MISSISSAUGA, ON and MOSCOW, Dec. 19, 2013 /CNW/ - 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.
About NovaMedica
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.
Forward-Looking Statements
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 statements concerning
anticipated future events, results, circumstances, performance or
expectations that are not historical facts. Forward-looking statements
generally can be identified by the use of forward-looking terminology
such as "outlook", "objective", "may", "will", "expect", "intend",
"estimate", "anticipate", "believe", "should", "plans" or "continue",
or similar expressions suggesting future outcomes or events. Such
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 filed by Nuvo with Canadian securities regulatory agencies
and commissions. 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.
Although the forward-looking information contained in this news release
is based upon what management believes are reasonable assumptions,
there can be no assurance that actual results will be consistent with
these forward-looking statements. Certain statements included in this
news release may be considered "financial outlook" for purposes of
applicable securities laws, and such financial outlook may not be
appropriate for purposes other than this news release. All
forward-looking statements in this news release are qualified by these
cautionary statements. The forward-looking statements contained herein
are made as of the date of this news release and except as required by
applicable law, Nuvo undertakes no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
SOURCE Nuvo Research Inc.
