Biocon, Bentley Pharma in product licensing pact

Pharma major Biocon has signed a product licensing agreement with Bentley Pharmaceuticals, a speciality pharmaceutical company in Europe, for the latter's 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.

Bentley has also signed a long-term insulin raw material (API) sourcing agreement with Biocon. The API sourcing arrangement would provide Bentley and its licensees, with a competitive supply of insulin from Biocon for worldwide markets.

Also, Biocon and Bentley 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 rest of the world.

The two partners will share the cost of clinical development and regulatory filings in their respective territories. However, the terms of the agreement were not disclosed.

Biocon chairperson and managing director Kiran Mazumdar Shaw, said that her company believed that non-injectable insulins will drive the future of diabetes therapy.

"Along with our own program 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. As one of the largest producers of insulin, this cooperation is of great strategic importance to us," she added.

At present, Biocon has a broad product portfolio of recombinant biotherapeutics, statins and immuno-suppresants.

Biocon and its two subsidiary companies""Syngene International and Clinigene International form an integrated biopharmaceutical company, specializing in custom research, clinical research, biopharmaceuticals and enzymes.

With initiatives in clinical development, bioprocessing and global marketing, Biocon currently delivers products and solutions to partners and customers across 50 countries.

The company's several products have already been approved and registered in the Europe and the US.

Bentley chairman and chief executive officer James R Murphy said that since Biocon has had several years of experience in the development and manufacturing of various dosage forms of insulin and research in oral absorption, it is a very valuable and experienced strategic partner for Bentley not only providing a consistent source of insulin, but highly experienced in insulin development and regulatory expertise through its wholly""owned 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," he added.

Murphy added that Bentley had secured a regulatory approval to continue its clinical development program and initiate the first study in Asia. Clinical supplies have already been produced utilising Biocon's raw material and the studies will begin shortly, he informed.

Bentley Pharmaceuticals is a specialty pharmaceutical company focused on advanced drug delivery technologies and pharmaceutical products. Its proprietary drug technologies facilitate absorption of pharmaceutical compounds across various membranes.

Bentley 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""Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary""Bentley API.