CHAPEL HILL, N.C.--(BUSINESS WIRE)--
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to
transforming medicine that transforms lives, announced the presentation
of Phase 1 data, at the European Society of Cardiologists 2012 Congress,
from a study of PA32540, a novel coordinated-delivery tablet of
enteric-coated (EC) aspirin (325 mg) and immediate-release (IR)
omeprazole (40 mg). The data from the Co-Rx Study (pronounced “Co-Rex”)
suggest that PA32540 given in conjunction with clopidogrel, dosed at
least 10 hours apart, resulted in greater antiplatelet effects than
synchronously administered EC aspirin (81 mg), clopidogrel (75 mg), and
EC omeprazole (46.5% versus 39.9%, respectively, at day 7: 95%
confidence interval of the difference [2.57, 11.91]; p=0.004), in
healthy volunteers. These data were further presented at the European
Society of Cardiologists 2012 Congress in Munich, Germany on August 26,
2012.
“The results of the Co-Rx study provide important insights into the
interaction between omeprazole and clopidogrel," said Paul Gurbel, M.D.,
Director of the Sinai Center for Thrombosis Research at Sinai Hospital
of Baltimore, who is a lead investigator for the study and an
international authority on the pharmacodynamic effects of clopidogrel,
stated that, "Although the clinical significance of these results is
presently unknown, treatment with PA32540 may be a promising option for
the secondary prevention of heart attacks and strokes in cardiovascular
patients who require prolonged aspirin and clopidogrel therapy but are
at risk for gastric ulcers and bleeding.”
PA32540, an investigational coordinated-delivery tablet of
immediate-release omeprazole, a proton pump inhibitor (PPI), layered
around pH-sensitive aspirin, is being investigated for the secondary
prevention of cardiovascular disease in patients at risk for
aspirin-associated gastric ulcers. This investigational product is part
of POZEN's pipeline of integrated aspirin therapies, called the PA
product portfolio.
Separately, POZEN is pleased to announce the acceptance of abstracts
with regard to its clinical program for PA32540 at both the American
College of Gastroenterology (ACG) 2012 Annual Scientific Meeting, as
well as at The American Heart Association (AHA) 2012 Scientific Sessions.
Additionally, POZEN provided an update on its PA program and the results
of its Type A meeting with the FDA last week, wherein the Company
indicated that it is currently anticipating an NDA submission in the
first half of 2013.
About the Co-Rx Study
The Co-Rx study was a Phase 1, randomized, open-label, two-arm crossover
study in which 30 healthy subjects were treated with one of the
following: A) PA32540 in the morning plus Plavix®*
(clopidogrel) (300 mg) over 10 hours later on day 1, and PA32540 in the
morning plus clopidogrel (75 mg) 10 hours later on days two through
seven; B) enteric-coated aspirin (81 mg) plus clopidogrel (300 mg) plus
Prilosec®* (EC omeprazole) (40 mg) all in the morning on day
1 followed by enteric-coated aspirin (81 mg) plus clopidogrel (75 mg)
plus EC omeprazole (40 mg) all in the morning on days two through seven.
Subjects were first randomized to treatment A or treatment B and then
crossed over to the alternate treatment. Each treatment was separated by
a 14 day washout period.
The primary objective of the study was to assess the effects of PA32540
and EC omeprazole (40 mg) on clopidogrel activity as measured by ex-vivo
platelet aggregation using 20 uM adenosine diphosphate (ADP), a commonly
used platelet assay of clopidogrel effect.
The primary endpoint was the percent inhibition of platelet aggregation
(IPA) after morning dosing on day seven of each period. In the study,
PA32540 in the morning, plus clopidogrel 10 hours later, resulted in a
significantly greater IPA than enteric-coated aspirin (81 mg) plus EC
omeprazole (40 mg) plus clopidogrel all dosed in the morning.
* Plavix® is a registered trademark of Sanofi Aventis
Corporation; Prilosec® is a registered trademark of the
AstraZeneca AB group of companies.
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 candidates are PA32540, containing 325 mg of aspirin, and
PA8140, containing 81 mg of aspirin. Both products are a
coordinated-delivery tablet combining immediate-release omeprazole (40
mg), a proton pump inhibitor, layered around pH-sensitive aspirin. This
novel, patented product is administered orally once a day and an
indication will be sought for use for the secondary prevention of
cardiovascular disease in patients at risk for aspirin-induced ulcers.
About Antiplatelet Therapy
Aspirin has become the standard of care for the reduction of an
individual's risk of a second heart attack. Clinical studies have found
that a daily aspirin regimen for people who have experienced a previous
heart attack reduces the risk of a second heart attack by about
one-third. Clopidogrel and aspirin are currently co-prescribed in some
cardiovascular patients; however, the use of clopidogrel plus aspirin
increases the risk of gastrointestinal (GI) bleeding in certain
patients. These at-risk patients may benefit from the use of
gastro-protective agents such as proton pump inhibitors (PPIs),
including omeprazole. Recently, the U.S. Food and Drug Administration
(FDA) modified the clopidogrel and omeprazole labels to include warnings
against co-prescribing omeprazole and clopidogrel, based on ex-vivo
platelet aggregation studies.
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 inability to license our PA product
candidates on terms and timing acceptable to us, 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 Quarterly Report on Form 10-Q for the
period ended June 30, 2012. We do not intend to update any of these
factors or to publicly announce the results of any revisions to these
forward-looking statements.
