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.
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.