CHAPEL HILL, N.C.--(BUSINESS WIRE)--Feb. 4, 2015--
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company
committed to transforming medicine that transforms lives, today
announced the issuance of a patent by the United States Patent and
Trademark Office (USPTO) entitled “Method for Treating a Patient at Risk
for Developing an NSAID-associated Ulcer” that relates to VIMOVO®
(naproxen/esomeprazole magnesium) delayed release tablets in patients
taking low dose aspirin. The patent expires in October 2031.
“This newly issued patent provides additional claims to the VIMOVO
patent estate,” stated John R. Plachetka, Chairman, President and Chief
Executive Officer. “This patent further demonstrates the continued
pattern of innovation by POZEN, which has resulted in 17 issued U.S.
Patents and many related foreign patents.”
The USPTO issued U.S. patent number 8,945,621 on February 3, 2015.
Horizon Pharma plc (NASDAQ: HZNP), which holds the U.S. NDA for VIMOVO,
and POZEN plan to list the U.S. patent in the U.S. Food and Drug
Administration's Approved Drug Products with Therapeutic Equivalence
Evaluations, or Orange Book. This will be the eleventh U.S. patent to be
listed in the Orange Book for VIMOVO.
VIMOVO (naproxen/esomeprazole magnesium) is a fixed-dose combination of
delayed-release enteric-coated naproxen, a non-steroidal
anti-inflammatory drug (NSAID), and immediate-release esomeprazole
magnesium, a stomach acid-reducing proton pump inhibitor (PPI), approved
for the relief of signs and symptoms of osteoarthritis, rheumatoid
arthritis and ankylosing spondylitis and to decrease the risk of
developing gastric ulcers in patients at risk of developing
NSAID-associated gastric ulcers. VIMOVO is not recommended for use in
children younger than 18 years of age. VIMOVO is not recommended for
initial treatment of acute pain because the absorption of naproxen is
delayed compared to absorption from other naproxen-containing products.
Controlled studies do not extend beyond six months. VIMOVO should be
used at the lowest dose and for the shortest amount of time as directed
by your health care provider.
For Full Prescribing Information see www.VIMOVO.com.
About POZEN Inc.
POZEN Inc. is a small pharmaceutical company that specializes in
developing novel therapeutics for unmet medical needs and licensing
those products to other pharmaceutical companies for commercialization.
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. Funded by these milestones/royalty streams,
POZEN has created 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
opportunities 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.
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, our ability to return
value to our stockholders, including any cash distributions, and our
future prospects 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 further license our YOSPRALA 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 due to issues with third-party manufacturers, or
the failure to obtain such approval of our product candidates for all
expected indications, 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 and Horizon for the sales and marketing of VIMOVO®, our
dependence on Patheon for the manufacture of YOSPRALA 81/40 and YOSPRALA
325/40; 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 September 30, 2014. We do not intend to update any of these
factors or to publicly announce the results of any revisions to these
Source: POZEN Inc.
Bill Hodges, 919-913-1030
Stephanie Bonestell, 919-913-1030
Investor Relations & Public Relations