Biocon Limited, India's biotechnology major has signed a product licensing agreement with Bentley Pharmaceuticals, Inc. for development and marketing of an intranasal spray formulation for administering insulin. The license agreement covers 85 countries granting Biocon exclusive as well as co-exclusive rights to develop and market throughout Asia, Africa, and the Middle East.

The long term supply agreement with Biocon will provide Bentley, and its licensees, a competitive supply of insulin for worldwide markets.

The two companies will work together in the clinical development of the intranasal insulin product to meet the requirements of various international regulatory authorities including USA, EU and ROW. The two partners will share the cost of clinical development and regulatory filings in their respective territories. The specific terms of the agreement were not disclosed.

"Biocon believes that non injectable insulins will drive the future of Diabetes therapy. Along with our own programme in oral delivery of insulin, this development agreement will give us the breadth of opportunity to straddle the entire domain of non injectable insulin delivery. Biocon has made a large commitment to the insulin segment and this cooperation is of great strategic importance to us," stated Ms. Kiran Mazumdar Shaw, chairman and managing director Biocon Ltd.

According to James R. Murphy, Bentley's chairman and CEO, the company has teamed-up with one of the world's largest producers of insulin. "We look forward to shaping an aggressive plan to develop the product for commercialisation. Biocon has had several years of experience in the development and manufacturing of various dosage forms of insulin and research in oral absorption. As a valuable and experienced strategic partner for Bentley, Biocon will not only provide a consistent source of insulin, but highly experienced in insulin development and regulatory expertise through its wholly-owned and accredited clinical research organisation, Clinigene. We believe that this collaboration has laid a foundation that will significantly support the strategic developmental and commercial objectives of Bentley," Murphy added.

Bentley expects to receive imminent regulatory approval to continue the clinical development programme and initiate the first study in Asia. Clinical supplies have already been produced utilising Biocon raw material and the studies will begin shortly.

Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and pharmaceutical products. The company's proprietary drug technologies facilitate the absorption of pharmaceutical compounds across various membranes. It also manufactures and markets a growing portfolio of generic and branded pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries, Laboratories Belmac, Laboratories Davur and Laboratories Rimafar; and manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.