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-Management
Conference Call at 5 pm EDT
Today-
East Windsor, NJ, August
26, 2008 -- NexMed, Inc.
(Nasdaq: NEXM), a developer
of products based on the NexACT®
drug delivery technology, today
announced that based on First
Interpretable Results of Phase
III clinical studies for NM100060,
a topical application of terbinafine
formulated with NexACT®
for the treatment of onychomycosis,
the decision has been taken
not to submit a New Drug Application
with the Food and Drug Administration
at this time.
The two NM100060 clinical studies
were randomized, double-blind
and placebo-controlled, and
designed to assess the efficacy,
safety and tolerability of NM100060
in patients with mild to moderate
toenail onychomycosis (nail
fungus). No significant adverse
event was reported in the studies.
NexMed entered into an exclusive,
worldwide agreement with Novartis
in September 2005, under which
Novartis assumed all clinical
development, regulatory, manufacturing
and commercialization responsibilities
for NM100060.
"While this is disappointing,"
said Vivian Liu, NexMed's President
and Chief Executive Officer,
"a European comparator
study is still ongoing, and
those results are expected mid
2009."
NexMed will host a conference
call to discuss today's announcement
this evening, August 26, 2008,
at 5 pm EDT. 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 295576 are both required
for playback. The conference
call will also be Webcast live
at URL http://www.investorcalendar.com/IC/CEPage.asp?ID=133535.
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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