Nuvo Research Inc.
(TSX: NRI) today provided an update on discussions with the U.S. Food and
Drug Administration ("FDA") regarding the approvable letter issued by the
FDA on December 28, 2006 (the "Approvable Letter") for Pennsaid, a
non-steroidal anti-inflammatory drug (NSAID) used for the treatment of
osteoarthritis.
In a recent meeting with the FDA, the additional requirements for
approval as outlined in the Approvable Letter were discussed. The matters
raised in the Approvable Letter do not relate to clinical efficacy or
clinical safety of Pennsaid as evidenced in Nuvo's Phase III trials and the
FDA has not requested that Nuvo conduct any additional Phase III clinical
trials. In order to resolve certain matters raised in the Approvable
Letter, the Company may be required to generate additional data before
approval.
Nuvo is in ongoing communications with the FDA regarding the specifics
and timing of the additional information required and the Company will
provide further updates as the steps toward Pennsaid approval are
clarified.
None of the matters outlined in the Approvable Letter were raised by
the FDA in its Non-Approvable letter of August 2002 (the "Non-Approvable
Letter") to which Nuvo responded when it resubmitted its application for
Pennsaid approval in June of 2006.
Nuvo continues to be in discussions with potential partners for the
licensing of Pennsaid in the US.
"We are obviously disappointed that approval of Pennsaid may be
delayed," said Henrich Guntermann, President and CEO. "We will continue to
work with our advisors and the FDA to determine the appropriate path
forward to secure the approval of Pennsaid in the U.S."
To meet the FDA's clinical efficacy and clinical safety requirements as
outlined in the Non-Approvable 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 with respect to pain,
physical function and patient overall health assessment. The trial also
demonstrated comparable efficacy of Pennsaid to oral diclofenac. To address
the long-term safety requirements as outlined in the Non-Approvable Letter
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.
In total, more than 2,500 patients have been treated with Pennsaid in
clinical studies. Pennsaid has been approved in Canada and several European
countries and more than 1.5 million prescriptions for Pennsaid have been
written to date in those countries.
Early Warrant Incentive Program Update
The Company also announced the results of the warrant incentive program
("incentive program") which was designed to encourage the early exercise of
three series of common share purchase warrants by January 31, 2007. In
total, 19,548,455 warrants were exercised resulting in gross proceeds of
approximately $7.9 million. The proceeds will allow Nuvo to continue
executing its current business plan relating to the development and
commercialization of Nuvo's pharmaceutical products, primarily its
Pennsaid(R) and Pennsaid Plus(R) products.
All remaining warrants will continue to be exercisable for common
shares on the same terms that existed prior to the incentive program.
On February 1, 2007, subsequent to the conclusion of the incentive
program, the Company had 196.8 million common shares outstanding, 32.6
million warrants outstanding, 16.7 million stock options outstanding and
debentures potentially convertible into 14.2 million common shares.
About Pennsaid(R)
Pennsaid(R) is a topical non-steroidal anti-inflammatory drug (NSAID)
used for the treatment of osteoarthritis and is currently approved for sale
in Canada and several European countries. Pennsaid(R) allows the diclofenac
solution 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(R) 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 is currently no topical NSAID product approved in the
approximately $4 billion U.S. osteoarthritis pain relief market. In
December 2006, the U.S. Food and Drug Administration issued an approvable
letter that indicated Pennsaid(R) is approvable subject to Nuvo satisfying
certain conditions.
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(R), a topical non-steroidal
anti-inflammatory drug (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 manufacturing facilities in
Varennes, Quebec and Wanzleben, Germany and a research and development
facility in San Diego, California. For more information, please visit
nuvoresearch.
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.
Nuvo Research Inc.
nuvoresearch
View drug information on Pennsaid.
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