Naproxen/esomeprazole combination was granted pan-EU clearance in October.
Pozen has earned a $25 million milestone payment from AstraZeneca, relating to U.K. marketing and pricing approval for Vimovo™ (naproxen/esomeprazole magnesium) 500/20 mg modified-release tablets.
Developed by Pozen and AstraZeneca, Vimovo is indicated for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers, and where treatment with lower doses of naproxen or other NSAIDs is not considered sufficient. The drug was granted approval throughout the EU in October. FDA approval for equivalent indications was granted in April.
Vimovo is the second of Pozen’s candidates to reach the market. In April 2008, FDA approved Treximet® (sumatriptan and naproxen sodium) for the acute treatment of migraine attacks, with or without aura, in adults. The product is formulated using Pozen’s technology for combining a triptan with an NSAID, and GlaxoSmithKline’s (GSK’s) RT Technology™. In May 2008, Pozen officially transferred the product to GSK, including the responsibility for commercializing Treximet in the U.S. Pozen receives royalties of 18% based on GSK’s net sales of the drug. Pozen also retains ex-U.S. rights to develop and market a lower dose sumatriptan and naproxen combination.
Pozen is developing its PA product pipeline, comprising a family of aspirin-based candidates designed to reduce the risk of gastrointestinal ulcers and other gastrointestinal complications associated with taking aspirin alone. Lead clinical-stage product, PA32540, is a sequential-release tablet combining immediate-release omeprazol, layered around pH-sensitive aspirin. The product is in development for the secondary prevention of cardiovascular disease in patients at risk of aspirin-induced ulcers. Phase III trials are ongoing. Pozen is also considering investigating PA32540 for the secondary prevention of colorectal neoplasias.