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KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2 nd Floor, Suryateja Apartments, Hindi Nagar, Punjagutta, Hyderabad, Telangana – 500078. Email: [email protected] . URL: www.Krisanibio.com Contact Number: +91 98494 33333.

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Page 1: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines

KRISANI BIO SCIENCES PVT. LTD.

Flat – B2, 2nd Floor, Suryateja Apartments, Hindi Nagar,

Punjagutta, Hyderabad, Telangana – 500078.

Email: [email protected] . URL: www.Krisanibio.com

Contact Number: +91 98494 33333.

Page 2: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines

Overview:

Krisani Biosciences is pioneering in rapidly and cost effectively design, develop,

and commercialize best-in-class innovative therapies for the treatment of

Copper toxicity (Wilson’s disease), Non-Alcoholic Steatohepatitis (NASH),

Neuropathic Pain, Cardiovascular Diseases, Cystinosis, Huntington's disease

and Hepatic Disorders; which can provide multiple benefits to patients, caregivers,

and consumers. Using our proprietary technologies was able to deliver unique

therapeutic molecules with enhanced safety and efficacy. The resulting new

molecular entities (NME) provide competitive advantage through product and

technology driven multiple layers of intellectual property protection such as

patents, trademarks and know-how; in addition to mitigating risks in various

stages of development and lowering regulatory hurdles.

Page 3: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines

Business Model:

KrisaniBio is an innovative biopharmaceutical company with a value driven

sustainable business model with highly differentiated, potential best in class

therapeutics to treat significant and life-threatening diseases.

We are committed to developing therapeutic products that we elieve best- in-class

with the potential to be more effective and safer products than the current

standard of care or other products in development. Our strategic approach to

drug development builds on internally and externally generated knowledge to

identify and develop proprietary and highly differentiated products, as well as

enables the company to limit development risks and costs.

By applying our distinctive technologies and capabilities, and by utilizing an

expeditious approach where possible to minimize development risk and costs,

we believe that we can create substantial value while being very cost effective.

Krisani Biosciences is focused to rapidly and cost-effectively design, develop and

out-license or collaboratively develop products by strategic alliances or

partnerships. Design, protection of the associated intellectual property and

development work will be carried out in Krisani Biosciences Private Limited. After

successful completion and validation of early stage proof-of-concept studies,

Krisani Biosciences leverages its assets for strategic collaboration or partnering

with multinational pharmaceutical companies to further develop and recognize

value or out-license the clinical candidate and set royalties and milestones,

thereby meeting projected revenues.

By maintaining a lean infrastructure, and working collaboratively with others,

including leading academic researchers, clinical centers, contract research

organizations, and contract manufacturing organizations, we are able to efficiently

and cost effectively advance multiple programs in parallel. As the product

development programs at Krisanibio continues to advance and mature, the

company intends to establish strategic alliances and collaborations in certain

areas with leading pharmaceutical and medical device companies. The primary

objective of such partnerships is to accelerate product development efforts, and to

maximize stakeholder value.

Page 4: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines
Page 5: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines

Research and Development:

KrisaniBio's R&D has built one of the strongest and broadest pipelines of potential

new candidates. We believe the pipeline has the potential to deliver value to

patients and payers and improve rates of financial return on our R&D investment.

The primary goal of our R&D function is to appropriately progress our pipeline

products safely and efficiently to deliver innovative new medicines.

KrisaniBio’s has a portfolio of products in the pipeline. The company allocates its R&D

investment with reference to the potential returns available from its target

therapeutic markets and the technical and commercial aspects, those factors are

reviewed at each phase of the development process and are central in the

decision to proceed to the next stage. At the centre of this strategy, we will focus

our molecules R&D and investments in Neuroscience Pain (Market potential: $29.8

Billion); Neurodegenerative Disorders ($19 Billion); Hepatology-($9 billion) and

Cardiovascular Diseases ($116 Billion).

KrisaniBio's pipeline is rich in Preclinical and first in human entries aimed at

important unmet medical needs such as Copper toxicity, NASH, Neuropathic

Pain; Liver Cirrhosis; Hypertriglyceridemia; Oncology, Cystinosis and Huntington's

Disease. With biomedical science Advancing on all fronts, we are aiming to work

more collaboratively with global clinical research and development organizations

and other pharmaceutical and biotech companies in ways that allow us to share

risk and gain access to new knowledge and technologies.

Page 6: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines

Intellectual Property

It is our policy to try to obtain patents on commercially important, protectable

inventions discovered or developed through our R&D activities. Patent

protection for new active ingredients is available in major markets and patents

can also be obtained for new drug formulations, manufacturing processes, medical

uses and devices for administering products.

Krisani Biosciences applies its proprietary drug discovery platform to identify

novel product candidates in a number of disease areas, including Wilson's

disease, NASH, Cardiovascular Diseases, Neuropathic Pain and

Neurodegenerative diseases. By applying our proprietary design platform, we

have discovered and advanced into pre-clinical trials a portfolio of three product

candidates targeting multiple diseases. To-date, the company is currently

working on 5 therapeutic areas and had granted 12 international and national

patents.

To-date, the company has filed one patent application on the novel diagnostic

technology and its applications in multiple disease areas with the United States

Patent and Trademark Office (USPTO) and Indian Patent Office (IPO).

Page 7: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines

Application Number Title Patent No. / Status

US20120022147 2,6 Xylidine Derivatives for the treatment of Pain US8283375B2

GRANTED

US20130225680A1 Compound, Composition and uses thereof for the

treatment of Hypertriglyceridemia US844570713B1

GRANTED

US20140221476A1 Compound, Composition and uses Thereof(Cystinosis) US8871805B2

GRANTED

2012-555510 Compound, Compositions, Formulations and their uses

thereof Granted,

Japan

221686 Compound, Compositions, Formulations and their uses

thereof Granted,

Israel

2011-222649 Compound, Compositions, Formulations and their uses in

the treatment diseases related to copper retention or Hepatic Disorders

Granted, Australia

11731488 Compound, Compositions, Formulations and their uses

thereof Granted,

European PO

2013-513777 Cysteamine Derivatives and their use in the treatment of NASH (FR) derives Cysteamine ET LEUS utilisation DANS

LE treatment DESTEATOPATHIES NON ALCOOLIQUES

Granted, Japan

2011-263423 Cysteamine Derivatives and their use in the treatment of

NASH Granted, Australia

2580204 Cysteamine Derivatives and their use in the treatment of NASH (FR) derives Cysteamine ET LEUS utilisation DANS

LE treatment DESTEATOPATHIES NON ALCOOLIQUES

Granted, European PO

223241 Cysteamine Derivatives and their use in the treatment of

NASH Granted,

Israel

201303972-2 Method and System for Prognosis and Treatment of

Diseases using Portfolio of Genes Granted,

Singapore

Page 8: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines

Pipeline Profile:

KB-HD-01: Wilson’s disease:

A novel prodrug and a novel Copper metal chelator with Significant Superior

Pharmaceutical Profile compared to the marketed drugs. Potent Copper Chelator

cum Antioxidant Lead and has better Drug Profile than D-Penicillamine with

Neuroprotective Properties. Presently chemical synthesis completed and pre-

clinical data is encouraging towards proof of concept studies.

KB-GE-001:Non-Alcoholic Steatohepatitis (NASH):

A novel Co- drug for liver cirosis and exhibits multiple fold activity than the marketed

drugs. Chemical synthesis completed and preclinical work under progress

KB-CN-01: Neuropathic Pain:

A novel prodrug of a local anesthetic that alters signal conduction in neurons by

blocking the fast voltage gated sodium (Na+) channels in the neuronal cell

membrane; Longer duration of action with enhanced pharma cokinetics, safety

and efficacy; Enhanced neural blood flow, conduction and glucose transport.

Currently in the advanced Pre-clinical stage. The product portfolio has the potential

for the treatment of Diabetic Neuropathy, Post-Herpetic neuralgia, Chronic Pain,

Spinal Cord Injury and Peripheral Neuropathy. A US Patent has been granted

US8283375B2 in the Month of October 2012.

KB-CV-001: Hypertriglyceridemia:

A novel new molecular entity (NME) of Eicosapentaenoic acid. KB-CV-001 is an

ULTRA-PURE form of EPA (Eicosapentaenoic acid) in an ESTER form and when

compared to the US-FDA recently approved entity, Amarin Plc’sEPA ester

(VASCEPA) product which claims to have above 96% pure EPA Ester only, whereas,

KB-CV-001 EPA analytical purity was found to be 99% and has a greater potential.

KB-CV-001is also a derivative of an endogenous compound, 2-aminoethanethiol

and is a Chemically Highly Stable compound.

KB-ND-01: Huntington’s disease (Orphan category):

A novel prodrug of Potent Trans glutamase inhibitor, Neuroprotection by

increasing brain derived neurotrophic factor (BDNF) levels, Long duration of action

with enhanced pharmacokinetics, tolerability, safety and efficacy, Potential to

penetrate through Blood-Brain Barrier and stabilizes the neural membrane.

Currently in the advanced Pre-clinical stage. The product portfolio has also the

potential for the treatment of Nephropathic Cystinosis, Hypertriglyceridemia and

Non- alcoholic Steatohepatitis (NASH).

Page 9: KRISANI BIO SCIENCES PVT. LTD. · KRISANI BIO SCIENCES PVT. LTD. Flat – B2, 2nd Floor, Suryateja Apartments, ... products safely and efficiently to deliver innovative new medicines

Creating a successful and sustainable business is

about more than financial results. We place

great importance not just on what we achieve but

on how we achieve it. Running a responsible,

values-based business is embedded in our

strategy.