Biocon's oral insulin hinges on global partner

BANGALORE: Though Biocon's much-awaited oral insulin drug failed to meet the primary goal in its Phase III clinical trials in India, several analysts are hopeful that the company will be able to take the research further and bring the drug eventually to market.
Dipta Chaudhury, programme manager for the healthcare practice in research firm Frost & Sullivan, said that a drug reaches Phase III of clinical trials only after a certain level of efficacy is proved."I think it's a good product. All trials have proved it's safe, that it has no side effects. May be they have to increase the dosage or tweak some things," she said.
N Suresh, group editor of biotechnology publication BioSpectrum, said it's possible that the particular trial methodology that Biocon adopted may not have worked. "Now that they intend to partner with an international pharma company, the partner may have something that can provide different results," he said.
Biocon CMD Kiran Mazumdar-Shaw said on Tuesday that the company would continue the drug's development and start discussions with a global pharmaceutical partner.
Biocon has been conducting research and trials on an oral insulin candidate called IN-105 since 2001. Insulin currently needs to be injected by diabetics. But that's an inconvenient way of administering it on a daily basis. An insulin tablet is a potentially transformative product, so Biocon has a lot riding on this product.
Biocon said on Tuesday that in the Phase III trials, IN-105 did not meet the target of lowering the level of glycated haemoglobin by 0.7% compared with a placebo. The level of glycated haemoglobin in the body is an indication of the effectiveness of a drug to control blood sugar levels.
The company indicated that the failure to achieve the goal may not have anything to do with the effectiveness of the drug but may have been the result of patients on the placebo modifying their behaviour during the course of the study. The suggestion is that those on the placebo changed their diet and lifestyle in a way that brought down their sugar levels. Such changes are sometimes attributed to inaccurate design of the clinical trial. Biocon also said that secondary targets on efficacy and safety had been met.
Dr Vivek Shenoy, DGM in Biocon, said a failure in a clinical trial does not mean that the drug itself has failed. "You learn from trials, and use those learnings to design a new trial differently, may be with other kinds of patients, population groups," Shenoy, who has been in the pharma industry in the US for 25 years, said.
The future of the drug now seems to depend on Biocon's ability to convince a global pharma major to bring in the money required to do international trials. Such trials will cost over $150 million, something that Biocon cannot afford on its own.
Mazumdar-Shaw is currently in the US wooing partners. She disclosed the latest details of the oral insulin drug at the JP Morgan Healthcare Conference that is currently on in San Francisco. Last year, she convinced global pharma major Pfizer to enter into a $350 million deal to market Biocon's insulin drugs globally. Clearly, confidence in Biocon is high.
Chaudhury of Frost & Sullivan says it's a smart move to get an international partner. "They will have to share the profits. But that's the best way to go," she said.