Biocon Limited has entered into an option agreement with Bristol-Myers Squibb (BMS) for its IN-105, a prandial oral insulin product candidate. Under the terms of the agreement, Bristol-Myers Squibb will have the right to exercise an option to obtain an exclusive worldwide license to the programme. Biocon will conduct clinical studies to further characterize IN-105’s clinical profile according to a pre-agreed development programme up to the completion of phase II.

If Bristol-Myers Squibb exercises its option to license IN-105 following the successful completion of the phase II trial, it will assume full responsibility for the development programme, including all development and commercialization activities outside India. Biocon will receive a license fee in addition to potential regulatory and commercial milestone payments and royalties on commercial sales of IN-105 outside India. However, the Indian biotechnology major would  retain exclusive rights to IN-105 in India.   

“This agreement is one huge step closer to realizing the dream of bringing oral insulin to market.  We are excited to extend the excellent relationship we already enjoy with Bristol-Myers Squibb, and look forward to working closely with them to make this a reality, said Kiran Mazumdar-Shaw, MD and chairman of Biocon

Diabetes is a chronic disease that affects about 350 million people worldwide.   Long-term complications of diabetes include cardiovascular complications, peripheral vascular disease (leading to and including amputation), kidney failure, and other chronic diseases.  It is estimated that the direct and indirect costs of diabetes to the overall healthcare system amount to over $650 billion worldwide.

Balancing its novel molecule research pipeline with a diversified product portfolio, Biocon delivers affordable solutions to partners and customers in over 75 countries across the globe. Many of these products have US FDA and EMA acceptance. Stellar products from Biocon’s stable include the world’s first Pichia-based recombinant human insulin, insugen and glargine, Basalog coupled with a state-of-the-art insulin pen device, InsuPen and India’s first indigenously produced monoclonal antibody BioMAb-EGFR. With a team of over 6500 employees, the company has been recognized amongst the ‘Top 20’ Global Employers in biopharma sector in September this year.