FDA Provides Preliminary Approval for Tradename ‘YOSPRALA’ Pending
Approval of the PA8140/PA32540 NDA
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Dec. 1, 2014--
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company
committed to transforming medicine that transforms lives, today
announced that it and Sanofi US have mutually agreed to terminate their
agreement for commercialization of the investigational products, PA8140
and PA32540 effective November 29, 2014. As of the effective date of the
termination, all licenses granted to Sanofi US will be terminated and
all rights to the products will revert to POZEN.
Additionally, the proposed tradename for these products, YOSPRALA, was
provisionally approved by the U.S. Food and Drug Administration (FDA)
pending final approval of the New Drug Application (NDA). In the future,
PA8140 will be referred to as YOSPRALA 81/40 (enteric-coated aspirin 81
mg/immediate release omeprazole 40 mg) and PA32540 (enteric-coated
aspirin 325 mg/immediate release omeprazole 40 mg) will be referred to
as YOSPRALA 325/40.
“Our goal at POZEN continues to be to maximize shareholder return.
Management and the Board of Directors are taking this opportunity to
evaluate all strategic options for YOSPRALA and POZEN,” said Dr. John
Plachetka, Chairman, President and Chief Executive Officer. “As we
continue to work with the FDA during these final weeks leading up to our
December 30th PDUFA date, we are very happy with the current
FDA-proposed package insert. With respect to how well YOSPRALA may
perform in the marketplace, we believe that the clinical profile of the
drug, as described in the current FDA-proposed package insert, will meet
or exceed the assumptions we made when we started our development and
evaluated the commercial potential for this product. Given that the
target population for YOSPRALA could exceed 20 million patients in the
US, we will be fully engaged in the near term evaluating strategic
options available to the company.”
Two (2) phase 3 clinical studies randomized 1,049 subjects to either
investigational YOSPRALA 325/40 (enteric-coated aspirin 325 mg/immediate
release omeprazole 40 mg) or EC aspirin 325 mg for 6 months of
treatment. Subjects taking YOSPRALA 325/40 reported 63 percent fewer
(p<0.001) gastric ulcers than those taking 325 mg enteric-coated
aspirin. In addition, patients taking YOSPRALA 325/40 reported 82% fewer
(p<0.001) discontinuations due to pre-specified upper gastrointestinal
(GI) adverse events than patients taking 325 mg enteric-coated aspirin.
Major adverse cardiac events (MACE) were similar between treatment
groups and occurred in 1.7% of subject on YOSPRALA 325/40 and 2.5% of
subjects on enteric-coated aspirin 325 mg. Seventy-two percent (72%) of
subjects on YOSPRALA 325/40 reported any adverse events compared to 85%
of subjects on EC aspirin 325 mg. The most commonly reported adverse
events with YOSPRALA 325/40 were gastritis, erosive gastritis,
dyspepsia, duodenitis, nausea, esophagitis, diarrhea, gastric polyps,
and non-cardiac chest pain.
POZEN will host a webcast Monday, December 1, 2014 at 8:30 a.m. (ET).
The webcast can be accessed live and will be available for replay at www.pozen.com.
About YOSPRALA (Formerly known as PA)
POZEN has created a portfolio of investigational integrated aspirin
therapies - the YOSPRALA product platform. The products in the YOSPRALA
portfolio are being developed with the goal of significantly reducing GI
ulcers and other GI complications compared to taking enteric-coated or
plain aspirin alone.
The first candidates are YOSPRALA 81/40, containing 81 mg of aspirin,
and YOSPRALA 325/40, containing 325 mg of aspirin. Both products are a
coordinated-delivery tablet combining immediate-release omeprazole (40
mg), a proton pump inhibitor, layered around a pH-sensitive coating of
an aspirin core. This novel, patented product is intended for oral
administration once a day and an indication is being sought for use for
the secondary prevention of cardiovascular disease in patients at risk
for aspirin-induced gastric ulcers.
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
Manager, Investor Relations & Public Relations