Nuvo expects to complete Pennsaid phase III by year-end
Nuvo Research Inc (TSX:NRI)
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Last Close 12/14/2005 $0.14
Thursday December 15 2005 - News Release
Ms. Lynn Riley reports
NUVO FORMS PANEL OF FDA EXPERTS IN ANTICIPATION OF PIVOTAL TRIAL RESULTS - COMPANY EXPANDS LICENSING DISCUSSIONS FOR PENNSAID(R) AND PENNSAID(R) PLUS
Nuvo Research Inc. anticipates completing its pivotal phase III trial for Pennsaid by year-end and disclosing preliminary results from the trial in January, 2006. In anticipation of filing an amended new drug application for Pennsaid with the United states Food and Drug Administration (FDA) in mid-2006, Nuvo has formed an FDA advisory panel to guide its FDA submission. Pennsaid, a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis, is approved for sale in Canada and several European countries.
"We expect to release preliminary efficacy results from our phase III clinical trial for Pennsaid in January, with long-term safety trial results to follow in February. These results will form the basis of our FDA submission," said Dr. Henrich Guntermann, Nuvo's president and chief executive officer. "Our advisory panel has extensive experience with FDA submissions and will prove invaluable as we prepare for this event. If approved by the FDA, we believe Pennsaid will be the first topical NSAID to market in the United States."
The company continues to pursue discussions with potential United States licensing partners for Pennsaid and its proprietary next generation product, Pennsaid Plus. Nuvo has contracted the services of California-based pharmaceutical consulting firm, Resources Development Inc. to identify suitable licensing partners and negotiate an appropriate licensing arrangement. Resources Development will supplement the previously announced consulting services of Canadian-based licensing consultant, Diane Kalina.
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