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Biocon and Quark Pharmaceuticals Collaborate to Develop Novel siRNA based Therapeutics

Bangalore, India, and Fremont, CA, December 18, 2013

Biocon Ltd, Asia's premier biotechnology company, and Quark Pharmaceuticals, Inc,. a world leader in the discovery and development of siRNA-based therapeutics, announced today that they have entered into a Licensing & Collaboration agreement for the development of a range of siRNA (small interfering RNA) based novel therapeutics.

This collaboration will enable Biocon to co-develop, manufacture & commercialize QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other key markets.

Biocon will have access to Quark’s innovative and proprietary siRNA technology platform that can be leveraged for the development of novel therapeutics for various unmet medical needs.

QPI-1007 is being developed for ocular neuroprotection in NAION (non- arteritic anterior ischemic optic neuropathy) and acute angle closure glaucoma. It has completed a phase I/IIa first in human, open label, single-dose, dose escalation, safety, tolerability and pharmacokinetic study conducted at 16 centres in the USA and 5 centers in Israel. The study showed QPI-1007 was safe and exhibits strong neuroprotective activity in NAION patients.

Glaucoma is a slowly progressing optic neuropathy characterized by the progressive loss of retinal ganglion cells(RGCs) and is the leading cause of blindness worldwide. The nerve damage and visual loss from glaucoma is usually irreversible. Neuroprotection has been proposed as a therapeutic strategy in glaucoma to promote survival of retinal ganglion cells.

In India, it is estimated that glaucoma affects 12 million people accounting for 12.8% of the country’s blindness and by 2020, this is expected to reach 16 million. Population-based studies report a prevalence between 2 to 13 % in India, and more than 90 per cent of glaucoma in the community is undiagnosed. Statistics say 1 in 8 persons above the age of 40 years in India is either suffering from glaucoma or is at risk of the disease. Over 2.5 million people are detected with primary angle closure glaucoma. Glaucoma can affect any age group, including newborn, infants, children and elderly. (Source: Glaucoma society of India, Research paper SankaraNethralya)

Commenting on this development Ms Kiran Mazumdar Shaw, Chairperson & Managing Director, Biocon, said: "We are very excited to partner with Quark to develop novel and promising siRNA therapeutics. Quark is the world leader in this technology and our joint development efforts on QPI-1007, targeting ocular neuroprotection aims at providing relief to several patients suffering from serious ophthalmic conditions. This collaboration reinforces our commitment to develop and introduce innovative therapeutics to India to meet the unmet medical needs. We hope to use this technology for developing several other novel therapeutics."

“We are very pleased to collaborate with Biocon Limited, a pioneer in biopharmaceuticals. It is the only Indian company to develop several difficult to make biologics and biosimilars and has provided affordable healthcare solutions for the patients in India and other markets. We believe siRNA is going to make a very important impact in the field of pharmaceuticals discovery and development. We are hopeful that this collaboration will position Biocon as the leading siRNA company in India and as an international player in this new drug category.” said Daniel Zurr, Ph.D., CEO,QuarkPharma.

An expert team of scientists from Quark and Biocon will jointly work on the development of QPI-1007, and the additional novel pipeline, leveraging the siRNA innovative technology.

Financial terms were not disclosed.

Notes to the Editor:

Novel Technology
RNAi technology is used to interfere with the expression of a specific gene. RNA interference (RNAi) has broad potential as a therapeutic to reversibly silence any gene. To achieve the clinical potential of RNAi, delivery materials are required to transport short interfering RNA (siRNA) to the site of action in the cells of target tissues.

About QPI-1007 QPI-1007 is a synthetic siRNA designed to temporarily inhibit expression of the pro-apoptotic protein, Caspase 2. QPI-1007 utilizes a novel siRNA structure developed by Quark that preserves activity while attenuating off-target and immunostimulatory effects. QPI-1007 is being developed as a neuroprotectant for the treatment of non-arteritic ischemic optic neuropathy (NAION) and potentially other optic neuropathies such as glaucoma that result in the death of retinal ganglion cells (RGCs).

Apoptosis (programmed cell death) is thought to be the main cause of the death of retinal ganglion cells. Quark believes that QPI-1007 may be an effective neuroprotective agent, with potential use in NAION and also in major diseases involving retinal ganglion cell loss, including glaucoma.

About Biocon

Established in 1978, Biocon Limited, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and Asia’s leading biotechnology company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patients worldwide. Biocon's robust product portfolio includes the world's first Pichia-based recombinant human Insulin, INSUGEN®, Glargine, BASALOG® and India's first biologic BIOMAb-EGFR® for head & neck cancer. It has now successfully developed its second novel biologic Itolizumab, a ‘first in class’ anti-CD6 monoclonal antibody, introduced as Alzumab for psoriasis in India, in 2013. For additional information pl visit: www.biocon.com

About Quark Pharmaceuticals, Inc.

Quark Pharmaceuticals, Inc., the world leader in novel RNAi discovery and development, has the largest clinical-stage siRNA pipeline in the industry. The Company’s fully integrated drug development platform spans therapeutic target identification to drug development. Quark’s approach to delivery allows targeting of tissues and organs including the eye, kidney, ear, lung, skin, spinal cord and brain.

Quark has a rich pipeline of siRNA drug candidates in six different indications, which completed proof of concept in a variety of animal models conducted by renowned opinion leaders. It has three product candidates in clinical development in five different indications of which four are in phase II and one in phase IIb.

Quark is headquartered in Fremont, California and operates research and development facilities in Boulder, Colorado and Ness-Ziona, Israel.

For additional information pl visit: www.quarkpharma.com

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