POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it has been notified by AstraZeneca that marketing and pricing approval for VIMOVO™ (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets, has been granted in the United Kingdom (UK). VIMOVO is indicated for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.
“To address the needs of millions of people worldwide who could benefit from aspirin therapy, POZEN is applying the proven science of integrated therapies to develop a family of products designed to enable the full power of aspirin by reducing its gastrointestinal toxicity.”
Under the terms of its agreement with AstraZeneca, POZEN will receive a $25 million milestone payment within 20 days. As a result of the payment, the Company is confirming its 2010 year-end guidance will be net income of $21 to $23 million. Additionally, the Company's year-end cash guidance is anticipated to be $63 to $65 million.
"We are looking forward to using this milestone to continue to fund and advance the development of our PA portfolio," said John Plachetka, Chairman, President and Chief Executive Officer of POZEN. "To address the needs of millions of people worldwide who could benefit from aspirin therapy, POZEN is applying the proven science of integrated therapies to develop a family of products designed to enable the full power of aspirin by reducing its gastrointestinal toxicity."
The products in the PA portfolio are intended to significantly reduce gastrointestinal (GI) ulcers and other GI complications compared to taking aspirin alone. According to the American Heart Association, 50 million Americans use aspirin regularly for cardiovascular disease prevention. Despite this, 20 percent of people on low-dose aspirin are at risk for serious GI complications; 25% discontinue or reduce their use of aspirin due to GI side effects; and low-dose aspirin discontinuation leads to three times increased risk of a potentially fatal cardiovascular event.