Mumbai, Oct 29 (UNI) City-based Glenmark Pharmaceuticals SA (GPSA), the wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd, today said the United States Food and Drug Administration (USFDA) has provided a favorable partial response to initiate an additional Phase II study in COPD for Oglemilast (GRC 3886), Glenmark's lead PDE4 inhibitor molecule.
Glenmark is working closely with Forest Labs, which is Glenmark's North American partner for Oglemilast, to detail out plans for further longer term development, while additional communication is expected from the FDA in the next two to three months.
Speaking on this development, CEO&MD, Glenmark Pharmaceuticals Ltd., Glenn Saldanha,said, ''The favourable response to Oglemilast from the FDA is an affirmation of Glenmark's research capabilities and our focussed approach towards drug discovery. We have a pipeline of 11 lead molecules at various stages of development, with an increasing focus on NBE research along with NCE research. This progress reiterates Glenmark's commitment towards setting benchmarks in speed, efficacy and monetisation of drug discovery&research.'' GRC 3886 is a novel, orally available PDE4 inhibitor in development for Chronic Obstructive Pulmonary Disorder [COPD], and may also have utility in other conditions such as Asthma. PDE4 inhibitors target the underlying cause of both COPD and Asthma by blocking inflammation through a non-steroid dependent mechanism.
Glenmark Pharmaceuticals is a research-led, fully integrated pharmaceutical company headquartered in Mumbai.