Biocon Ltd, and Quark Pharmaceuticals, Inc., a world leader in the discovery and development of siRNA-based therapeutics, have entered into a licensing and collaboration agreement for the development of a range of siRNA (small interfering RNA) based novel therapeutics. The financial terms were not disclosed.

This collaboration will enable Biocon to co-develop, manufacture and 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 five centres 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 per cent 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 per cent in India, and more than 90 per cent of glaucoma in the community is undiagnosed. Statistics say one in eight 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 according to a SankaraNethralya research paper.

“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, said Ms. Kiran Mazumdar Shaw, chairperson and managing director, Biocon.

“We are very pleased to collaborate with Biocon and it is the only Indian company to develop several difficult to make biologics and biosimilars 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 Dr Daniel Zurr, 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.