The company plans to acquire a global partner to carry the failed research forward.
Biotechnology firm Biocon’s ambitious oral insulin project has failed to live up to its hype, casting doubts over the drug’s entry into the market in the near future.
In a trial involving 264 patients conducted at various centres across India, the molecule IN 105 failed to meet the primary goal of reducing HbA1c levels by 0.7%. HbA1c helps indicate blood glucose levels.
According to the company, the molecule, however, did meet parameters concerning safety and efficacy, and further assessment of the data is going on. Kiran Mazumdar-Shaw, chairperson and managing director of Biocon, said the company will continue global development of the molecule by partnering a global company, for which discussions will be initiated.
Dr AK Jhingan, chairman of the Delhi Diabetes Research Centre, said reducing HbA1c is the primary objective. “If that key objective is not met, then what is the point of bringing out a product which will be costlier than existing insulin, which most patients are already used to?”
According to a Mumbai diabetologist, medical community, although excited about non-injectable methods of delivering insulin, is highly wary about actually prescribing such products.
“So many patients are on insulin. It’s a tough call for doctors to actually ask patients to use insulin in a different format when little is known about its side-effects in the long run,” he said. A pharmaceutical industry expert said the talk of continuing further development, post finding a global partner, should be taken with a pinch of salt. “Which global firm will come forward and be ready to partner this project where the risks are so high? Without a partner, it’s impossible at a financial level to continue with the development.”
Ranjit Kapadia, vice president, institutional research, HDFC Securities, said there are no major upsides from this result. “They used the product along with another diabetes product metformin. There is a need for studies on how it works as a singular product and in a larger patient population.”
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