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One of the most ambitious projects of Biocon - the development of oral insulin - is expected to be delayed further. The Bangalore-based company which is attempting to develop this drug for the past few years - first on its own and for the past one year with global pharmaceutical major Bristol Myers Squibb (BMS), is expected to pick up talks with BMS on the future of the project going further.
This move may be precipitated by the last week's decision by BMS to exit a joint venture for diabetes with Astra Zeneca for close to $4.3 billion. Upon completion of the transaction, AstraZeneca will own intellectual property and global rights for the development, manufacture and commercialisation of the diabetes business, which includes Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin HCl extended release), Komboglyze (saxagliptin and metformin HCl), dapagliflozin (marketed as Forxiga outside the US), Byetta (exenatide), Bydureon (exenatide extended-release for injectable suspension), metreleptin and Symlin (pramlintide acetate).
This move by BMS to exit the joint venture in the diabetes segment is expected to come as a setback for Biocon. Kiran Mazumdar Shaw, CMD, Biocon told Business Standard that she is yet to be hear from BMS on how they want to proceed with the oral insulin project and hence would not want to comment on the future of the same. During November last year, Biocon had signed co-development partnership with BMS aiming to leverage the positive data obtained from the Indian Phase III study. However, industry analysts indicate that Biocon's oral insulin project will be delayed further due this.
The project - IN 105 - has had a rocky path in the recent past as well as the aspect of increased hurdles for clinical studies in India.
Biocon had previously conducted a Phase III study in India with IN-105, which did not meet its primary endpoint. However, all secondary endpoints were met confirming IN-105 behaves like a prandial insulin by significantly reducing blood glucose levels during and after meals. "Furthermore, IN-105 has been shown to mimic the natural physiology of the body by targeting the liver which is a central organ in glucose metabolism. This results in lowering the risk of hypoglycemia, when blood sugar levels fall to abnormally low levels, and also prevents weight gain," Biocon earlier said in a statement.
