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BL Research Bureau

The signing of another agreement by Glenmark Pharmaceuticals, this time with global drug major Eli Lilly, for its clinical compound GRC 6211, marks a key breakthrough.

Firstly, it is one of the largest licensing agreements by an Indian firm in terms of milestone fees and secondly, this is further evidence of the potential of Glenmark’s discovery pipeline.

The current agreement that covers a molecule named GRC 6211 is currently in early clinical phase II development as a potential new treatment for pain relief.

The phase II is a crucial stage in clinical trials. Once the preliminary safety of the study drug has been established in phase I trials, phase II trials are performed on larger groups of human subjects and are used to assess how well the drug works. Phase II also marks a crucial stage in development when failure rates can be fairly high. However, the safety profile exhibited by GRC 6211 in phase I human trials was encouraging.

Under the terms of the latest agreement, Glenmark will receive an upfront fee of $45 million and could receive up to an additional $215 million in potential development and sales milestones for the initial version, as well as royalties on sales if GRC 6211 is successfully commercialised.

If other versions are successfully developed, Glenmark would be entitled to additional milestones of up to $90 million.

This takes the total possible payout at $350 million that should be seen in context with Glenmark’s consolidated revenues of $282 million in financial year 2007.

As the company aims to be an early launcher in this class and targets launching the molecule in 2011, the payment could be spread over the next four-five years. From the marketing standpoint, though Lilly will have marketing rights for North America, Europe and Japan — Glenmark will retain the marketing rights in all other countries and the right to co-promote GRC 6211 in the US.

The company is already targeting one-two new chemical entities to clinics every year.

In a short time, the company has built up a pipeline of 11 molecules; three of which are in clinical development and the other eight are at various stages of pre-clinical development and discovery.

The new molecules cover broad areas of inflammation, metabolic disorders and oncology.

Recently, Glenmark announced that in its other out licensing with deal Forest Laboratories Inc, its US partner got approval to conduct further clinical trials of an asthma drug.

Favourable partial response was given to the drug GRC 3886 for its application to conduct additional phase II trials in the US.

The total value of payments could be $190 million, it had said earlier.

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