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Glenmark signs $190-m pact with Forest Labs — To take asthma drug to N. America

Our Bureau

Mumbai , Sept. 23

GLENMARK Pharmaceuticals SA (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals India (GPL), has entered into a collaboration agreement with Forest Laboratories Inc, USA, for the development and commercialisation of PDE4 (phosphodiesterase 4) inhibitor GRC 3886 for chronic obstructive pulmonary disorder (COPD) and asthma.

As per the agreement, Forest will develop, register and commercialise GRC 3886 for the North American market. The deal is worth $190 million to the Indian company, provided the development and commercialisation of the product is successfully completed by 2009.

Glenmark retains commercialisation rights for the rest of the world as this deal covers only the $10-million North American market for COPD and asthma. The Indian company would also earn `mid-teens' royalty from Forest on net sales after the commercial launch and would supply active pharmaceutical ingredients (API) for sale by Forest.

The number of COPD patients in the US is put at 24 million and that of asthma at 20 million.

The GRC 3886 is an oral PDE4 inhibitor that is likely to have utility in other areas as well. The drug candidate is currently entering phase I clinical trials in the UK, conducted by Quintiles, and is expected to move into the second phase by March 2005. The estimated cost for running through the entire gamut of clinical trials for a new drug candidate is between $50 million and $75 million.

Talking to the media here, the Managing Director and CEO of GPL, Mr Glenn Saldanha, said this was easily the largest licensing deal concluded by an Indian company till date.

"While the development and commercialisation of the GRC 3886 in the US could come about by 2009, it could actually happen sooner in some of the other markets across the globe. We are formulating plans for the rest of the world. We may consider conducting the third phase clinical trials for the compound in India. This surely sheds light on what India can offer to the world in pharmaceuticals R&D," Mr Saldanha said.

The Chairman and CEO of the $2.65-billion Forest, Mr Howard Solomon, said, "We believe that Glenmark's PDE4 inhibitor may offer another important advance for the treatment of asthma and COPD with a recognised target and an excellent product profile in a therapeutic area in which we have had a great deal of experience. This marks our fourth product development collaboration announced this year."

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