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Nuvo Research Announces Successful Completion Of All Pennsaid(R) Studies
Date:1/28/2009

-Expects to File Pennsaid FDA Resubmission Within 60 Days-

MISSISSAUGA, ON, Jan. 28 /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, today announced that it has successfully completed all of the studies that will support the Company's resubmission of its Pennsaid application to the United States Food and Drug Administration (FDA). Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is currently marketed in Canada and several European countries to treat the pain and symptoms associated with osteoarthritis.

"We are confident that the results and information gathered from these studies will provide the FDA with the data it requires to give Nuvo final, unconditional approval to market Pennsaid in the U.S." said Dr. Henrich Guntermann, President and CEO of Nuvo.

Nuvo is in the process of finalizing its resubmission for Pennsaid approval, which it expects to file with the FDA within the next 60 days. Upon acceptance of the filing, the FDA is expected to provide Nuvo with a date under the Prescription Drug User Fee Act (the PDUFA date), by which the FDA will advise Nuvo of its decision respecting Pennsaid's approvability. Nuvo anticipates the PDUFA date will be six months after it files its Pennsaid resubmission.

Nuvo's resubmission is a complete response amendment to an approvable letter for Pennsaid received from the FDA in December of 2006. In that letter, the FDA confirmed that Pennsaid could be approved for sale in the U.S. once certain conditions were satisfied. None of the conditions relate to clinical efficacy or clinical safety of Pennsaid, which were evidenced in Nuvo's Phase 3 clinical trials, and the FDA has not requested that Nuvo conduct any additional clinical efficacy or safety trials.

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SOURCE Nuvo Research Inc.
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