January 24, 2008 Ahmedabad, India and Monmouth Junction, NJ - Zydus Cadila, an innovative global pharmaceutical company, and Prolong Pharmaceuticals Inc., a US-based, venture-backed drug delivery research and development company, have announced the collaboration for the development of a next generation therapeutic protein, ‘PEG-EPO’, for the treatment of severe anemia.
Severe Anemia, is a condition where the hemoglobin (Hb) level or number of circulating red blood cells (RBCs) is significantly reduced. This is common in chronic renal failure (CRF), cancer patients undergoing chemotherapy, some chronic inflammatory diseases, heart failure, surgical settings and critically ill patients. The first generation drug, EPO, did wonders to the treatment of this condition. However, new advances in therapy can improve EPO’s therapeutic profile, offer greater convenience, and lower treatment costs. PEG-EPO promises to be a third generation drug.
The Zydus-Prolong pact seeks to increase productivity in the drug development of this next generation therapeutic protein by leveraging the combined strengths of both companies. As per the agreement, both companies will utilize Prolong’s differentiated PEGylation technology to make PEG-EPO. This joint development will help in developing an optimized drug candidate with improved therapeutic properties. Both partners will also be equitably sharing risk and reward for this collaborative programme.
PEGylation is the only FDA-approved protein delivery technology that transforms proteins into superior drug products, by attaching a polyethylene glycol (“PEG”) polymer to a therapeutic protein. This process results in an improved product with significantly enhance potency, fewer side effects, and a reduced dosing frequency.
Zydus Cadila will leverage its expertise in carrying out a focussed drug development programme, starting from pre-clinical candidate selection, filing of the Investigational New Drug, undertaking pre-clinical studies and human clinical trials and marketing it in mutually agreed upon territories globally. The collaborative programme will bring an edge to Zydus’ global biologics strategy with the introduction of an improved biologic product.
“Prolong is excited about this unique development partnership with Zydus, given their focus and strong in-house capabilities on drug development,” commented Dr. Abe Abuchowski, President and COO. “This collaboration will also enable Prolong to capitalize on the cost effective drug development capabilities that India offers.” YES Bank was the strategic advisor to Prolong for the transaction.
Speaking on the occasion, Pankaj Patel, Chairman and Managing Director Zydus Cadila, mentioned “This deal marks Zydus’s foray into the area of novel improved biologicals. There is a strong unmet medical need in this space, and we are committed to discover, develop and provide better as well as safer alternatives to patients at affordable prices.”
About Zydus Cadila Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group’s operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India with subsidiaries in USA, Europe, Japan, South Africa, Brazil, the group has a global presence and reaches out to people in over 60 countries worldwide. In its mission to create healthier communities globally, Zydus Cadila delivers wide ranging healthcare solutions and value to its customers. With over 8,000 employees worldwide, a world-class research and development centre dedicated to discovery research and nine stateof- the-art manufacturing plants, the group is dedicated to improving people’s lives.
About Prolong Pharmaceuticals Prolong Pharmaceuticals is advancing the art of PEGylation for the Biopharmaceutical Industry. Dr. Abuchowski developed the science of PEGylation and with his current team at Prolong, developed the first three PEGylated products approved by the FDA. Management recognizes that there is no one PEGylation chemistry or strategy that will work on all products and is therefore applying its considerable history of know-how and trade secrets to develop new PEG-products with improved biological activity, ease of manufacture and low cost of goods. This will allow the company to effectively compete with its products in the world market. The company has three products in development and is actively searching for new product/relationships. The Company has been financed by KBL Healthcare Ventures.
Contact: Dr. Zachary Berk Chairman & CEO Prolong Pharmaceuticals (917) 596-7393 Dr. Abraham Abuchowski President & COO Prolong Pharmaceuticals 732-438-1133 Corporate Communications: Cadila Healthcare Ltd. Zydus Tower, Satellite Cross Roads, Ahmedabad – 380015, Gujarat, INDIA Tel: +91-79-26868353 Fax: +91-79-26862365
