)
Glenmark Pharmaceuticals, the Mumbai-based pharmaceutical major with a large research and development pipeline, is set to out-license its molecule for pain management.
The molecule, GRC 17536, is expected to have a market potential worth $1 billion. According to people in the know, Glenmark is in talks with a few multinational giants and a deal is likely in a couple of months.
The molecule has successfully completed phase-II trials on 138 patients in Europe and India.
Under the out-licensing deal, Glenmark's partner will take the molecule through the remaining processes of drug development. Glenmark will get milestone payments after successful completion of each phase. It will also get royalties, as well as marketing rights for certain countries, once the drug hits the market.
During the past 10 years, Glenmark has signed seven out-licensing deals and made revenues worth $206 million as upfront payments. In 2011, it had out-licensed its GBR 500 molecule to Sanofi in a $613-million deal. However, media reports say the molecule, meant to treat Crohn's Disease and other inflammatory conditions such as multiple sclerosis, failed in further studies, which led Sanofi to terminate further trials. Glenmark had received an upfront payment of $25 million from Sanofi for this deal.
When contacted, a Glenmark spokesperson said the company would not comment on market speculation.
As part of cutting down costs, multinationals prefer to in-license molecules that have completed phase-I and -II clinical trials on humans successfully. The drug development process costs $1-3 billion.
In 2010, Oglemilast, a molecule for chronic obstructive pulmonary disease and asthma, out-licensed to Eli Lilly, failed to complete successful trials and the latter gave its rights over the molecule back to Glenmark. In 2008, Glenmark had faced a similar setback as Eli Lilly suspended trials of the GRC 2011 molecule after it failed to generate positive results.
In an interview with Business Standard last year, Glenmark chairman Glenn Saldanha had said: "The next financial year is important for us, as we will be getting crucial data points for some of our molecules in the pipeline. Some of these results, if positive, are expected to trigger out-licensing activities over the next 12 months."
Drug discovery is fraught with risks and failures are a given. But the important thing is it is addressing the critical area of globally unmet medical needs, he had told Business Standard.
