Glenmark Pharmaceuticals has received a milestone payment of $15 million from US-based Forest Laboratories as part of the drug development agreement for its lead molecule Oglemilast (GRC 3886), ending the stalemate on progress of the drug for the past two years.
Under Glenmark's 2004 collaborative deal with Forest, the latter had the right to develop and sell the asthma and chronic obstructive pulmonary disorder drug in North America for an upfront payment and additional fees for each developmental milestone that could total $190 million in all.
Upon commercialisation, Glenmark will retain the rights for selling the drug for the rest of the world while Forest will continue to sell the drug in North American.
Glenmark has a similar collaboration agreement with Teijin Pharma for selling the drug in Japan. In October 2007, Forest received a favourable response from the US Food and Drug Administration, allowing it to initiate an additional phase II study in COPD for Oglemilast.
The approval came after Forest satisfactorily addressed FDA's outstanding non-clinical questions, which delayed the progress of phase II trials for many months.
A Glenmark spokesperson said the phase II advanced trials have already commenced in the US.
When the drug was licensed to Forest in 2004 in the Phase II stage, it was expected that the product could be commercialised by 2009. But the trials dragged on and there were apprehensions about the future of the drug among industry observers.
The news has come as a breather for Glenmark since last week Merck Serono, a division of global drug major Merck, had terminated its agreement with Glenmark Pharmaceuticals to develop its second drug under development, Melogliptin (GRC 8200), to treat type-two diabetes in the second phase.
Glenmark is currently scouting for a new partner to outlicense the drug.