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Glenmark outlicences pain molecule to Eli Lilly; deal projected at $350 m

Our Bureau

Mumbai, Oct. 30

In what will be the third molecule from Glenmark Pharmaceuticals Ltd to get out-licensed, the company has entered into an agreement with Eli Lilly for its prospective pain molecule, GRC 6211. The deal has a projected potential of $350 million, and Glenmark has received an upfront payment of $45 million.

The deal is the largest for Glenmark that has in the past out-licensed its prospective asthma and diabetes molecules as well.

At a projected $350 million, the deal is the biggest in the Indian pharmaceutical industry, despite the later payments coming only on achieving certain parameters, industry-watchers observed.

Following the initial upfront payment, Glenmark could receive up to an additional $215 million in potential development and sales milestones for the initial indication, as well as royalties on sales if GRC 6211 is successfully developed, the company said.

On further development, it would be entitled to additional milestones up to $90 million.

"The deal shows we understand what it takes to discover a molecule and take it to Phase II," Mr Glenn Saldanha, Glenmark's Managing Director and Chief Executive Officer said.

The clinical trials on this molecule were done in Europe, he said, and the molecule is at present undergoing Phase II a trials, where the molecule is targeted on a larger sample size of people with the illness that the molecule is targeting.

Lilly will have marketing rights for North America, Europe and Japan, while Glenmark will retain the marketing rights in all other countries.

Further Glenmark will have the right to co-promote GRC 6211 in the US, a note from the company said, without disclosing other details.

Mr Saldanha also said that Lilly will have the rights and intellectual property to its portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, in the pain segment. GRC 6211 is the lead molecule in this programme, he explained. Glenmark shares were up over 4 per cent on Tuesday, at Rs 474.20 on the BSE.

COPD/Asthma molecule

On Monday Glenmark had said that the United States Food and Drug Administration had given a favourable partial response to its promising chronic obstructive pulmonary disorder (COPD) and asthma molecule Oglemilast (GRC 3886), allowing the company to go ahead with additional clinical trials on the molecule.

The partial regulatory approval came after a submission made by Forest Labs, addressing the FDA's non-clincial questions. Glenmark had entered into a $190-million agreement with Forest in September 2004.

Merck Deal

Glenmark also clarified on the impact of Merck's restructuring on Glenmark's prospective diabetes molecule GRC 8200. It formalised an outlicensing agreement with Merck KgaA on GRC 8200 in 2006. Merck paid an upfront payment of ?25 million to Glenmark on signing the ?190-million deal.

Glenmark said that it did not have to return the milestone payment and the development of the drug was on track. While the companies were in discussions, the two options before Glenmark are: the molecule could return to Glenmark, for re-licensing to another partner. Or Merck could help Glenmark scout for another partner, the company said.

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