Biocon Ltd, on Friday, said it had signed an ‘option’ agreement with U.S. drug major Bristol-Myers Squibb Company to develop — and later market — its ambitious oral insulin candidate drug.
Bristol-Myers Squibb (BMS) would now fund the development of the drug, codenamed IN-105, through Phase II trials. Depending on the result of the clinical trials, it would have an exclusive option to further develop and commercialise the candidate, according to a company release.
Biocon would retain exclusive rights to IN-105 within the country. Phase II trials may take up to two years, a company spokesperson said.
The drug is expected to help diabetics relieve the pain of their daily insulin injections.
BMS and Biocon are old partners; the U.S. company started its dedicated R&D (research and development) centre at Biocon's Syngene over three years ago.
BMS “will have the right to exercise an option to obtain an exclusive worldwide licence to the programme. Biocon will conduct clinical studies to further characterise IN-105’s clinical profile according to a pre-agreed development programme up to the completion of Phase II,” the release said.
Biocon's Chairman and Managing Director, Kiran Mazumdar-Shaw, said: “This agreement is one huge step closer to bringing oral insulin to market.”
If BMS decides to license IN-105 after Phase II trials, it would be fully responsible for its development and marketing outside the country.
Biocon would receive a licence fee in addition to potential regulatory and commercial milestone payments and royalties on commercial sales of IN-105 outside India.