NexMed Files CMC Response with Health Canada for Vitaros®
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SAN DIEGO--(Business Wire)--
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based
on the NexACT® technology, announced today that it received delivery
confirmation of its response to the CMC (Chemistry, Manufacturing and Controls)
concerns raised by Health Canada (the "Response"). The Response is part of the
review process for its New Drug Submission ("NDS") for Vitaros®, the Company`s
topical treatment for erectile dysfunction treatment, which was filed in
February 2008. Health Canada has a 45-day screening for acceptance process of
the Response by their Regulatory Project Management group. The acceptance of the
Response triggers a new, 150-day review cycle by the NDS reviewers for a final
approval or rejection of the marketing application.
On January 19, 2010, NexMed announced that it had received a Notice of
Non-Compliance ("Notice") for its NDS pertaining to the review by the New Drugs
Quality Division of the Bureau of Pharmaceutical Sciences. The Notice is a
routine, end-of-review communication from Health Canada issued when additional
information is required to reach final decision on product approval.
Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, stated,
"NexMed met with Health Canada officials in February 2010 to discuss the
deficiencies cited in their Notice. At that time, we were given guidance and
reached agreement with the regulatory officials on the additional information to
be included in our Response, which we then submitted in a timely manner. We look
forward to receiving Health Canada`s decision and continue to be positive about
the possibility of eventual product approval."
About NexMed
NexMed is the largest specialty CRO based in San Diego, CA and is one of the
industry's most experienced CROs for in vitro and in vivo pharmacology services
and research models. The Company`s goal is to generate revenues from the growth
of its Discovery Pre-clinical CRO business, while aggressively seeking to
monetize its proprietary NexACT drug delivery technology through out-licensing
agreements with pharmaceutical and biotechnology companies, worldwide. At the
same time, NexMed is actively pursuing partnering opportunities for its
NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and
cancer. For further information on NexMed and its subsidiaries, visit the
following websites: http://www.nexmed.com or http://www.bio-quant.com.
Forward-Looking Statement Safe Harbor
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 for a variety of reasons that are outside the control of the Company
including but not limited to obtain regulatory approval for marketing Vitaros in
Canada.
NexMed:
NexMed, Inc.
Edward Cox, 858-926-5811
V.P. Investor Relations
ecox@nexmed.com
or
NexMed Investor Relations:
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
pschwartz@rxir.com
Copyright Business Wire 2010
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