NDA Submission and Pre-Commercial Activities on Schedule
CHAPEL HILL, N.C., Oct 03, 2011 (BUSINESS WIRE) --
POZEN Inc. (NASDAQ: POZN),a pharmaceutical company
committed to transforming medicine that transforms lives, announces the
selection of Keelin Reeds LLC to assist in the strategic partner search
for PA32540, currently in late Phase 3 development. Keelin Reeds is a
global expert in helping life sciences companies value assets, develop
business development strategies and execute partnership transactions.
"With the NDA program on schedule for submission in the second half of
next year, and as we will be initiating our submission discussions with
regulators in other key territories, we believe it is time to launch the
search for the best commercial partner to maximize the sales potential
for PA32540," said John R. Plachetka, Chairman, President and Chief
Executive Officer of POZEN. "Keelin Reeds is the firm best suited to
help us find the ideal partner. We have added substantial value to this
asset by executing the critical NDA development and
pre-commercialization phases, and now it is our intention to secure a
relationship with one or more strategic partners in order to maximize
the sales potential of PA32540, both in the United States and globally."
"The ideal strategic partner for PA32540 is one who embraces our
philosophy of affordable pricing and shares our vision for the
therapeutic use and advantages of the brand," said Liz Cermak, Executive
Vice President and Chief Commercial Officer at POZEN. "In addition, the
right partner will have a strategic fit for the product, demonstrated
success selling in the cardiovascular field, and will allow POZEN to
participate as a true partner in the US while handling all commercial
activities elsewhere. By mid-2012, we will have completed all
foundational market research and branding, positioning and innovative
commercial strategy work for PA32540, and look forward to bringing these
critical assets to the partnership."
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 - something almost no other small pharmaceutical
company has done. Funded by these two 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.
The Company's common stock is traded on The NASDAQ Global Market under
the symbol "POZN". For more detailed company information, including
copies of this and other press releases, please visit www.pozen.com.
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 gastric ulcers compared to taking aspirin alone.
The most advanced product candidate is PA32540. It is a
coordinated-delivery tablet combining immediate release omeprazole, a
proton pump inhibitor (PPI), layered around an aspirin core with a
pH-sensitive coating. This patented product is administered orally once
a day and is being investigated for the secondary prevention of
cardiovascular disease in patients at risk for aspirin-induced gastric
ulcers.
Additionally, POZEN is conducting exploratory work on integrated aspirin
therapies for pain and pain-related conditions.
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
GlaxoSmithKline for the sales and marketing of Treximet(R)
and our dependence on AstraZeneca for the sales and marketing of
VIMOVO(TM); 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, 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
Chief Financial Officer
919-913-1030
or
Stephanie Bonestell
Manager, Investor Relations & Public Relations
919-913-1030
