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NEXMED RECEIVES
FDA RESPONSE FOR ED PRODUCT
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-Management Conference Call
on Wednesday, 7/23/08 at 8:30
a.m.-
East Windsor, NJ, July 22,
2008 -- NexMed, Inc. (Nasdaq:
NEXM), today announced the receipt
of a non approvable letter from
the U.S. Food and Drug Administration
(FDA) in response to its New
Drug Application (NDA) for its
topical treatment for erectile
dysfunction (ED). The major
regulatory issues raised by
the FDA were related to the
results of the transgenic mouse
carcinogenicity study which
NexMed completed in 2002.
Commenting on today's announcement,
Vivian Liu, President and Chief
Executive Officer of NexMed
said, "The transgenic mouse
concern raised by the FDA is
product specific, and does not
affect the dermatological products
in our pipeline. While we are
disappointed by the FDA's decision,
the deficiencies cited in their
letter were not unexpected.
One positive outcome is the
fact that the FDA did not cite
the lack of completion of our
long term open label safety
study as a deficiency. We are
encouraged that we do not need
to redo this study, which would
have taken up to 18 months to
complete and at a substantial
cost."
Hem Pandya, Vice President and
Chief Operating Officer of NexMed
added, "We remain committed
to bringing our ED product to
market, where there is a real
demand from both patients and
the urology community at large.
As such, we plan to meet with
the FDA and come to agreement
on the necessary actions required
in order to resubmit our NDA
and resolve the deficiencies
cited." Mr. Pandya further
added, "We will also submit
to the Agency final reports
for two new, two-year carcinogenicity
studies in both mice and rats,
which were identified in the
FDA's letter as part of the
information package needed to
resolve the major deficiencies
cited."
Conference Call
NexMed will host a conference
call to discuss the non-approvable
letter on Wednesday, July 23,
2008, at 8:30 am EST. The call
can be accessed in the U.S.
by dialing 877-407-9205 and
outside of the U.S. by dialing
201-689-8054 and asking the
conference operator for the
NexMed Conference Call. The
teleconference replay is available
for one week by dialing in the
U.S. 877-660-6853 and outside
of the U.S. by dialing 201-612-7415.
Replay pass codes 286 and 292154
are both required for playback.
The conference call will also
be Webcast live at URL http://www.investorcalendar.com/IC/CEPage.asp?ID=132337.
The Webcast replay will be available
for three months.
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About
NexMed, Inc.
NexMed, Inc. is leveraging its
proprietary NexACT drug delivery
technology to develop innovative
topical pharmaceutical products
that address unmet medical needs.
NM100060, a novel onychomycosis
treatment exclusively licensed
to Novartis, is currently in pivotal
Phase 3 trials in the U.S. and
Europe. In November 2007, NexMed's
New Drug Application for its alprostadil
treatment for erectile dysfunction
was accepted for review by the
FDA and the Company signed a U.S.
licensing agreement for the product
with Warner Chilcott. NexMed's
pipeline also includes a Phase
2 treatment for female sexual
arousal disorder and an early
stage treatment for psoriasis.
For further information about
NexMed, go to www.nexmed.com.
Statements under the Private
Securities Litigation Reform
Act: with the exception of the
historical information contained
in this release, the matters
described herein contain forward-looking
statements that involve risks
and uncertainties that may individually
or mutually impact the matters
herein described, including,
but not limited to, obtaining
regulatory approval for its
products under development,
entering into partnering agreements,
pursuing growth opportunities,
and/or other factors, some of
which are outside the control
of the Company. # # #
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