InvestorsHub Logo
Followers 466
Posts 26950
Boards Moderated 2
Alias Born 09/11/2006

Re: surf1944 post# 2166

Thursday, 11/08/2012 9:01:41 AM

Thursday, November 08, 2012 9:01:41 AM

Post# of 2237
7:36AM POZEN misses by $0.04, misses on revs; announces positive results for Phase 3 trial for PA32540, studies achieve primary endpoints (POZN) 5.41 : Reports Q3 (Sep) loss of $0.19 per share, $0.04 worse than the Capital IQ Consensus Estimate of ($0.15); revenues fell 81.6% year/year to $0.9 mln vs the $2.73 mln consensus.

Key Points:

POZEN is currently preparing the NDA for PA and is planning to seek approval for two dosage forms, PA32540 and PA8140.
Q3 2012 global net sales of VIMOVO delayed-release tablets, as defined under the agreement, were $13.4 million, up 38% from Q3 2011 but down 19% vs. Q2 2012.

Data for Phase III trial for PA32540

As previously disclosed, during a pre-submission meeting for the Company's NDA for PA32540, the 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 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.
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%).
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.