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GlaxoSmithKline Collaboration
 

In April 2008, the successful collaboration between POZEN and GlaxoSmithKline (GSK) culminated in the approval of Treximet^® (sumatriptan and naproxen sodium) for the acute treatment of migraine attacks, with or without aura, in adults.  The partnership began in 2003, when GSK signed an agreement with POZEN Inc. for the development and commercialization of this combination product.  The deal terms included $80 million in upfront and certain development and regulatory milestone payments and an additional $80 million in sales performance milestones based on achievement of certain sales thresholds.

In May 2008, POZEN officially transferred the Investigational New Drug (IND) and New Drug Application (NDA) for the product to GSK.  GSK is responsible for the commercialization of Treximet in the U.S.  POZEN receives royalties based on net sales of Treximet from GSK at a rate of 18 percent.  Treximet is available in U.S. pharmacies.

POZEN retains ex-U.S. rights to develop and market other triptan and NSAID combinations.  POZEN is seeking global partners to commercialize.

AstraZeneca Collaboration

POZEN entered into a collaboration agreement with AstraZeneca on August 1, 2006 for the co-development and commercialization of VIMOVO™ (enteric-coated naproxen/ immediate release esomeprazole magnesium), an investigational product that combines enteric-coated naproxen (an NSAID) with immediate release esomeprazole, a proton pump inhibitor (PPI).  VIMOVO is under investigation for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing NSAID-associated gastric ulcers.

AstraZeneca will pay POZEN up to $345 million, in aggregate, for the achievement of development, regulatory, and sales milestones. POZEN received $70 million, which included upfront payment and recognition of successful proof of concept, $55 million will be paid upon achievement of certain development and regulatory milestones, and $260 million will be paid as sales performance milestones if certain aggregate sales thresholds are achieved.  In addition, POZEN will receive royalties on net sales.

On August 31, 2009, the US Food and Drug Administration (FDA) informed AstraZeneca and POZEN Inc. that it had accepted the New Drug Application (NDA) for VIMOVO, submitted on June 30, 2009.  AstraZeneca submitted a Marketing Authorization Application (MAA) to the European Union via the Decentralized Procedure for VIMOVO on October 16, 2009. 

PA Franchise

POZEN is moving forward with commercialization plans for the PA franchise within the U.S.  PA32540, a coordinated-delivery tablet combining an immediate release omeprazole 40 mg layer surrounding a pH-sensitive layer of aspirin 325 mg that is administered orally once a day, is under investigation for the secondary prevention of cardiovascular disease in patients at risk of developing aspirin-associated gastric ulcers.  Our key focus will be on the US market, but we intend to have a commercial strategy tailored for other markets, which may include strategic partnerships.