Vimovo Demonstrates Benefit Over Naproxen
Yesterday, at the American College of Gastroenterology meeting in San Diego, Pozen (POZN) released data from two phase III trials comparing Vimovo (formerly PN400) to enteric-coasted naproxen (ECN) in patients with osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) who are at risk of developing NSAID-associated gastric ulcers.
The data demonstrated that patients taking Vimovo experienced significantly greater reduction in severity of dyspepsia (SODA) and overall treatment evaluation for dyspepsia (OTE-DP) compared to patients taking ECN. The OTE-DP results showed 43-46% of the patients on Vimovo reporting positive change at month six vs. only 28-34% on ECN.
The results were highly statistically significant. Plus, patients taking Vimovo also had discontinuation rates far below ECN, at 3-5% vs. 11-12%, respectively. The safety of Vimovo was also superior to ECN, with only 2% of the patients experiencing erosive duodenitis as compared to 10-14% for ECN. Rates of erosive gastritis were also far lower in the Vimovo group at 18-21% vs. 38-39% for ECN.
Early in October, at the American College of Rheumatology meeting, Pozen presented data showing a significant reduction in the risk of gastric ulcers (GU), the primary endpoint of the phase III program, vs. ECN at a rate of 4-7% for Vimovo vs. 23-24% for ECN.
Vimovo is a fixed-dose combination of enteric-coated naproxen with an immediate release esomeprazole. Given the high risk for gastrointestinal side-effects for patients with OA and RA that take naproxen, roughly 60%, and the lingering concern on the cardiovascular safety of Cox-II inhibitors such as Celebrex post the withdrawal of Vioxx and Bextra, we believe that Vimovo has significant sales potential. Our financial model assumes Vimovo peaks at over $500 million worldwide. Pozen has partnered with AstraZeneca (AZN) for the commercialization of Vimovo.
Vimovo is currently under U.S. FDA review with an action date set for late April 2010. In mid-October, AstraZeneca filed for approval in the European Union via the decentralized procedure. Approval in the U.S. entitles Pozen to a $20 million milestone payment from AstraZeneca. The first approval outside the U.S. entitles Pozen to another $25 million.
The strong clinical data on Vimovo give us confidence in the phase III program for Pozen’s second pipeline candidate, PA-325/20, a fixed-dose combination of enteric-coated aspirin and immediate-release omeprazole. Similar to Vimovo, patients taking daily aspirin for cardiovascular protection or the potential reduction in the development of colorectal adenomas, are at risk for significant gastrointestinal side-effects. Phase II data on PA-325/20 demonstrated a significant reduction in gastric ulcers, 0% vs. 20%, after a 28-day concept study.
Third Quarter Performance
This morning, Pozen released financial results for the third quarter 2009. Total revenues for the quarter were $14.3 million, and consisted of $13.1 million in licensing and development revenues and $1.2 million in royalties on U.S. sales of Treximet at GlaxoSmithKline (GSK).
During the third quarter Pozen received a $10 million milestone for the filing of the U.S. NDA for Vimovo. The company earned $6.7 million, or $0.22 during the third quarter, 5 cents above our forecast. Pozen also has $51.3 million in cash and investments. We continue to be very positive on the stock and recommend purchase at this level — Pozen currently has a Zacks Recommendation of Outperform.
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