-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.
The conditions in the approvable letter relate to the proposed Pennsaid bottle, the potential interaction of Pennsaid with other topical products and the requirement that Nuvo conduct pre-clinical studies to support the dermal safety of Pennsaid.
Nuvo believes that the completed studies, announced today, support the safety of the Pennsaid bottle, and provide the specific information identified by the FDA as needed to support the safe use of Pennsaid with other topical products. In addition, and as requested by the FDA, Nuvo has completed two pre-clinical repeat dose dermal toxicology studies in animals (the "Dermal Tox Studies"), both of which support Pennsaid's safety.
The FDA previously confirmed in written meeting minutes that a two-year dermal carcinogenicity study in animals (the "Dermal Carcinogenicity Study") could be completed and submitted to the FDA post approval provided that the Dermal Tox Studies did not show signals of safety concern. Nuvo believes that there are no such signals in the Dermal Tox Studies and intends to complete and submit the Dermal Carcinogenicity Study post approval as per its agreement with the FDA.
Pennsaid is a topical non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis. Pennsaid allows the active ingredient, diclofenac, to be delivered to a specific site via the surface of the skin and thus limits complications associated with systemic delivery. According to published clinical trials, Pennsaid is as effective as the maximum daily dose of comparable oral medication at relieving pain and stiffness associated with osteoarthritis of the knee, as well as improving overall well-being. There are more than 27 million Americans suffering from osteoarthritis, a very painful and debilitating condition, and the United States market for this condition is estimated at US$4 billion annually.
About Nuvo Research Inc.
Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Nuvo's lead product is Pennsaid, a topical non-steroidal anti-inflammatory used for the treatment of osteoarthritis. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications.
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Quebec and Wanzleben, Germany and a research and development Center in San Diego California. For more information, please visit www.nuvoresearch.com.
These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Companies consider the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding the future events, many of which are beyond the control of the Companies and their subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual reports, as well as in the Companies' Annual Information Forms for the year ended December 31, 2007. The Companies disclaim any intention or obligation to update or revise any forward-looking statements whether a result of new information, future events, or except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Companies' ongoing quarterly filings, annual reports and Annual Information Forms and other filings found on SEDAR at www.sedar.com.
|SOURCE Nuvo Research Inc.|
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