NexMed Provides Update on Canadian Filing for Vitaros®
10 Junio 2010 - 12:30PM
Business Wire
NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of
products based on the NexACT® technology, today provided an update
on the status of its New Drug Submission (“NDS”) with Health Canada
for Vitaros®, the Company’s topical treatment for erectile
dysfunction.
NexMed management has been advised that Health Canada is
continuing to review its response for acceptance, and the Company
expects to hear from the agency within the next 30 days. An
acceptance of the response by Health Canada will trigger a new,
150-day review cycle by the NDS reviewers for a final approval or
rejection of the marketing application.
On April 23, 2010, NexMed reported that it had received delivery
confirmation of its response to the CMC (Chemistry, Manufacturing
and Controls) concerns previously raised by Health Canada (the
"Response") related to its New Drug Submission for Vitaros, which
was filed in February 2008. The delivery confirmation provided
Health Canada with a 45-day screening for acceptance process of the
Response by their Regulatory Project Management group, or until
approximately June 4, 2010.
Management of NexMed also stated today that the Company is not
currently selling shares of its common stock pursuant to the
agreement with Brinson Patrick Securities Corporation. Further
information concerning the agreement with Brinson is available
pursuant to the Company’s Form 10Q filed on May 13, 2010.
About NexMed, Inc.
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. For
example, and without limitation, there can be no assurance that
Health Canada will accept the Company’s response for review or
approve Vitaros for sale in Canada.
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