Glenmark Pharmaceuticals has got a favorable partial response from the US Food and Drug Administration (USFDA) to initiate an additional phase II study of its lead molecule for the treatment of asthma and chronic obstructive pulmonary disorder (COPD) - Oglemilast (GRC 3886), which Glenmark is developing with Forest laboratories of the US.
The approval came after Forest satisfactorily addressed FDA's outstanding non-clinical questions.
According to a release issued by Glenmark today, "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 2-3 months. Glenmark views this as an important positive step in continuing overall clinical development of Oglemilast."
Glenmark Pharmaceuticals SA (GPSA), the wholly-owned Swiss subsidiary of Glenmark, had entered into a collaborative agreement with Forest in September 2004 to further develop, register and commercialise GRC 3886 for the North American market. Forest paid Glenmark an up-front payment on initiation of the agreement, and will pay other milestones if the development and commercialisation of the product is successfully completed in the North American market. The total value of these payments could be $190 million. Additionally, after commercial launch, Glenmark will earn a royalty from Forest on net sales of the product, and, in addition, will supply all API to Forest.
"The favourable response to Oglemilast from the FDA is an affirmation of Glenmark's research capabilities and our focussed approach towards drug discovery. Today, 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," said Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticals. |
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