New Drug Application Submission Anticipated in Q3 2012
Detailed Results to be Submitted for Journal Publication and
Presentation at a Future Scientific Meeting
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Mar. 22, 2012--
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company
committed to transforming medicine that transforms lives, announced
today positive top-line results from two pivotal Phase 3 clinical trials
of PA32540, a novel, coordinated-delivery tablet of immediate-release
omeprazole (40 mg) and delayed release aspirin (325 mg).
The two Phase 3 pivotal trials were randomized, double-blind,
multi-center studies in which a total of 1,049 subjects at risk for
developing aspirin-associated ulcers and already taking aspirin at a
dose of 325 mg once daily for at least three months for secondary
prevention of cardiovascular events were randomly assigned to treatment
with either PA32540 or 325 mg enteric-coated aspirin once daily. The
primary endpoint, a significant reduction in the cumulative incidence of
gastric ulcers following administration of PA32540 vs. 325 mg
enteric-coated aspirin over six months, was met in both studies.
Additionally, the studies met their key secondary endpoints, including a
reduction in gastroduodenal ulceration as well as a reduction in
discontinuation due to upper gastrointestinal adverse events in subjects
taking PA32540 compared to 325 mg enteric-coated aspirin. Reported
adverse events were consistent with the trial population and the known
adverse event profile of aspirin and omeprazole. Further analyses of the
data will be conducted, and presentation of the data at an appropriate
upcoming scientific meeting, as well as publication of the full results,
is planned.
“We are encouraged by the strength of the data and I commend the
clinical team here at POZEN and all our associates for their dedication
and hard work,” said John R. Plachetka, Pharm.D., the Company’s
Chairman, President and Chief Executive Officer. “This information is
essential to progress our PA32540 partnership discussions for the United
States, and to allow us to continue to move forward with our
preparations for a third quarter NDA submission for this product
candidate.”
About PA
POZEN is creating a portfolio of integrated aspirin therapies - the PA
product platform. The products in the PA portfolio are intended to
significantly reduce GI ulcers and other GI complications compared to
taking aspirin alone.
The first candidate is PA32540. It is a coordinated-delivery tablet
combining immediate-release omeprazole, a proton pump inhibitor, layered
around pH-sensitive aspirin. This novel, patented product is
administered orally once a day and will be indicated for use for the
secondary prevention of cardiovascular disease in patients at risk for
aspirin-induced ulcers. POZEN has completed the long-term safety study
and the two pivotal studies, targeting a New Drug Application submission
for 3Q12.
About POZEN
POZEN Inc. is a progressive pharmaceutical company that is transforming
how the healthcare industry addresses unmet medical needs. By utilizing
a unique in-source model and focusing on integrated therapies, POZEN has
successfully developed and obtained FDA approval of two self-invented
products in two years. Funded by these milestone/royalty streams, POZEN
is now creating a portfolio of cost-effective, evidence based integrated
aspirin therapies designed to enable the full power of aspirin by
reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the
opportunity for its portfolio assets.
The Company's common stock is traded under the symbol “POZN” on The
NASDAQ Global Market. For more detailed company information, including
copies of this and other press releases, please visit www.pozen.com.
Forward-Looking Statements
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 current market data and research (including third-party and
POZEN sponsored market studies and reports), 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
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 Annual Report on Form 10-K for the period ended December 31, 2011.
We do not intend to update any of these factors or to publicly
announce the results of any revisions to these forward-looking
statements.
Source: POZEN Inc.
POZEN Inc.
Bill Hodges, 919-913-1030
Chief
Financial Officer
or
Stephanie Bonestell,
919-913-1030
Manager, Investor Relations & Public Relations
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