mylan

Cadila insulin, filgrastim, streptokinase

Cipla na anti TNF 50:50 JV with Chinese company to be

called Biomab

Claris filgrastim, erythropoetin na

DRL filgrastim, rituximab 8 in pre clinics, 2 in clinics

Looking for partners for US & EU

Emcure erythropoetin, filgrastim nd Has inhouse PEGylation technologies

Intas Biopharma erythropoetin, filgrastim, pegfilgrastim, folistim, interferon alpha

MABs, cytokines Deal with Apotex for codevelopment & supply of filgrastim in North American market

Lupin EGFR, abciximab pegfilgrastim, interferon MABs, insulin

Investment in FOB facility

Ranbaxy erythropoetin, filgrastim filgrastim (for EU) Inlicensed product from Zenotech

Reliance Life interferon alpha, erythropoetin, filgrastim

MABs TPA (tissue plasminogen activator)to be launched in India.Epo & GCSF in Ph III

for launch in EU Shantha Biotech erythropoetin, interferon alpha,

streptokinase PEGinterferon, tPA

Shreya insulin, erythropoetin,follitropin, hGH

nd

Wockhardt insulin, erythropoetin, insulin glargine

interferon alpha, filgrastim, insulin glargine, insulin lispro

Significant investment in manufacturing facility

Zenotech filgrastim, sangramostim, interleukin 2

MABs Deal with Ranbaxy for filgrastim in regulated markets, Ranbaxy owns a large stake


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Valuation Snapshot(As on 31 st May 10)

Company Market Cap

(INR Cr) Enterprise Value

(INR Cr)

1 yr Stock

Return EV/ Revenue EV/ EBITDA P/E

CRAMS Piramal Healthcare 10756 12001 99% 3.3 16.2 22.3 Divi's Lab 9843 9881 29% 10.3 23.1 28.9 Dishman 1647 2325 7% 2.5 10.1 14.0 Jubilant Organosys 5460 8957 74% 2.4 11.1 12.9 Suven Lifesciences 322 363 14% 2.8 27.8 45.9

CRAMS Mean 4.5 18.0 25.4

CRAMS Median 2.8 16.2 22.3

Generics Sun 34,401 32,910 37% 8.0 24.1 25.5 Cipla 25,609 26,495 43% 4.7 19.5 23.7

Glenmark 7,321 9,344 19% 3.7 14.4 22.1 Lupin 16,559 17,705 123% 3.6 18.0 23.7

Generics Mean 5.0 19.0 23.7

Generics Median 4.2 18.7 23.7

India Branded Formulations Pfizer 3,154 2,610 40% 3.3 11.7 21.4 Glaxo 17,837 16,109 81% 8.2 21.8 33.0 Indoco 500 527 136% 1.3 9.1 11.9 FDC 1,789 1,767 145% 2.7 9.0 12.0 Wyeth 1,762 1,559 44% 4.0 11.7 19.7 Novartis 1,910 1,857 34% 3.0 10.2 16.5 IBF Mean 3.8 12.2 19.1 IBF Median 3.1 10.9 18.1

Hospitals Apollo Hospitals 4,590 5,173 45% 2.8 16.5 30.2 Fortis 4,554 4,975 41% 5.0 25.9 63.6 Kovai Medical 179 228 61% 1.7 8.5 15.5 Indraprastha medical 416 462 21% 1.1 6.6 13.4 Hospitals Mean 2.6 14.4 30.7 Hospitals Median 2.3 12.5 22.9

Mean 3.9 15.5 24.0 Median 3.3 14.4 22.1


10/23

News: Partnerships and Alliances

Glenmark in licensing pact with Sanofi Aventis:

Economic Times

Glenmark Pharmaceuticals Ltd signed a licensing agreement with France's Sanofi Aventis for development and

commercialisation of

novel

agents

to

treat

chronic

pain.

Under

the

terms

of

the

agreement,

Glenmark

will

receive

an

upfront payment of $20 million, and licensing fees could come to $325 million, it said in a statement. "In addition to

licensing fees, we expect to receive double digit royalties on sales of products commercialised under the license,"

Glenmark Chief Executive Glen Saldhana told CNBCTV18 television channel.

The novel agents to be developed under this deal include vanilloid receptor (TRPV3) antagonist molecules, the company

said in statement. The GRC15300, one of the molecules being developed, is currently in phase I of clinical development, it

added. "It's a very positive deal. The project is in the first phase. If implemented, it would generate the expected revenue

in next five to six years," a pharma analyst told Reuters over the telephone.

Under the agreement, Sanofi Aventis will have exclusive marketing rights for these novel agents in North America,

European Union and Japan subject to Glenmark's right to copromote the products in the U.S. and five East European

countries. Sanofi Aventis will also have comarketing rights in 10 other countries including Brazil, Russia and China.Glenmark will retain exclusive rights in India and other countries of the rest of the world.

Glenmark in licensing deal with Par Pharma for cholesterol drug:

Economic Times

Glenmark signed an exclusive licensing agreement with the USbased Par Pharmaceutical to sell generic cholesterol

lowering drug Ezetimibe in the US market.

Ezetimibe is a generic version of Merck Schering Plough's patented drug Zetia and Glenmark is currently fighting a patent

litigation in the US over the drug. Glenmark claims that it has first to file status on Ezetimibe tablets, thereby providing a

potential of 180 days of marketing exclusivity in the US market.

"Under the agreement, Glenmark has received a payment from Par for acquiring exclusive rights to market, sell and

distribute the product in the US," Glenmark said in a statement. The company, however, did not disclose the sum citing

confidentiality clause.

"The companies will share the profits from the sales of the product," Glenmark said, adding Zetia has annual sales of

around USD 1.4 billion in the US, quoting IMS Health Data. Moreover, it said Par will also share the cost of the ongoing

litigation in Ezetimibe is a New Jersey district court.

Merck's patent for Zetia expires in 2016, but the company bagged a re issued patent during 2002 03.

Glenmark had got the tentative approval for the drug last year through its USbased subsidiary Glenmark Generics for

Ezetimibe tablets in 10mg strength. Glenmark had filed an abbreviated new drug application (ANDA) with the US food and

drug administration seeking regulatory approval on October 25, 2006.

Orchid Chemicals signs out licensing deal with Alvogen:

Economic Times

Orchid Chemicals and Pharmaceuticals signed an out licensing and distribution agreement with USbased Alvogen for eight

formulations having a market size of $8 billion.


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As per the agreement, the Indian company will develop and manufacture eight oral non antibiotic formulations for

licensing and marketing by Alvogen in the US.

According to Alvogen, regulatory applications have already been submitted for three of the eight products under the

agreement. Two of these have received tentative approvals from the US Food and Drug Administration (USFDA).

A further five products are under development. The products are expected to be launched in the US market beginning

2011.

Outside the US, Alvogen has identified 20 emerging markets in Europe, Asia and Latin America as its priorities for entry and expects to be operational in 15 countries by the year end. Alvogen will source the drugs only from Orchid Chemicals. It

would pay certain dossier licence fees to Orchid based on development and regulatory milestones and share profits arising

from marketing of these products. Both the companies would share the legal expenses and biostudy costs.

"Orchid has created a strong base in the US generics market through its antibiotic and non antibiotic product portfolio.

Moving forward, we are progressing on further leveraging on our non antibiotic product portfolio," said Managing Director

K. Raghavendra Rao.

Glenmark enters into licence, supply pact with Taro Pharma:

Economic Times

Glenmark Pharmaceuticals entered into a licencing agreement with USbased Taro Pharmaceuticals Inc to supply branded

products in the US markets.

The USbased subsidiary of the company, Glenmark Generics Inc, has entered into a licence and supply agreement for a

branded product with a unit of Taro Pharmaceutical Industries. Under the agreement, Glenmark would manufacture the

US Food and Drug Administration approved product exclusively for Taro USA, the filing added. Glenmark would receive

milestone payments and a royalty on sales. "Additional terms of the agreement are not being disclosed," the company

said. Taro USA's branded division Taro Pharma would be the exclusive United States distributor of the product, it said.

Cipla, Pfizer in talks for supply & production pact:

Economic Times

CIPLA is in talks to make and supply drugs to global pharmaceutical firm Pfizer as the USbased company plans a foray in

the generics business space, a person in the know told ET. If the deal materialises, Cipla is expected to make inhalers,

drugs for respiratory disorders and anti infectives for Pfizer. At present, they are in talks for around 18 products, the

person said. The deal is expected to be divided into two parts. The first would be a licensing fee of around $150 million for

Indias largest drug maker by sales, and then profit share from sale of those products. The Cipla spokesperson declined to

comment.

Abbott signs licensing, supply deal with Zydus Cadila:

Economic Times

Abbott signed a licensing and supply agreement with Zydus Cadila for 24 products to be sold in 15 emerging markets. The

company, however, did not specify financial details of the agreement, which also includes an option for the addition of

more than 40 products from the Indian drug firm. Under the agreement, Abbott will gain rights to at least 24 Zydus

products in 15 key emerging markets where Abbott has a strong and growing presence. The agreement also includes an

option for the addition of more than 40 Zydus products to the collaboration, Abbott said in a statement.

"The Zydus agreement complements our established products strategy, augmenting this business with a broad portfolio of

branded generics," Abbott executive vicepresident, Pharmaceutical Products Group, Olivier Bohuon said.


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The collaboration includes medicines for pain, cancer and cardiovascular, neurological and respiratory diseases.

"The partnership will leverage Abbott's powerful emerging markets infrastructure to commercialize the Zydus products,

with product launches beginning in early 2012," it added.

Commenting on the collaboration Zydus Cadila Chairman and Managing Director Pankaj R Patel said, "We have always

believed in working with partners for winwin alliances that look at new opportunities for growth and expansion.

"In this alliance we see tremendous opportunity to participate in multiple ways in a market that is growing and expanding

rapidly." Abbott also said it has created a standalone established product division with a $5 billion in current pharmaceutical sales

to focus on emerging markets. "Our new Established Products Division, with $5 billion in sales, will focus on expanding our

presence and product offerings in the world's fastest growing emerging markets," Bohuon said.

Strides signs new generic supply deals with Pfizer:

Livemint

Strides Arcolabs Ltd and Pfizer signed two more product partnership deals to cater to the global market. In January, the

two had entered into a similar product licensing deal for another set of generic drugs. Under the new deals, Strides will

license and supply up to 38 generic cancer drugs to Pfizer for markets in the European Union, Canada, Australia, New Zealand, Japan and Korea, and a range of injectables for the US market.

These drugs, supplied by Strides in specific dosages, will be commercialized by Pfizer through the generic drug business it

recently set up called established products business unit.

We are excited about extending our important partnership with Strides to reach an even larger global patient

population, David Simmons, president and general manager of the established products business unit, said in a release.

Under the January agreement between Strides and Pfizer, the Indian company will deliver 40 generic drugs, which also

includes some cancer therapies, for the US market.

The new deal validates our strategic intent to be a partner of choice to Pfizer, said Arun Kumar, vicechairman and group

chief executive officer of Strides.

Pfizer, which had last year initiated its plans to enter global generic drug markets including India, has partnered

Hyderabad based Aurobindo Pharma Ltd and Ahmedabad based Claris Lifesciences Ltd to source cheap generic drugs from

the country.

While these product outlicensing deals (have been) negotiated at a comparatively low margin, it helps (the Indian

companies) in capturing a regular business from new global markets without taking the risk of directly entering those

markets, said a pharma industry analyst.

Biocon, Optimer sign agreement for making fidaxomicin:

Business Standard

Biocon entered into an agreement with the USbased Optimer Pharmaceuticals Inc for manufacturing antibiotic drug

fidaxomicin, which is used in treatment of colon infection.

"Our partnership with Optimer is another wonderful recognition of Biocon's capabilities as an R&D partner as well as an

acknowledgment of our global manufacturing facilities," Biocon Group Chairman and Managing Director Kiran Mazumdar

Shaw said in a statement. Optimer President and CEO Pedro Lichtinger said that the longterm agreement with Biocon is

an important step in establishing a stable supply of fidaxomicin.


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"For the past five years, Biocon has been an important partner in our fidaxomicin development programme and we look

forward to continuing the relationship," Lichtinger said.

The drug is used in treating CDI, which is caused by clostridium difficile a spore forming bacterium that can cause serious

infection of the colon by multiplying and producing toxins resulting in inflammation, severe diarrhea and, in serious cases,

death.

News: Domestic

MNCs back in control of 50% of Indian pharma market:

Economic Times

Foreign drugmakers are poised to regain the supremacy they ceded during the 1970s, thanks to their strategy of gobbling

up Indias leading pharma companies. The buyouts, including the acquisition of Piramal Healthcares generic medicine unit

by US based Abbott Laboratories for $3.7 billion, have seeded many gains for these companies, notably a market share

that has soared to 25% from 15%. Analysts say pharma MNC will continue in the same vein and soon control nearly 50% of

the $9.5 billion domestic retail drug market. In the next 34 years, foreign players market share should cross 40% in the

domestic retail market through the inorganic route. The Piramal buyout helped Abbott emerge from oblivion and become

the countrys top pharma company with a 7% market share. Likewise, Japans Daiichi Sankyo, which barely had a presence

in India in 2008, ranks third in the drug market sweepstakes with a 4.9% share after it bought Ranbaxy Laboratories for

$4.6 billion in June that year. Cipla is the lone Indian name among the top three pharma companies with a 5.4% market

share. UKs GSK is ranked fourth with a 4.3% share.

Today, three of the countrys top five drug firms are foreign MNCs, whereas there were hardly one or two MNCs in the top

10 in 2007. For pharma MNCs, Indian companies provide a diverse strategic value and entry to lucrative emerging markets.

While Daiichi Sankyo gained access to 54 countries and broke into generics through its Ranbaxy buyout, Abbott is due for

bumped up sales from India and other emerging markets. Likewise, Frances Sanofi Aventis gained new products and a

flourishing research pipeline by buying Hyderabad based Shantha Biotech. Rivals Pfizer, GSK and Astrazeneca, meanwhile,

have tied up with several Indian firms to sell branded generics in emerging markets. Global MNCs lorded over more than

75% of the countrys drug market before the Indira Gandhi led government adopted a process patent regime in 1971. It

allowed Indian companies to sell generic drugs by tweaking the original process, enabling them to launch an array of

products. Soon, even fringe players like Mankind Pharma and Alkem became formidable forces. And in the late 1990s and

earlier this decade, a string of Indian firms led by Ranbaxy, Dr Reddys Laboratories and Sun Pharma, representing the bold

new face of Indian pharma snapped up companies globally to strengthen their presence in the US and Europe. Foreign

players were pushed into a corner. Their market share shrunk to 1415 % in 2007. But global MNCs in the face of shrinking

revenues and the prospect of further losses when patents of drugs worth $70 billion expires by 2013 began to amplify

their presence in generics from 2008. Generics happened to be a segment they shun till a few years ago. Through a series

of buyouts by companies such as Daiichi Sankyo (Ranbaxy), Abbot (Piramal Healthacre), Sanofi Aventis (Shantha Biotech)

and Fresenuis Kabi (Dabur Pharma), the tables seem to have turned on Indian drugmakers. As per market research, Indias Rs 42,000 crore drug retail market is growing annually at 17%.

Overseas players have also put in place aggressive organic plans. Post integration, their organic growth coupled with the

launch of patented products is expected to vault their market share to 50% by 2015. Ranbaxy has hired 1,500 people to

beef up its sales force and will launch 100 new products in 12 months. Abbott will use Piramals sales force. At 7,000, it is

the countrys largest to sell existing and new products, including patented ones. MNCs need to rapidly ramp up their

generic business, particularly in emerging markets. Emerging markets like India with an annual growth of more than 15%

are seen as the main drivers of the global $837 billion market, projected to grow between 46% a year. So analysts say it

will not be surprising to see Pfizer getting more aggressive to offset a loss of $13 billion in annual sales from patent expiry


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of its blockbuster drug Lipitor in November 2011. For patients, the consolidation spells the prospect of costlier medicines,

especially patented drugs. India adopted a new patent regime in 2005, giving patent owners rights to 20 years of exclusive

marketing. Obviously, Abbot will not sell their drugs at the same price as Piramal did. This should be a matter of concern

for the government and civil society, Indian Pharmaceutical Alliance secretary general D G Shah said. Currently, only 74

bulk drugs are under the governments direct price control. But responding to industry concerns, the government is

examining a proposal to restrict the current 100% foreign direct investment allowed in the sector. Such acquisitions will

not stop without a law to prevent it. This is a serious matter of concern for civil society, said lawyer Anand Grover, who has

long led patent challenges to lower drug prices. Lawyer activists like Grover point to Indias appalling healthcare system.

More than 90% of patients pay from their own pocket for health costs and for a quarter of the population who live below

poverty line, healthcare is beyond reach, they say. But Cipla joint MD Amar Lulla said such deals are choices of individual

companies. This does not in any way set a pattern, he said. The business has merely changed hands and competition

remains the same, he said. Even so, a few billion dollars will not check global majors from scouring for buyouts to save

falling sales. Indias pharma market, including exports and institutional sales, is valued at Rs 1,00,000 crore or $25 billion.

In contrast, Pfizer paid $67 billion to acquire Wyeth. Likewise, Merck was happy to shell out $41 billion to merge with

Schering Plough.

Malaysias Khazanah Launches USD 841.5 mn offer for Parkway:

Asia Pulse Businesswire

In a direct challenge to India's Fortis Healthcare, the Malaysian government's investment firm Khazanah launched an

US$841.5 million partial offer to increase its stake in Parkway Holdings. Fortis Healthcare had in March this year acquired

23.9 per cent stake in the Singapore based healthcare firm Parkway Holdings for US$685.3 million (nearly Rs 31 billion)

from US firm TPG.

Khazanah's partial offer is being made at S$3.78 per share by its group company Integrated Healthcare Holdings Ltd (IHHL)

and through the offer aims to increase its holding in Parkway to 51.5 per cent interest. A partial offer is made to buy some

of the stocks in a publiclytraded company for a price well above fair market value, with the company making the offer

specifying the maximum number of shares it will buy.

"The offer represents a premium of 25.2 per cent of Parkway's last closing price on May 26, 2010," IHHL said in a

statement. Under the terms of the partial offer, IHHL proposes to acquire 313 million shares in Parkway, it added.

"The partial offer enables Parkway shareholders to realise value for some of their Parkway shares now ... and at the same

time retain an interest in its exciting future," IHHL Director Ahmad Shahizam Mohd Shariff said.

The offer comes over two months after Fortis Healthcare acquired 23.9 per cent stake in Parkway that catapulted the

Indian hospital chain as one of the leading healthcare service providers in Asia with a network to 62 hospitals with

combined bed strength of over 10,000 beds. When contacted, Fortis Healthcare officials declined to comment on the

development.

At the time of acquiring stake in Parkway, Fortis had stated that it intends to seek four seats on the board of directors of

Parkway and also to nominate Malvinder Mohan Singh (current Chairman of Fortis Healthcare) as the Chairman of the board of the Singapore based firm.

"This acquisition will significantly expand our footprint across the region and place us strategically for geographical and

clinical leadership in Asia, a big step closer to our vision of establishing a global healthcare delivery network," Singh had

said.

The IHHL offer pitches it against Fortis' plan to spread presence across Asia."The IHHL group will consolidate Khazanah's

existing stakes in Parkway, Pantai, Apollo and IMU to become Asia's premium regional healthcare platform," Shariff added.


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Biocon bets big on bio clones of key drugs:

Hindustan Times

Pharmaceuticals major Biocon has carved out a strategic shift in its growth plan with biosimilar drugs expected to garner

more than a quarter of its revenues over the next five years. Biosimilar medicines, which include insulin and various

vaccines, are made through biological processes and not by chemical synthesis.

At present, biosimilar drugs account for about 10 per cent of the company's revenues.

Biocon plans to tap the emerging markets of Latin America, North Africa, China, Korea, India and Russia with its range of

biosimilar products.

"The market for biosimilar products is growing at around 30 per cent per annum in the emerging markets, which will

bolster growth," Kiran Mazumdar Shaw, chairman and managing director of Biocon, told Hindustan Times. As the

regulatory framework for biosimilar products becomes clear in developed countries in the US and Europe, the company

would expand its presence in those markets, she said.

The market for biosimilar products in emerging countries is estimated at around Rs 4,600 crore and the same accounts for

around Rs 750 crore in India.

The regulatory path for biosimilar drugs is more challenging than the chemically synthesised generic drugs, since the

pharma company needs to prove clinical efficacy and efficiency in order to manufacture a biosimilar product.

Approvals for the manufacture of biosimilar products are granted only after a firm shows abilities to conduct clinical trials

and that its biosimilar medicine is comparable and not inferior to the innovator product.

"Insulin and antibodies offer the biggest opportunities in biosimilar drugs," Shaw said.

Dishman Pharma to raise Rs 75 crore via NCD:

Published by HT Syndication with permission from Accord Fintech

Dishman Pharmaceuticals and Chemicals will be raising Rs 75 crore via issue of second tranche of Secured Redeemable

NonConvertible Debentures (NCD). The Company is planning to spend Rs 125 crore for its expansion, out of which it would raise Rs 75 crore via debentures and remaining Rs 50 crore via its internal accruals. The company is planning to set

up four new active pharmaceutical ingredient (API) plants which are expected to be operational by March 2011. APIs are

active chemicals used in the manufacture of drugs. The new plants will increase the drug production capacity by 400 cubic

metres. The expansion work has already begun at the present site in Bavla (Gujarat state).The company received approval

for raising Rs 75 crore via debentures in a meeting of board of directors which was held on May 29, 2010.

US based Allergan to introduce more products, expand Indian biz:


USbased pharmaceutical firm Allerganis looking at expanding its product range in India as part of a strategy to enhance its healthcare and aesthetic skincare business in the country.

"Aesthetic skincare is a big focus area of the company. India is an untapped market and we see a huge potential. We plan

to introduce a lot of other products for breast implants and obesity soon from our global portfolio," Allergan India

managing director R Raghu Kumar said.

The company, which mainly sells eye care products under brands like 'Optive', 'Relestat' and 'Refresh Tears', said its

skincare business currently accounts for 30 per cent of the overall sales in the country. Allergan's annual sales revenue in

India is Rs 100 crore (US$21.4 million), according to information available on the company website.


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Under the aesthetic skincare business, which involves various skin treatments using advanced technology, Allergan has

brands like 'Botox' (Botulininum Toxin Type A), a product used for removing wrinkles and other skinrelated problems, as

well as Juvederm, a product for enhancing facial skin.

The company expanded the 'Juvederm' range by introducing its variant Voluma, dermal fillers used in beauty clinics to

enhance facial aesthetics by treating folds and wrinkles.

Kumar said that the company is focused on creating awareness on the product by conducting educational campaigns

across the country as part of its marketing strategy.

Allergan currently markets its products from about 700 800 skin and beauty clinics across the country. Besides this, it also

has tie ups with beauty chains such as Kaya Skin Clinic and VLCC.

H1N1 vaccine in June:

Hindustan Times

Four Union health ministry funded H1N1 vaccines three injecting and one nasal pray will hit the market in June this

year, one year after H1N1 was declared a pandemic on June 11. The US and China had H1N1 vaccines ready in September

2009 and started vaccinations within a month.

Since India could not make its own vaccines in time, it had to import vaccines from Sanofi Pastuer, which arrived in

February 2010. By then, the worst of the H1N1 which has infected 31,904 and caused 1,527 deaths in India was over.

"Flu vaccines have never been manufactured in India, so we had to start from scratch by first building capacity and then

developing and testing the vaccine. Now that the capacity building is done, India can produce flu vaccines within months

of a new virus being identified," said Union Health Minister Ghulam Nabi Azad.

The health ministry funded H1N1 vaccines will hit the market in June and are expected to cost around Rs 180 per dose, a

fraction of the Euros 48 charged by the four MNCs Sanofi Aventis, CSL Ltd, Medimmune and Novartis manufacturing it.

Three companies Serum Institute of India, panacea Biotech and Bharat Biotech were given advance commitments of Rs

10 crore each by the health ministry to help them recover investment in building infrastructure and capacity.

"The price hasn't been finalised yet but it's expected to be Rs 180. Under the contract, all three companies have to quote a

price, the lowest of which will be chosen," said Azad.

If the companies want to sell at higher rates, have to back the advance commitment with market interest under an exit

clause.

Influenza viruses exist in many permutation and combination and constantly mutate. The viruses in the vaccine change

each year based on international surveillance and estimations by public health experts about which types and strains of

viruses will circulate that year. Each seasonal influenza vaccine contains three influenza viruses and it takes two weeks

after vaccination for a person to develop adequate antibodies to protect against infection.

There's hope for a next generation universal flu vaccine that provides some protection against all strains of influenza,

shows Italian research published in the open access journal mBio.

Surya Pharmaceutical to raise Rs 300 crore for its expansion plans:

Accord Fintech

Surya Pharmaceutical has received its board's approval to raise Rs 300 crore from domestic or international markets. The

said funds will be raised through issue of permissible securities for funding its new projects, expansions, diversifications,

acquisitions, other business expenses and to augment working capital requirements. The board has also decided to

convene an extra ordinary general meeting of the shareholders on June 30, 2010.The company is engaged in


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manufacturing of active pharmaceutical ingredients (API's), finished drug formulations (FDF's), fine intermediates, herbal

products, and mint/menthol derivatives.

Small pharma companies feel vulnerable to the increasing number of MNCs:

Accord Fintech

Increasing merger & acquisition activities in the pharma space is spreading shock waves among the domestic drug

manufacturers. Several small and medium players in the sector have decided to approach the government seeking

protection. The Union Health Ministry is also mulling to call a meeting of the pharma industry to discuss the issue of

increasing take overs of leading Indian pharma companies by MNCs. Pharma companies are concerned that the increasing

presence of MNCs could push up the drug prices going forward. The small and medium pharma companies are also

concerned that the rising number of MNCs and their scale of operation might influence government policy that would

eventually lead to elimination of the SME segment. MNCs have systematically made the government to implement

stringent rules like Schedule M and Good Laboratories Practices (GLP) and have crippled the small pharma companies.

Now the MNCs are crippling big pharma through the acquisition route. Moreover, the small drug manufacturers assert

that the staggering drug price rise in recent years was not only because of policies like MRP excise since 2005, but also

because the Drug Price Control Order (DPCO) inaction.

The SME Pharma Industries Confederation (SPIC) has written to the ministry of state, chemicals & fertilisers . Similarly, the

south India chapter of the Indian Drug Manufacturers' Association (IDMA) will approach the department of pharmaceuticals and the ministry of health & family welfare within a week. Besides, many of the state drug

manufacturer's organization are also contemplating taking up the issue with the government. The recent Abbott Piramal

$3.72 billion deal has raised concerns among pharma SMEs who fear similar corporate action in future which would

endanger their existence. Since 2008, the market has witnessed acquisitions of Dabur Pharma by Fresenuis Kabi, Shantha

Biotech by SanofiAventis, Ranbaxy by Daiichi Sankyo. The SMEs, which have close to 6,000 units, contribute 40% of the Rs

50,000 crore national drug production and have a 40% share in the exports. The SME associations are now getting vocal

about their concerns.

Cadila Healthcare's arm receives milestone payment from Abbott:

Accord Fintech

Cadila Healthcare's unit, Zydus Cadila, has received a milestone payment of $10 million from Abbott under the recently

concluded agreement between the two. Earlier this month, Zydus and Abbott had entered into an agreement for

commercialising branded generics in the emerging markets. As per the terms of the agreement, Abbott would license 24

branded generics of Zydus in 15 key emerging markets. The agreement also includes an option for additional 40 products

to be included over the term of the collaboration. The products for this engagement would be manufactured by Zydus at

its state of the art manufacturing facilities in India. Further, the alliance includes medicines for pain, cancer and

cardiovascular, neurological and respiratory diseases.

Indian drugs seized, Brazil complains:

EIU Viewswire

Brazil has filed a complaint at the WTO over the seizure by Dutch customs authorities of a shipment of Indian made

generic drugs. Brazil has asked the WTO to begin a formal consultation process involving the European Union and the

Netherlands. Brazils government has stated that the seizure broke WTO rules and risked disrupting the supply of generic

medicines to poor countries. India has also joined the request for consultation hearings at the WTO. The case relates to

the seizure in December 2008 of blood pressure drug losartan, the generic version of Merck & Cos Cozaar. Dutch officials

took a shipment which was developed jointly by Merck and EI du Pont de Nemours & Co (US) on the grounds of a patent

infringement complaint. The drugs, to treat 300,000 people for one month, had been exported by Indias Dr Reddys

Laboratories, which flew them back to India after customs released them.


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Ranbaxy plans to recall anti depressant drug from European market:

Accord Fintech

Ranbaxy is again in fix after its regulatory issues in the US market. This time it is its UK arm, owned by Japan's Daiichi

Sankyo, which has been asked to recall three lots of its anti depressant by the UK drug regulator Medicines and Healthcare

Products Regulatory Agency for not including safety warning mandated by the European Medicines Agency. The drug

regulator has also put the company's other drugs under review citing similar defaults in the past. The drugs in question,

which were distributed by Ranbaxy between May 2009 and March 2010, were about to expire between January and December 2012. The drug recall has been classified as class II type, the second level of severity, which mandates the

company to start acting within 48 hours. The company will recall its three lots of anti depressant drug Mirtazapine

(strength 15 mg and 45 mg), one each in UK, Denmark, and in Ireland. The company has already recalled all unexpired

stock of Sertraline Tablets 50 mg and 100 mg for the same reason and has reportedly said that these drugs have no quality

concern, while, the recall is being made in order to ensure corrective and preventive action and to update patient

information leaflets, to include safety warnings initiated by the European Medicines Agency.

Narayana Hrudayalaya Dental Clinic to invest Rs 150 Cr:

United News of India

Narayana Hrudayalaya

Dental

Clinic

(NHDC)

will

invest

Rs

150

crore

to

set

up

a chain

of

clinics

across

the

country

and

abroad, according to its Managing Director Dr Nitish Shetty. In a press release, he said the funds would be raised through

debt and internal accruals. The NHDC, which commenced operations in 2008, has seven clinics of which six are in

Bangalore and one in Kolkata. Dr Shetty said ''Our expansion plans will see us open 300 clinics by 2013 across India and

abroad. This will ensure dental facilities coming up across localities in the cities allowing easy and quick access to dentists.''

In India 98 per cent of the segment was dentist entrepreneur driven. Since dental health was of critical importance going

by its impact on cardiac diseases and diabetes, there was a need to expand dedicated facilities in the country. ''Therefore

our initial expansion plan is to roll out 30 clinics in Bangalore and Kolkata in the next six months,'' he added.

According to market reports, global dental care industry was estimated to be around US 18 billion dollar and the dental

equipment was pegged at US 15 billion dollar with a CAGR of five per cent and 4.5 per cent respectively. In India, the

dental care services market was estimated to be US 600 million dollar with a CAGR of ten per cent over ten per cent since

2000 and its equipment sector valued around US 90 million dollar. He said dental tourism formed ten per cent of total

Indian medical tourism, projected to grow at 30 per cent to Rs 9,500 crore by 2015. ''India produces more than 18,000

dentists annually from 283 dental colleges. The country has around 1,500 oral and maxillofacial surgeons,'' he said. The

General Dentist Concentration, according to Dr Shetty, was one dentist for every 30,000 persons. While urban

concentration indicated one dentist for every 10,000 persons, for the rural areas it was one dentist for every 2,50,000

persons.

Glaxo Plays Catch Up in Emerging Markets Land Grab:

Bloomberg

GlaxoSmithKline Plc plans to double revenue from India and China by 2015 as the drugmaker cuts prices to catch up to

Pfizer Inc., Sanofi Aventis SA and Novartis AG in emerging markets.

Glaxo aims to beat the industrys 12 percent to 14 percent growth in developing country sales, said Abbas Hussain, the

president for emerging markets at the London based company. Worldwide, drug revenue will increase at least 5 percent a

year through 2014, according to IMS Health Inc., which tracks pharmaceutical sales. The difference underscores the

importance of winning business in emerging markets, Hussain said.

Theres absolutely a land grab going on right now because obviously theres no growth in the U.S. and Europe, or very

little growth, Hussain, 45, said in a May 13 interview at Bloombergs New York headquarters. Theres a real fight on for

market share.


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Chief Executive Officer Andrew Witty hired Hussain, a 20 year veteran of Eli Lilly & Co., in 2008. Glaxos sales in emerging

economies have jumped by 50 percent since 2007 to 3 billion pounds ($4.3 billion) last year. Hes increasing the sales force

and snapping up smaller companies. Glaxo now has 13,000 sales representatives in emerging markets and will expand

further, especially in China, Hussain said.

Weve been playing catch up, particularly in China and Russia, with the likes of Novartis and the Sanofis and the

AstraZenecas, Hussain said. Glaxo is first among its peers in India, Pakistan and the Middle East, he said.

Ranbaxy, Lupin to benefit most from Japan's push for generics:

Mint

Two of India's top drug makers, Ranbaxy Laboratories Ltd and Lupin Ltd, would reap the maximum benefits from a

significantly large generic drug opportunity opening up in Japan, the world's second largest single drug market.

The direct link that these two firms have established in the Japanese market through cross border equity deals will likely

help them gain a significant market share in the emerging cheap drug segment in that country.

Daiichi Sankyo Co. Ltd, Japan's third biggest drug maker, acquired a 34.8% controlling stake in Ranbaxy in 2008 in a $4.6

billion (around Rs20,750 crore today) deal. Lupin acquired 80% of Kyowa Pharmaceutical Industry Co. Ltd in 2007.

Many other Indian companies including Dr Reddy's Laboratories Ltd, Torrent Pharma Ltd and Cadila Healthcare Ltd are still

struggling with their marketing set ups and business strategies in Japan's tightly regulated, $80 billion drug market.

Ahmedabad based Cadila Healthcare and Dishman Pharmaceuticals Ltd have set up subsidiaries in Japan.

The Japanese government is encouraging the use of cheap generic drugs as a large population of the elderly strains public

finances by causing it to spend more on social security. The government plans to convert at least 30% of the country's drug

prescription to lowcost generics by 2012. Currently, generic or off patent drugs have only a 17% market share in Japan.

"The Japanese market holds immense potential for global generic pharmaceutical companies like ours," said Nilesh Gupta,

group president of Lupin, who expects the generic drug market in Japan to grow at a "very fast clip". "The Japanese market

is a market of strategic focus for Lupin and we are the only Indian company and one of the few global generic pharma

companies to have built significant on shore presence in Japan through our subsidiary, Kyowa Pharmaceuticals, which is

now the fastest growing (among top 10 generic companies) in the Japanese market," Gupta said in an email response to a

query from Mint.

According to a research report, while the new generic drug focus of the Japanese government is expected to bolster Indian

generic drug firms in general, the Daiichi connection and Kyowa's established network would ensure easier market access

for Ranbaxy and Lupin.

A pharma analyst associated with a foreign brokerage present in India said that the help of a locally established parent or a

subsidiary is very important for a foreign drug maker in the Japanese generics market as drug regulations continue to be

stringent. "Lowcost generic drugs are still considered inferior in this strictly regulated, patented and branded drug

market," said this analyst, who didn't want to be identified.

Also, while the Japanese government plans to encourage the use of generic drugs, regulations have not been changed to

speed up their approvals.

Currently, Indian drug makers' revenues from the Japanese market are tiny compared with their sales in other regulated

markets such as the US and Europe. The strict regulatory regime and a low level of trust in foreign generic drugs among

patients and doctors have been key obstacles for Indian pharmaceutical firms in penetrating the Japanese market.


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Zydus Cadila receives Indian approval for swine flu vaccine:

Datamonitor Pharmaceutical & HealthWire

Zydus Cadila, an Indiabased pharmaceutical company, has received an approval from the Drug Controller General of India

to market the H1N1, or swine flu, vaccine which will be marketed under the brand name VaxiFluS.

VaxiFluS will be marketed by Vaxxicare, a division of the group focussing on preventives. The eggbased, inactivated vaccine based on conventional technology has been developed by the group's researchers at the company's vaccine

technology centre (VTC) in Ahmedabad.

VTC is further planning to develop a spectrum of vaccines against bacterial, viral and protozoal infections. The group also

markets the anti rabies vaccine and the typhoid vaccine, the company said.

Pankaj Patel, chairman and managing director of Zydus Cadila, said: "With the vaccine in the market soon, we would be

better prepared with an affordable therapy and prevent further loss of lives to this infectious disease. The launch of

VaxiFluS gives thrust to our objective of emerging as a strong player in the area of preventives."

Pharma exports seen growing at 8%:

Hindustan Times At the time when exports in other sectors witnessed a negative growth due to slowdown, pharmaceutical exports are

expected to register a growth of around 8 per cent in 2009 10. Based on the trends available so far, Pharmexcil

(Pharmaceutical Export Promotion Council) pegs the growth in the range of 48 per cent in 2009 10. Final figures regarding

the exports will be available in July.

"Considering the financial meltdown last year, it can be said Indian pharmaceutical sector has weathered the slowdown

well," said Smitesh Shah, chairman, Phamexcil. "Due to the slowdown, companies in importing countries used inventory

and avoided fresh orders," said Shah.

The Indian pharma sector has witnessed an average growth of around 810 per cent in last few years.

Taking the conservative side of the projection, export of drugs, pharmaceuticals and fine chemicals may touch $9,000 million (Rs 40,500 crore) in 2009 10. The export of was $8,610 million (around Rs 38,700 crore) in 2008 09, up 12.6 per

cent from the previous financial year. The export stood at $7,644 million in 2007 08.

The United States is the major driver of growth in export and accounts of around 1820 per cent of share in India's total

pharmaceutical export.

"The UK, Germany, Vietnam, Russia and Thailand are the other countries that have contributed to the growth of pharma

exports," said Shah.

Glenmark settles patent litigation with Merck:


India's Glenmark Pharmaceuticals has settled a patent litigation with Merck & Co over its cholesterol lowering generic drug 'Ezetimibe', following which the firm can sell the medicine in the US market.

Ezetimibe is a generic version of Merck Schering Plough's patented drug 'Zetia'.

Glenmark and Merck were fighting a patent litigation in the US court after the Indian firm had filed Abbreviated New Drug

Application with first to file status that entitled it a potential of 180 days of marketing exclusivity in the US.

"Under the agreement, Glenmark will be able to launch its product on December 12, 2016, or earlier under certain

circumstances, ahead of the April 25, 2017 expiration of Merck's patent exclusivity for Zetia," the company said in a

statement.


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This settlement effectively ends the lawsuit involving a challenge by Glenmark which sought to launch a generic version of

Zetia before the April 2017 expiration of the patent exclusivity covering Zetia, it added.

According to the industry experts, the development could give Glenmark an opportunity to earn around US$200 million

through the launch the drug in the American market with exclusivity.

Zetia has annual sales of around $1.4 billion in the US alone, a Glenmark spokesperson said.

Glenmark had filed an abbreviated new drug application with the US Food and Drug Administration seeking regulatory

approval on October 25, 2006, and the company had got the tentative approval for the drug last year through its USbased

subsidiary Glenmark Generics for Ezetimibe tablets in 10 mg strength.

Earlier this month, Glenmark had announced that it has signed an exclusive licensing agreement with the USbased Par

Pharmaceutical to sell Ezetimibe in the US market.

"Under the agreement, Glenmark has received a payment from Par for acquiring exclusive rights to market, sell and

distribute the product in the US," Glenmark has said.

The company, however, did not disclose the sum citing confidentiality clause.

Fortis Healthcare to raise funds Via FCCB Issue, Preferential Issue of Shares :

Stockmarketsreview.com Fortis Healthcare said that the company intends to raise funds up to $100 million through issue of 5% coupon Foreign

Currency Convertible Bonds having maturity period of five years and one day and convertible into equity shares at a

convertible price of Rs.167 per share. Religare Capital Markets PLC and The Royal Bank of Scotland N.V. are the joint book

runners to the issue.

The company also approved to issue about 22.35 million shares of Rs.10 each to Lathe Investment Pte. Ltd., an affiliated

investment vehicle of GIC Special Investments Pte. Ltd. at a premium of Rs.160 per share on preferential basis.

Astellas aims to emerge top player in transplantation:

Economic Times

Japans second largest pharma company, the $10 billion Astellas Pharma, intends to emerge as a niche player in India. The company plans to emerge as a market leader in the organ transplantation segment in five years and foray into newer areas

like urology and anti infectives with innovative molecules, a senior company official said.

Astellas floated a whollyowned subsidiary in India two years ago and launched its first drug, Prograf (generic: tacrolimus),

last month. It has plans to launch another drug in this segment, Advagraf, a modified version of Prograf, which has

received decent response in Europe and Japan.

Now that concerns around data protection have reduced in India, Astellas has big plans for expansion in India, said

Astellas Pharma India director (sales and marketing) Himanshu Dave. This includes market leadership in the Rs 160 crore

organ transplantation drug market and entry into newer therapeutic areas with innovative drugs, he said.

India is the fifth largest organ transplantation market with more than 4,200 kidney transplantations and 400 liver

transplantations in a year. Astellas expects when cadaveric transplantation becomes mainstream in India, it will help the

company to further consolidate its presence. This is despite the fact that Prograf has intense generic competition in India

from the likes of like Panacea Biotec and Emcure Pharma with medicines that are sold at 40% lower price.

There may be some 16odd generic products in the market, but we believe the innovator product will have a much bigger

appeal among doctors since the rest are all copies of it. Plus, we will focus on patient management and partnership with

leading hospitals to build a better transplantation practice, said Mr Dave.


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Astellas is undertaking market study to identify newer segments in India. It recently out licensed its anti fungal antibiotic

Mycamine to GlaxoSmithKline Pharmaceuticals (GSK) for the Indian market. However, GSK will retain the rights for

Mycamine for India even if we enter this segment, as it is a longterm deal, Mr Dave said.

Astellas is the second largest pharma company in Japan in terms of revenues, next to Takeda Pharma. It is followed by

other leading players like Daiichi Sankyo, which recently acquired a controlling stake in Ranbaxy, and Eisai Pharma. India is emerging as the next big focus area for the Japanese innovator pharma companies who have already gained significant

presence in regulated markets like the US and Europe.

Roche patent on Aids drug nixed:

DNA

The Chennai Patent Office has revoked a patent granted to Valcyte, Roche AGs drug that fights potentially blinding eye

infection among AIDS patients, three years after it was granted.

The move opens up the domestic market to cheaper versions of the drug, generically called valgancilovir.

This is the first time in India that a patent has been revoked by saying it was wrongly granted.

The revocation comes after patient groups and generic companies challenged the patent granted to the Swiss behemoth

in June 2007.

Roches drug did not meet Indias patentability criteria, sources said, including Section 3 (d) of the Indian Patents Act,

which says new forms of a known drug cannot be patented, unless they show enhanced efficacy over the existing one.

A Roche spokesperson told DNA the company is exploring all legal options.

The patent to Valcyte was challenged on the grounds that it was an improved form of a known drug called ganciclovir,

which was invented in the early 1980s, and hence does not qualify for a patent in India.

Valganciclovir is used to treat cytomegalovirus retinitis, an infection that people with HIV are susceptible to, and can lead

to blindness.Valcyte is priced at Rs 1,023 per tablet, while a copycat made by Cipla costs 76% less, or Rs 245 per tablet.

Patients are required to take two tablets twice a day for three weeks, then two tablets daily for 12 weeks, making it an

expensive treatment. If access to v

avendus pharma world june 2010

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