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Vitaros

Generic name: alprostadil
Treatment for: Erectile Dysfunction

NexMed Discusses End of Review Meeting for Vitaros

NexMed Discusses End of Review Meeting for Vitaros

EAST WINDSOR, N.J.--(BUSINESS WIRE)--Oct 20, 2008 - NexMed, Inc., a developer of innovative treatments based on the NexACT technology, announced today that it met with the Food and Drug Administration (FDA) on October 15, 2008 concerning Vitaros, its topical treatment for erectile dysfunction. The purpose of the meeting was to gain clarification on the major deficiencies cited by the FDA in their July 21, 2008 action letter (the "Action Letter") and to reach consensus on the necessary actions for addressing these deficiencies for its Vitaros New Drug Application (NDA).

A summary of the key regulatory concerns and agreements by the participants is as follows:

  1. Overall Carcinogenicity Assessment: The Division has agreed to NexMed's request for a review of this assessment by the Carcinogenicity Advisory Committee (CAC) prior to NexMed's Class 2 resubmission in reply to the Action Letter. The CAC will review NexMed's briefing package, which includes the results from its three, two-year carcinogenicity studies in mice and rats, and determine whether the new weight of evidence can alleviate the FDA's concerns over the positive results from the TgAC (transgenic mouse) study. NexMed plans to submit this briefing package for CAC review by the end of the year.
  2. Assessment of the transfer to the partner of NexMed's NexACT technology: The Division concurs with NexMed's proposal to conduct one Phase 1 study in healthy volunteers, with the design of the trial to be determined.
  3. Assessment of transmission of sexually transmitted diseases (STDs): The Division concurs with NexMed's proposal to conduct one animal study, with the animal model to be determined.
  4. GMP (Good Manufacturing Practices) Status of NexMed's manufacturing facility: NexMed has adequately addressed the deficiencies cited in FDA's Pre-Approval Inspection and the FDA has revised the status from "withhold" to "acceptable."

Vivian Liu, NexMed's Chief Executive Officer commented, "We had a very productive meeting with representatives of the FDA. We now have a well-defined roadmap as to the actions necessary for addressing the deficiencies for our Vitaros NDA prior to our Class 2 resubmission."

Hem Pandya, NexMed's Chief Operating Officer, commented, "We remain positive about the viability and approvability of our product. We know from the feedback we have received that there is real demand for Vitaros from both patients and the urology community at large. Once we obtain feedback from the CAC and additional input from the FDA regarding any remaining outstanding issues, we will be better able to provide guidance on the estimated timeline for our Class 2 resubmission in reply to the Action Letter. Once the Class 2 resubmission has been made, the FDA will then start the six month review clock."

NexMed Management will provide an update on the Vitaros action items during its third quarter conference call on November 11, 2008, details of which will be issued closer to the date of the call.

About NexMed

NexMed, Inc. is leveraging its proprietary NexACT drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. 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, raising sufficient financing to continue its operations, entering into partnering agreements, pursuing growth opportunities, and/or other factors, some of which are outside the control of the Company.

Contact

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

Posted: October 2008

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