-Provides Nuvo with PDUFA date of August 5, 2009-
MISSISSAUGA, ON, Feb. 19 /CNW/ - 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 the U.S. Food and
Drug Administration (FDA) has accepted Nuvo's resubmission of its application
for FDA approval to market Pennsaid in the U.S. as a complete response to the
FDA's December 28, 2006 Approvable Letter. The FDA has indicated that it
intends to advise Nuvo of its decision regarding Pennsaid approvability by
August 5, 2009 (the "PDUFA Date") under the Prescription Drug User Fee Act.
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 now less than six months away from the anticipated approval of
Pennsaid in the U.S.," said Dr. Henrich Guntermann, President and CEO of Nuvo
Research. "We are extremely optimistic about Pennsaid's potential for approval
and are continuing discussions with potential U.S. licensing partners."
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 drug 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
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company
headquartered in Mississauga, Ontario, with manufacturing facilities in
Varennes, Québec and Wanzleben, Germany and a research and development Center
in San Diego, California. For more information, please visit
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 Company
considers 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 future events, many of which are beyond the control of
the Company, 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 report, as well as in the Company's Annual Information
Form for the year ended December 31, 2007. The Company disclaims any intention
or obligation to update or revise any forward-looking statements whether a
result of new information or future events, except as required by law. For
additional information on risks and uncertainties relating to these
forward-looking statements, investors should consult the Company's ongoing
quarterly filings, annual report and Annual Information Form and other filings
found on SEDAR at www.sedar.com.
For further information:
For further information: about Nuvo, please contact: Media and Investor
Relations, Adam Peeler, The Equicom Group Inc., Tel: (416) 815-0700 x225,