POZEN’S PA8140/PA32540 Receives a Complete Response Letter From FDA Citing Issues at a Facility of a Third Party Supplier o...
April 25 2014 - 8:30PM
Business Wire
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company
committed to transforming medicine that transforms lives, announced
today that their drug candidates PA8140/PA32540 (aspirin and
omeprazole) delayed release tablets have received a complete
response letter (CRL) from the U.S. Food and Drug Administration
(FDA). A CRL is issued by the FDA when the review of the file is
completed and questions remain that preclude the approval of the
new drug application (NDA) in its current form.
In the CRL, the FDA noted that, during an inspection of the
manufacturing facility of an active ingredient supplier that
concluded this week, inspection deficiencies were found.
Satisfactory resolution of deficiencies noted by the field
investigator is required before the NDA may be approved. POZEN
believes that these manufacturing facility items can be addressed
and will be working with the manufacturer to respond to the FDA as
soon as possible. There were no clinical or safety deficiencies
noted with respect to either PA8140 or PA32540 and no other
deficiencies were noted in the CRL. Final agreement on the draft
product labeling is also pending.
“Although we were hopeful for a first cycle approval, we believe
that the issues raised during the inspection can be remedied to the
satisfaction of the FDA. The timing of the inspection of this
facility was unfortunate as the final inspection report was only
issued today. Because it occurred so close to our PDUFA date, there
was no opportunity to address the issues raised,” said John R.
Plachetka, Chairman, President and Chief Executive Officer. “We
don’t want to speculate on the timing of the resubmission of the
NDA, or the timeline for eventual FDA action on that resubmission
until we have had a chance to talk again with all the concerned
parties, including the FDA. We will move as quickly as we can to
resolve any outstanding issues. We hope to be able to provide more
information about timing during our earnings call on May 8th.”
About PA
POZEN has created a portfolio of investigational integrated
aspirin therapies - the PA product platform. The products in the PA
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 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 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.
Proposed PA8140/PA32540 Indications and Usage (Pending FDA
Review and Approval)
PA8140/PA32540 Tablets contain 81 mg or 325 mg delayed release
aspirin and 40 mg immediate-release omeprazole and are indicated
for patients who require aspirin (1) to reduce the combined risk of
death and nonfatal stroke in patients who have had ischemic stroke
or transient ischemia of the brain due to fibrin platelet emboli,
(2) to reduce the combined risk of death and nonfatal MI in
patients with a previous MI or unstable angina pectoris, (3) to
reduce the combined risk of MI and sudden death in patients with
chronic stable angina pectoris, (4) in patients who have undergone
revascularization procedures (CABG, PTCA) when there is a
pre-existing condition for which aspirin is already indicated, and
to decrease the risk of developing gastric ulcers in patients at
risk for developing aspirin-associated gastric ulcers.
Controlled studies with PA8140/PA32540 Tablets do not extend
beyond 6 months.
About POZEN
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 in two
years. 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.
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, 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 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 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 Pharma for the sales and marketing of
VIMOVO®, our dependence on Sanofi US for the sales and marketing of
PA8140/PA32540 in the United States, if approved, and our
dependence on Patheon for the manufacture of PA8140/PA32540;
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, 2013. We do not
intend to update any of these factors or to publicly announce the
results of any revisions to these forward-looking statements.
POZEN Inc.Bill Hodges, 919-913-1030Chief Financial
OfficerorStephanie Bonestell, 919-913-1030Manager, Investor
Relations & Public Relations