CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration (FDA) approval of VIMOVO™ (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application (IND) and New Drug Application (NDA) for VIMOVO to AstraZeneca over the next few weeks.
An additional $25 million milestone will be payable if VIMOVO receives marketing approval in a major ex-U.S. market (including pricing and reimbursement approval). Under the terms of the agreement, AstraZeneca will pay POZEN royalties on net sales of VIMOVO worldwide and POZEN could receive up to $260 million in sales performance milestones, if certain sales thresholds are achieved. AstraZeneca has responsibility for all commercialization activities.
VIMOVO is approved for the relief of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is a fixed-dose combination of enteric-coated naproxen, a pain–relieving non-steroidal anti-inflammatory drug (NSAID) and immediate-release esomeprazole, a proton pump inhibitor.
The FDA approval of VIMOVO marks the second time in just two years that POZEN has received an FDA approval for a new product, which required the demonstration of superiority over an active comparator in two large pivotal Phase 3 trials. This makes POZEN a standout among biotech and specialty pharmaceutical companies, one of only a very few that have ever earned FDA approval for a self-invented product, and one of an even smaller number of companies to do this twice.
About POZEN
POZEN Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company committed to transforming medicine that transforms lives. Since its founding in 1996, POZEN has successfully created novel pharmacologic agents primarily for pain and pain-related conditions by combining existing drug therapies that result in superior patient outcomes. Moving forward, POZEN is poised to become a model 21st Century pharmaceutical company dedicated to ensuring that they produce cost-effective, evidence-based medicines; take a fresh approach to sales, marketing and medical education; and deliver high-quality, affordable pharmaceuticals to their customers.
The Company’s common stock is traded on The NASDAQ Stock Market under the symbol “POZN”. For more detailed company information, including copies of this and other press releases, please visit: www.pozen.com.
Safety Information
VIMOVO™
Cardiovascular Risk - Naproxen, a component of VIMOVO, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk - NSAIDs, including naproxen, a component of VIMOVO, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.
VIMOVO is contraindicated in patients with known hypersensitivity to any component of VIMOVO or substituted benzimidazoles; in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; in patients during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery; or in patients in the late stages of pregnancy. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Treatment should be withdrawn when active and clinically significant bleeding from any source occurs. As with all NSAIDs, VIMOVO can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular (CV) events. Blood pressure should be monitored closely. Fluid retention and edema have been observed in some patients taking NSAIDs, including VIMOVO. NSAIDs should be used with caution in patients with fluid retention or heart failure. NSAIDs, including VIMOVO, may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors and angiotensin II antagonists, beta-blockers, and in some patients can reduce the natriuretic effect of furosemide and thiazides. VIMOVO can be administered with low-dose aspirin (less than or equal to 325 mg/day) therapy. The concurrent use of aspirin and VIMOVO may increase the risk of serious adverse events. VIMOVO is not recommended in patients with moderate or severe renal insufficiency. In addition, NSAIDs may cause renal toxicity. VIMOVO is not recommended in patients with severe hepatic insufficiency. Consider dose reduction in mild/moderate hepatic insufficiency. If abnormal liver enzymes persist or worsen discontinue use immediately. Serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal and can occur without warning. Discontinue VIMOVO at first appearance of skin rash or any other sign of hypersensitivity. Symptomatic response to esomeprazole, a component of VIMOVO, does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which VIMOVO contains an enantiomer. Several studies and literature reports indicate that long-term proton pump inhibitor (PPI) therapy is associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Esomeprazole, a component of VIMOVO, inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin). Concomitant use of VIMOVO and warfarin may result in increased risk of bleeding complications. Monitor for increases in INR and prothrombin time. The most commonly observed adverse events in clinical trials (experienced by >5% patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea.
For complete Safety and Prescribing Information, including Boxed Warnings, please visit www.vimovo.com.
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on GlaxoSmithKline for the sales and marketing of Treximet(R) and our dependence on AstraZeneca for the sales and marketing of VIMOVO™; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quaterly Report on Form 10-Q for the period ended March 31, 2010. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Contact:
POZEN Inc. Bill Hodges, Chief Financial Officer, 919-913-1030
