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Publicly-held biotechnology major Biocon Ltd on Friday announced it had entered into an agreement with the US-based $21-billion Bristol-Myers Squibb (BMS) to further develop its IN-105, an oral insulin product candidate.
Biocon will use BMS' expertise in clinical trials and get help in redesigning Phase-II trials of the blockbuster drug. Biocon has been working on this drug since 2004 and has so far spent close to $20 million. It had started the programme by partnering US-based Nobex, but later taken control as the latter declared bankruptcy in late 2005.
BMS has a strong presence in the diabetes segment, but in the space of drugs that enable delay in insulin intake. As the partnership goes further, it will possibly mark its entry into the insulin space.
Oral insulin is a drug that has been elusive for many players globally. Only a handful of global majors, including Novo Nordisk, are working in this space. When this product comes into the market , it will bring about a big change, not only to the companies but also the millions of diabetics who have to go through the pain of injection pricks very frequently.
"While there are difficulties in developing an oral insulin, the principle aspect is that insulin is a difficult drug to ingest orally. It is a protein that degrades in the stomach and small intestine. This makes it difficult to design oral delivery. So, companies have to work on mechanisms on how to protect this protein in the human system until it starts to work," an industry analyst detailed.
Biocon, too, had stumbled on its trials in early 2011, when the initial data analysis showed IN-105 did not meet its primary end point of lowering the average level of blood sugar by 0.7 per cent.
Under its agreement with Biocon, 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. "BMS will invest a substantial majority in our Phase-II trials, while there will be some contribution from us as well," Biocon CMD Kiran Mazumdar-Shaw said. Industry analysts indicated Phase II trials in such scenarios would cost around $15 million.
The Phase-II trials will be spread over two years and there will subsequently be Phase-III trials for around three years, during which there will be pivotal and multiple tests.
If Bristol-Myers Squibb exercises its option to license IN-105 following the successful completion of the Phase-II trial, BMS will assume full responsibility for the programme, including all development and commercialisation activities outside India.
Biocon will receive a licence fee in addition to potential regulatory and commercial milestone payments and royalties on commercial sales of IN-105 outside India. Biocon will retain exclusive rights to IN-105 in India.