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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, 2012.
POZEN is currently preparing the New Drug Application (NDA) for PA and is planning to seek approval for two dosage forms, PA32540 and PA8140. As previously disclosed, during a pre-submission meeting for the Company’s NDA for PA32540, the U.S. Food and Drug Administration (FDA) suggested that the Company also seek approval for a lower dose formulation of the product containing 81 mg of aspirin. POZEN continues to anticipate filing the NDA for both products in the first half of 2013.
POZEN presented positive results from two pivotal Phase 3 clinical trials of PA32540 at two scientific meetings.
Partnership discussions for PA continue to progress in the U.S., now that we believe we have resolution on requirements and timing for the NDA for PA32540 and PA8140. Given the timing of the NDA submission, we expect to close a deal in 2013.
As previously announced, the United States Court of Appeals for the Federal Circuit has affirmed the August 5, 2011 decision of the United States District Court for the Eastern District of Texas that had issued a favorable verdict in the litigation between POZEN and several generic pharmaceutical companies which had filed Abbreviated New Drug Applications (ANDAs) seeking approval from the FDA to market generic copies of Treximet® (sumatriptan / naproxen sodium). Treximet is marketed by POZEN's exclusive U.S. licensee, GlaxoSmithKline.
Q3 2012 global net sales of VIMOVO ® (naproxen / esomeprazole magnesium) delayed-release tablets, as defined under the agreement, were $13.4 million, up 38% from Q3 2011 but down 19% vs. Q2 2012. POZEN earned a royalty of $0.9 million for the quarter. As of the end of Q3 2012, VIMOVO has been filed for regulatory approval in 80 countries, approved in 60, and commercially launched in 40 countries.
Phase 3 Clinical Data Presented at Two Major Scientific Meetings
POZEN announced positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540. Each study achieved its individual primary endpoint, as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone. Data for the primary endpoint are shown below:
In addition, the results from the combined data from the two studies demonstrated that patients on PA32540, compared to those on enteric-coated aspirin (325 mg), were able to stay on therapy longer due to fewer discontinuations due to any adverse events (6.7% vs. 11.2%). A summary of discontinuation rates due to pre-specified upper gastrointestinal events is shown below:
Discontinuation Due To Pre-Specified UGI Events:
EC-ASA (325 mg)
Studies 301 & 302
In the combined data from the two trials, 85.1% of subjects on enteric-coated aspirin (325 mg) reported adverse events compared to 71.8% of subjects on PA32540. The most commonly reported adverse events with PA32540 and enteric-coated aspirin (325 mg) were of the GI tract and include dyspepsia (11.3% vs. 30.2%), erosive gastritis (11.5% vs. 26.3%), and gastritis (17.5% vs. 16.0%) respectively. The incidence and nature of adjudicated Major Adverse Cardiac Events (MACE), such as heart attacks, was similar between the two treatment arms: 9 subjects (1.7%) on PA32540 experienced adjudicated MACE compared to 13 subjects (2.5%) on aspirin (325 mg).