POZEN files motion for Treximet patent litigation against Par

Mar 23 2011

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicines that transform lives, today announced that it has filed a motion for a preliminary injunction seeking to prevent Par Pharmaceuticals, Inc. (Par) from launching a generic version of Treximet^® (sumatriptan and naproxen sodium). Par, which POZEN believes has 180 days of exclusivity for its generic product as the first company to file an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA), could launch the product into the United States market, at risk, after regulatory exclusivity for Treximet expires on April 15, 2011. The motion was filed in the United States District Court for the Eastern District of Texas, where the Company's ongoing patent litigation against Par and several other generic companies is pending. There can be no assurance that the motion will be granted.

The Company has three issued U.S. patents covering Treximet which are licensed exclusively to GlaxoSmithKline (GSK) in the United States, two of which expire in August 2017 and one which expires in October 2025, which have been challenged by four generic companies who have filed ANDAs with FDA seeking approval to market generic versions of the product. The Company filed suit against Par, Alphapharm Pty Ltd., ("Alphapharm"), Teva Pharmaceuticals USA ("Teva"), and Dr. Reddy's Laboratories, Inc. ("Dr. Reddy's"), all in the United States District Court for the Eastern District of Texas, and the cases were consolidated into one suit. A settlement was reached with Teva in April 2010. The case against Par, Alphapharm and Dr. Reddy's was tried before Judge Leonard Davis in October 2010. A decision in the case is pending.

POZEN continues to have full confidence in the strength of its intellectual property rights protecting Treximet and will continue to vigorously defend and enforce its intellectual property.