CHAPEL HILL, N.C.--(BUSINESS WIRE)--June 1, 2004--POZEN Inc.
(Nasdaq:POZN) today announced that the U.S. Food and Drug
Administration (FDA) issued a not-approvable letter on Friday, May 28,
2004 concerning the New Drug Application (NDA) for MT 100(TM) for the
acute treatment of migraine. MT 100 is a novel combination of naproxen
sodium and metoclopramide in a single tablet.
"Based on our understanding of our many previous communications
with the FDA and the data contained in the NDA, we are extremely
surprised and very disappointed by the Agency's action. We believe we
have provided the necessary data to support approval of MT 100 and
have requested a meeting with the FDA as soon as possible," said John
R. Plachetka, Pharm.D., chairman, president, and chief executive
officer of POZEN.
In the letter, the Agency noted that POZEN demonstrated
unambiguous statistically significant superiority of MT 100 compared
to an appropriate control on a valid measure of pain as well as on the
three associated symptoms of nausea, photophobia, and phonophobia in
one study. However, they noted that MT 100 did not clearly meet these
criteria in a second study.
The FDA also cited the apparent lack of superiority of MT 100 over
naproxen for sustained pain relief, which was the primary endpoint for
the two component studies. This appears to arise primarily from an
apparent difference in understanding between POZEN and the Agency as
to the appropriate statistical analysis of this endpoint.
Additionally, for the first time the Agency raised an
approvability issue concerning the risk of tardive dyskinesia (TD)
presented by the use of metoclopramide, one of the components of MT
100. In this regard, the Agency stated in their letter, "given the
number of patients exposed to MT 100 for at least one year in your
database (about 300), the absence of any detected cases is consistent
with a true rate of TD of about 1%, an unacceptably high risk in the
absence of any demonstrated advantage of the product." Further, the
Agency mentioned that based on animal studies, there may be a
potential risk of carcinogenicity, presumably due to metoclopramide.
It is unclear to the Company, however, what role this played in the
POZEN will be reviewing its options and will determine the best
way forward to continue to seek approval for this product.
POZEN to Host a Webcast Today at 9:00 a.m. Eastern Time.
POZEN will host a webcast today, June 1, at 9:00 a.m. Eastern time
to discuss the information in this release. The webcast will be live
and archived on POZEN's home page at 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 could differ
materially from those contained in the forward-looking statements,
which are based on 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, or the
failure to obtain such approval 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; 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 Form 10-Q for the
quarter ended March 31, 2004 under "Management's Discussion and
Analysis of Financial Condition and Results of Operations." We do not
intend to update any of these factors or to publicly announce the
results of any revisions to these forward-looking statements.
CONTACT: POZEN Inc.
John Barnhardt, VP of Finance and Administration,
Lisa Barthelemy, Director IR, 919-913-1044
Burns McClellan for POZEN
Kathy Jones, Ph.D., 212-213-0006 x39 (media)
SOURCE: POZEN Inc.