Biotech major Biocon has signed an option agreement with Bristol-Myers Squibb Company for Biocon's IN-105, a prandial oral insulin product candidate.
"We had a setback in terms of a placebo effect. We are now trying to redesign and conduct a few trails to basically establish the ethicacy of the drug. This is an important step towards major licensing deals, which will only get triggered once get the outcome of these initial trails," Kiran Mazumdar-Shaw, MD and Chairman of Biocon told CNBC-TV18.
Under the terms of the agreement, Bristol-Myers Squibb will have the right to exercise an option to obtain an exclusive worldwide license to the program. Biocon will conduct clinical studies to further characterise IN-105's clinical profile according to a pre-agreed development program up to the completion of Phase II.
"If the drug works like the way Bicon believes it will should, then it is a blockbuster in the making," Shaw said.
At 09:24 hrs shares of Biocon were quoting at Rs 312.90, up Rs 6.10, or 1.99%.
Below is the edited transcript of Kiran Mazumdar-Shaw’s interview with CNBC-TV18.
Q: Could you just walk us through the contours of the deal in terms of what it involves on a license fee and the one time development fees as well that you have referred to in your release?
A: No, I would like to basically manage expectations. This is an Option agreement, which gets us to restart the clinical trial for which we had a setback in terms of a placebo effect. What we are now doing is to redesign and conduct a few trials to establish the efficacy of the drug.
Certainly, this is a very important step towards major licensing deal, which will only get triggered once we get the outcome of these initial trials. These are early days yet. All it says is that the drug continues to hold very good promise. The big announcement will only come once it triggers the licensing deal.
Q: How soon do you expect to have clarity though on whether this is successful for phase II or not?
A: It will take atleast one and a half to two years before we get any data to demonstrate it efficacy.
Q: What is the potential of this drug sells outside India? Could you give us any ballpark figure that we could work with?
A: If a drug works like the way we believe, it should then it is a blockbuster drug in the making because it is a huge opportunity for transforming the way diabetes is treated and that is what we are trying to establish.
Indeed the early findings and the all the kind of secondary end-point seems to suggest that this drug is certainly very efficacious and it does what it is supposed to do. But the design of the trial was such that it did not quite bring out the true benefit of the drug and that is what we are redesigning in these next set of trials.