NexMed Receives FDA Response for ED Product

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Tue Jul 22, 2008 4:38pm EDT

-Management Conference Call on Wednesday, 7/23/08 at 8:30 a.m.-
EAST WINDSOR, N.J.--(Business Wire)--
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.

   About NexMed

   NexMed, Inc. is leveraging its proprietary NexACT drug delivery
technology to develop innovative topical pharmaceutical products that
address unmet medical needs. Novartis is completing pivotal Phase 3
trials for NexMed's NM100060, a novel onychomycosis treatment
exclusively licensed to Novartis. In November 2007, the Company signed
a U.S. licensing agreement for the ED 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.

NexMed, Inc.
Mark Westgate, 609-371-8123, ext: 159
CFO
mwestgate@nexmed.com
or
Investor Relations:
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
pschwartz@rxir.com

Copyright Business Wire 2008
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