Idenix, Novartis amend terms for license of Idenix hepatitis C drug

By Ted A. Knutson

Washington, March 2 - Idenix Pharmaceuticals, Inc. said Thursday it and its wholly owned subsidiary Idenix (Cayman) Ltd., and Novartis Pharma AG amended Novartis's option to license NM283, or valopicitabine, Idenix's lead product candidate for hepatitis C.

The amendment shortens the option exercise period to 30 days, and the period for starting the 30-day period was changed to a date relating to the delivery to Novartis by Idenix of certain data from the ongoing phase 2b clinical trials of valopicitabine.

If Novartis elects to exercise the option, it must deliver notice of its intent to do so, together with payment of a license fee, prior to the expiration of the 30-day notice period.

The option exercise period began on Feb. 27 and will lapse, if not exercised by Novartis, on March 29.

If Novartis exercises the option to collaborate with Idenix on valopicitabine, it will be required to provide development funding up to $525 million in license fees and other payments based upon achievement of regulatory milestones, as updated in the amendment, as well as additional milestone payments based upon achievement of predetermined sales levels.

Additionally, the responsibilities for phase 3 clinical development of the drug were further defined in the amendment and will be shared between Idenix and Novartis.

Idenix will have principal responsibility for the conduct of the phase 3 program evaluating valopicitabine in hepatitis C patients that have been previously treated with the current standard of care, ribavirin and interferon, and failed to adequately respond. Novartis will have principal responsibility for the conduct of the phase 3 program evaluating valopicitabine in patients not previously treated for chronic hepatitis C.

Idenix is a Cambridge, Mass.-based biotechnology company.

Novartis is a Basel, Switzerland-based drug company.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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