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POZEN Inc. (NASDAQ:POZN),
a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the third quarter ended September 30, 2013.
Recent Corporate Highlights
In September, POZEN and Sanofi US announced the signing of an exclusive license agreement for the commercialization of PA8140/PA32540. Under the terms of the agreement, Sanofi US will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN received an upfront payment of $15 million and will be eligible for pre-commercial milestone payments of up to $20 million and other future milestone payments and royalties on product sales. The upfront payment will be amortized over fifteen months starting in September 2013.Sanofi US will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S. POZEN will retain responsibility for obtaining approval of the New Drug Application (NDA), after which time POZEN will transfer the NDA to Sanofi US. The NDA was submitted in March 2013 and accepted for filing in May 2013 by the U.S. Food and Drug Administration (FDA) and has a user fee action date of January 24, 2014.
As part of POZEN’s ongoing interactions and requests for information from the FDA during its review of the NDA for PA8140/PA32540, the FDA has requested a teleconference, which has been scheduled for mid-November. POZEN will discuss and address the FDA’s request for information with respect to the existing clinical pharmacology data on PA8140.
POZEN is focusing its efforts on obtaining FDA approval of PA8140/PA32540, transitioning all know-how to Sanofi US, completing the remaining Phase 1 study and MAA filing for PA10040, evaluating the possibility of a MAA filing using existing data for the use of PA in secondary cancer prevention, attempting to partner all un-partnered assets, and reducing staff and expenses as warranted by business conditions. In addition, POZEN’s management team and board of directors are evaluating possible ways of returning value to shareholders, including cash distributions of surplus corporate cash.
Liz Cermak, Executive Vice President and Chief Commercial Officer, has announced her retirement from POZEN. Ms. Cermak led many facets of our PA program including POZEN’s efforts to secure the best agreement possible for shareholders with Sanofi US. POZEN will complete its commercial obligations to Sanofi US before the end of the fourth quarter, thus allowing Ms. Cermak the opportunity to retire at the end of the year.
In August, results of a POZEN-funded, community based study, demonstrating that concomitant proton pump inhibitor (PPI) therapy improves adherence in low-dose aspirin (ASA) users, was presented at the European Society of Cardiology Congress 2013 in Amsterdam.
POZEN and AstraZeneca AB executed two agreements in September relating to VIMOVO ® (naproxen / esomeprazole magnesium). An amendment to parties’ 2006 license and collaboration agreement clarified the intellectual property provisions of the agreement to expressly exclude products that contain aspirin. The other agreement provided, among other things, that in the event that AstraZeneca divests its rights to commercialize VIMOVO in the US, AstraZeneca will be relieved of its obligation to guarantee the performance of the acquiring party.
Q3 2013 global net sales of VIMOVO by AstraZeneca, as defined under our agreement, were $23 million, up 72% vs. Q3 2012 and down 1% from Q2 2013. POZEN earned a royalty of $1.6 million in Q3 2013.
Third Quarter Results
For the third quarter of 2013, POZEN reported revenue of $2.6 million compared to total revenue of $0.9 million for the third quarter of 2012. Revenue for 2013 was comprised of the royalty for sales of VIMOVO of $1.6 million and amortization of the upfront payment for PA8140/PA32540 of $1.0 million. Revenue for 2012 came entirely from the royalty for the sales of VIMOVO.