Ltd will conduct on its own the next phase of clinical trials
of its oral insulin Tregopil
with a larger patient pool including in India, as the company expects the drug, after regulatory approvals, would offer it licensing opportunity to global drug firms.
India has around 69 million of the 414 million diabetes patients
globally, according to the International Diabetes Federation.
had partnered with British drug maker Bristol Myers Squibb (BMS) for the initial clinical studies in the US on insulin Tregopil
under a US investigational new drug application (IND) that yielded positive results. Since then, BMS
had hived off its diabetes franchise to AstraZeneca.
"The initial round of studies, which were conducted on about 100 subjects, have demonstrated fast action of Insulin Tregopil
with distinct properties compared to other prandial insulins like Aspart,” said Kiran Mazumdar Shaw, chairperson and managing director of Biocon.
"We cannot discuss specific timelines for the next phase of clinical studies, but suffice to say that we have assembled a world renowned group of endocrinologists and diabetologists to work with us to drive the development of this important molecule.”
plans to spend around 10-12% of its Biopharma
revenues on research and development on drugs. In the October to December quarter, it spent Rs 91 crore on R&D.
Typically, a new drug development costs around $1 billion for Pharma companies
said that it has rationalised products in its branded formulations and focused on higher margin products in the Indian market.
“Our endeavour is to make sure these key brands grow faster than the current pace so that they make up for the rationalized products. e.g. in our flagship segment, we have held a steady 10% market share in represented insulins market and have strengthened our offering recently with Basalog One, a ready-to-use disposable device for glargine an insulin analog," Shaw said..
The firm said its products for Hepatitis C and cancer has been received well by doctors.
said it is on track for regulatory filings for four biosimilar and generic insulin drugs in the US and Europe in 2016, which would help the firm to get an early mover advantage in an addressable $30 billion market.
“As part of our global biosimilars strategy, Biocon
is targeting emerging markets (EMs) in the near term and developed markets subsequently. EMs represent 12-15% of the global opportunity for many of the key biosimilars in our portfolio, she said. We aim to be present in the top 10-15 EMs, which account for over 90% of the overall EMs opportunity. In many of these top 15 Ems, we are either already partnered or in advanced stages of discussion with respect to our biosimilars"," said Shaw.