NexMed Receives Screening Acceptance Letter from Health Canada for Vitaros®
June 23 2010 - 1:54PM
Business Wire
NexMed, Inc. (Nasdaq: NEXMD), a specialty CRO with a pipeline of
product candidates based on the NexACT® technology, today announced
that Health Canada has confirmed acceptance of the Company’s CMC
(Chemistry, Manufacturing and Controls) response for review. The
Screening Acceptance Letter (the “Acceptance Letter”) from Health
Canada was issued in connection with its New Drug Submission
(“NDS”) for Vitaros®, the Company’s topical treatment for erectile
dysfunction. The Acceptance Letter confirms that the CMC response
filed by NexMed is acceptable for the final, 150-day review cycle,
during which regulatory reviewers will determine the final
approvability of the product for marketing in Canada. Based on the
date of acceptance, a final approval decision is expected by the
end of November 2010.
Commenting on today’s news, Bassam Damaj, Ph.D., President and
Chief Executive Officer of NexMed, stated, “Receipt of the
Acceptance Letter marks another important milestone in the
development history of Vitaros and we remain positive about the
possibility for eventual product approval. As such, we anticipate
utilizing our Canadian application as the basis for filing new
marketing applications in other international markets.”
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 or any other foreign regulatory authority will
approve Vitaros for marketing approval.
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