NUVO RECEIVES APPROVABLE LETTER FROM U.S. FDA FOR PENNSAID
-A POTENTIAL NEW OSTEOARTHRITIS TREATMENT FOR THE KNEE
nuvoresearch.com
Mississauga,
Ontario, Canada – December 29, 2006 - Nuvo Research Inc.
(TSX:NRI) today announced that it has received an approvable letter from the U.S.
Food and Drug Administration (FDA) for Pennsaid® (1.5% w/w diclofenac sodium
solution), a topical non-steroidal anti-inflammatory (NSAID) developed by Nuvo for
use as a treatment of osteoarthritis (OA) of the knee. Pennsaid is based on Nuvo’s
skin-penetrating technology that allows diclofenac to be delivered directly to the knee
via topical application to the surface of the skin thus minimizing systemic side effects
often associated with oral therapies.
In its letter, the FDA indicated that Pennsaid is approvable subject to Nuvo satisfying
certain conditions. The Company plans to meet with the FDA early in 2007 to discuss
the letter.
“This approvable letter is a great achievement for our Company and a step forward to
the commercialization of Pennsaid in the U.S.,” said Dr. Henrich Guntermann, Nuvo’s
President and CEO. ”We plan to work closely with the FDA to resolve these
outstanding matters required to obtain final approval and expect to provide further
information following our meeting with the FDA."
The Arthritis Foundation estimates that more than 21 million Americans suffer from
osteoarthritis. Pennsaid would be the first topical NSAID product approved in the
United States where the osteoarthritis pain relief market is estimated at $4 billion US.
Nuvo’s amended New Drug Application (NDA) for Pennsaid was re-submitted to the
FDA and accepted for review in July 2006. To meet the FDA’s clinical efficacy and
safety requirements as stated in an August 2002 non-approvable (NA) letter, Nuvo
conducted study 112, a 12-week Phase III, 5-arm, double-blind trial of 775 patients.
This trial enrolled patients in the U.S. and Canada with symptoms of primary
osteoarthritis of the knee. The trial met all of its primary endpoints, being pain,
physical function and patient overall health assessment. The trial also demonstrated
comparable efficacy of Pennsaid to oral diclofenac. In total, more than 2,500 patients
have been exposed to Pennsaid in clinical studies.
To address the long-term safety requirements as stated in the August 2002 NA letter,
Nuvo conducted study 112E, a long-term multi-centre, single-arm safety study of
Pennsaid applied by patients with symptoms of osteoarthritis of the knee. In total,
793 patients were treated, including 448 patients for at least six months and 116
patients for at least one year. The key observation was that long-term use did not
cause any new, unexpected adverse events.
About Pennsaid
Pennsaid is a topical non-steroidal anti-inflammatory (NSAID) used for the treatment
of osteoarthritis and is currently approved for sale in Canada and several European
countries. Pennsaid allows the diclofenac solution to be delivered to a specific site via
the surface of the skin and thus avoids 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.
About Nuvo Research Inc.
Nuvo is focused on developing innovative site-specific therapeutics that are delivered
topically using the Company’s skin-penetrating technologies. Nuvo’s lead product is
Pennsaid®, a topical non-steroidal anti-inflammatory (NSAID) used for the treatment
of osteoarthritis. Nuvo intends to leverage its skin-penetrating technologies to create
a portfolio of transdermal products targeting a variety of indications.
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company
headquartered in Mississauga, Ontario, with its research and development facility in
San Diego, California and manufacturing facilities in Varennes, Québec and
Wanzleben, Germany. For more information, please visit www.nuvoresearch.com.
This release may contain forward-looking statements, subject to risks and
uncertainties beyond management's control. Actual results could differ materially from
those expressed here. Risk factors are discussed in the Company's annual
information form filed with the securities commissions in each of the provinces of
Canada. The Company undertakes no obligation to revise forward-looking statements
in light of future events.
Contact:
Investors:
Christina Bessant
The Equicom Group Inc.
416-815-0700 x269
cbessant@equicomgroup.com
U.S. Media:
Timothy Bird
Cooney Waters Group
212-886-2210
tbird@cooneywaters.com |
