Glenmark Pharmaceuticals Ltd announced that a molecule under development in its labs has cleared the first phase of human clinical trials. Glenmark Pharmaceuticals S.A, a subsidiary of Glenmark, conducted the trials in the UK and said that the drug has been well tolerated with a good pharmacokinetic profile. Pharmacokinetics refers to how the body behaves when a drug enters the blood stream.
GRC 15300 is called a TRPV3 inhibitor, which is used to manage pain. TRPV3 stands for transient receptor potential cation channel, subfamily V, member 3. It is a new treatment approach to pain management and is indicated for treatment of neuropathic pain, osteoarthritis and other inflammatory pain, according to Glenmark’s website. The company says that GRC 15300 was the first molecule in its class to enter clinical trials.
Glenmark is a key generics player but is also pursuing an ambition of becoming an innovator in the global arena, and has several drugs under development.
Glenmark had out-licensed this molecule to Sanofi-Aventis in May 2010 with potential upfront payments of about $325 million or about Rs 1,450 crore at today’s exchange rates. This will be paid in stages, depending on development, regulatory and commercial milestones being achieved. Clearing Phase I trials would normally qualify as a development-related milestone.
The next two stages are critical and are ones where most research efforts by India pharmaceutical companies have faltered. There is a long path ahead for phase II and Phase III clinical trials to be conducted, and this is a resource-intensive exercise, both in terms of effort and money.
The opportunity is of course huge because this drug is a first in its class, under development. Glenmark has assessed the global market opportunity for neuropathic pain at $5 billion and for osteoarthritis at $4 billion. Under the tie-up, Sanofi will have exclusive rights for North America, Japan and European Union, with Glenmark having co-marketing rights in the US market. Sanofi and Glenmark will co-market the drug in 10 countries, including Brazil, China and Russia, while Glenmark will have exclusive rights for India and rest of the world.
While it is early days yet for an under-development drug, investors cheered at Glenmark’s research pipeline getting validation and the prospect of a one-time milestone-payment reflecting in the September quarter, the second quarter of the fiscal. Its share was up by about 3% at the time of posting. It is very difficult to predict how long Phase II and Phase III trials will take, and which way the trials will head. So far, none of the generic players have managed to bring a new drug to market in the lucrative and regulated markets of US or UK.
Read the press release from Glenmark on GRC 15300 clearing Phase I clinical trials here and the press release issued in May 2010 on the tie-up between Glenmark and Sanofi here.