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POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicines that transform lives, today announced that the United States Court of Appeals for the Federal Circuit has affirmed the August 5, 2011 decision of the United States District Court for the Eastern District of Texas that had issued a favorable verdict in the litigation between POZEN and several generic pharmaceutical companies which had filed Abbreviated New Drug Applications (ANDAs) seeking approval from the U.S. Food and Drug Administration (FDA) to market generic copies of
Treximet® (sumatriptan / naproxen sodium).
Treximet is marketed by POZEN's exclusive U.S. licensee, GlaxoSmithKline (GSK). The Federal Court of Appeals affirmed the lower court ruling which held that U.S. Patent Nos. 6,060,499 (the ʼ499 patent) and 6,586,458 (the ʼ458 patent) were valid, enforceable and infringed by Par Pharmaceutical, Inc. (Par), Alphapharm Pty Ltd. (Alphapharm), and Dr. Reddy’s Laboratories, Inc. (DRL). A third patent, U.S. Patent No. 7,332,183 (the ʼ183 patent) covering the
Treximet formulation was valid, enforceable and infringed by Par and DRL. The ʼ183 patent was not asserted against Alphapharm.
POZEN was represented throughout the litigation by Vinson & Elkins L.L.P., including intellectual property partners Bill Schuurman and Steve Hash.
“We are pleased that the Court of Appeals has upheld the Eastern District of Texas’ ruling in favor of POZEN, thus upholding the patents protecting
Treximet,” said John R. Plachetka, Pharm.D., Chairman, President and Chief Executive Officer of POZEN Inc.
In November 2011, POZEN sold most of the future royalty and milestone payments under its collaboration and license agreement with Glaxo Group Limited, part of the GlaxoSmithKline group of companies (GSK), covering
Treximet sales in the United States to a financial investor for $75 million. By virtue of the agreement, the financial investor will be entitled to receive royalties on net sales of
Treximet and any other products containing sumatriptan and naproxen sodium developed and sold by GSK under the collaboration and license agreement in the United States on or after October 1, 2011. POZEN retains rights to 20% of royalties paid on net sales of
Treximet and such other products in the United States, beginning in the second quarter of 2018.
POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestone/royalty streams, POZEN is now creating a portfolio of cost-effective, evidence based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.