Nuvo Research® and NovaMedica sign agreement to market Pennsaid® in Russia
MISSISSAUGA, ON and MOSCOW, Dec. 19, 2013
MISSISSAUGA, ON and MOSCOW, Dec. 19, 2013 /PRNewswire/ - Nuvo Research Inc.
(TSX: NRI), a specialty pharmaceutical company with a diverse portfolio of
products in the areas of topical pain and immunology, and NovaMedica LLC
(NovaMedica), a Russian pharmaceutical company, today announced that they have
signed a supply and distribution agreement providing NovaMedica the exclusive
rights to market and sell Nuvo's Pennsaid 1.5% and Pennsaid 2% products in
Russia and some of the Community of Independent States (CIS).
Pennsaid 1.5% and Pennsaid 2% are used to treat the symptoms and pain of
osteoarthritis of the knee. Pennsaid 1.5% is approved by the U.S. Food and
Drug Administration (FDA) and is currently being marketed in the U.S., Canada
and certain European countries. A new drug application (NDA) for Pennsaid 2%
is currently under review by the FDA which has indicated that it expects to
respond to the NDA by February 7, 2014.
Under the terms of the agreement, NovaMedica is responsible for conducting
required clinical studies and obtaining regulatory approval for the products
in the licensed territories. Sales of Pennsaid 1.5% in Russia are projected to
begin in 2015.
"With an established sales force and excellent knowledge of the Russian
pharmaceutical market, NovaMedica is the ideal commercial partner to obtain
approval for and market Pennsaid 1.5% and Pennsaid 2% in Russia," said Dan
Chicoine, Chairman and Co-CEO of Nuvo. "Pennsaid 1.5% is currently marketed
in five countries, and we will continue to expand its market potential by
seeking marketing partners throughout the world."
"This agreement brings together the advanced expertise and innovative
scientific potential of Nuvo Research and our clinical, regulatory and
commercial capabilities in Russia, an ideal combination to bring this
innovative drug to Russian and CIS patients. We expect these products have a
big potential to become an effective and safe solution for unmet needs in our
markets," said Fabrice Egros, COO of NovaMedica. "Our company is committed to
contribute to the improvement of Russian health care and will continue to
address the Russian market with innovative medicines."
About Pennsaid 1.5%
Pennsaid is used to treat the signs and symptoms associated with knee
osteoarthritis (OA). The drug combines the transdermal carrier (containing
dimethyl sulfoxide, popularly known as DMSO) with 1.5% diclofenac sodium, a
non-steroidal anti-inflammatory drug (NSAID) and delivers the active drug
through the skin directly to the site of inflammation and pain. Pennsaid is
currently marketed in the United States by Mallinckrodt Inc., in Canada by
Paladin Labs Inc. and marketed under license and/or distribution agreements in
Greece, Italy and the United Kingdom.
About Pennsaid 2%
Pennsaid 2% is a follow-on product to original Pennsaid. Pennsaid 2% contains
2% diclofenac sodium compared to 1.5% for original Pennsaid. It is more
viscous than original Pennsaid, is supplied in a metered dose pump bottle and
was studied in clinical trials using twice daily dosing compared to four times
a day for original Pennsaid. In August 2013, Mallinckrodt advised Nuvo that
the FDA accepted a resubmission of a New Drug Application (NDA) for Pennsaid
2% for review and set a Prescription Drug User Fee Act (PDUFA) date of
February 7, 2014 for action on the submission.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company focused on improving
patient's lives by developing and commercializing innovative products that
address unmet medical needs. Nuvo has a diverse portfolio of products in the
areas of topical pain and immunology.
Nuvo's marketed products include Pennsaid^® (a topical treatment for the signs
and symptoms of osteoarthritis of the knee), Pliaglis (a topical local
anesthetic) and the heated lidocaine/tetracaine patch (HLT Patch). For
additional Company information visit www.nuvoresearch.com.
NovaMedica is a Russian pharmaceutical company established in 2012 by DRI
Holdings Limited, a portfolio company of Domain Associates LLC, and Russian
investment corporation RUSNANO, which implements government policy on the
development of hi-tech industries. NovaMedica's strategy is aimed at
localizing production of a wide range of new medicines and technologies in the
Russian market, including screening and registration, and the creation of
innovative GMP-standard manufacturing facilities. www.novamedica.com.
Certain statements in this news release constitute forward-looking statements
within the meaning of applicable securities laws. Forward-looking statements
include, but are not limited to, statements concerning Nuvo's future
objectives, strategies to achieve those objectives, as well as statements with
respect to management's beliefs, plans, estimates, and intentions, and similar
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forward-looking statements reflect management's current beliefs and are based
on information currently available to management. Forward-looking statements
involve risks and uncertainties that could cause actual results to differ
materially from those contemplated by such statements. Factors that could
cause such differences include the need for additional financing, the current
economic environment, dependence on sales and marketing partnerships,
competitive developments, as well as other risk factors included in Nuvo's
annual information form dated March 27, 2013 under the heading "Risks Factors"
and as described from time to time in the reports and disclosure documents
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This list is not exhaustive of the factors that may impact Nuvo's
forward-looking statements. These and other factors should be considered
carefully and readers should not place undue reliance on Nuvo's
forward-looking statements. As a result of the foregoing and other factors,
no assurance can be given as to any such future results, levels of activity or
achievements and neither Nuvo nor any other person assumes responsibility for
the accuracy and completeness of these forward-looking statements. The
factors underlying current expectations are dynamic and subject to change.
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based upon what management believes are reasonable assumptions, there can be
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qualified by these cautionary statements. The forward-looking statements
contained herein are made as of the date of this news release and except as
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or revise any forward-looking statement, whether as a result of new
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SOURCE Nuvo Research Inc.
Director of Public Relations
Tel: +7 916025 9610
Nuvo Research Inc.
Director, Investor Relations & Corporate Communications
Tel: +1 (905) 673-3617
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