MISSISSAUGA, ON, July 5, 2011 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a
specialty pharmaceutical company dedicated to building a portfolio of
products for the topical treatment of pain, today announced that its
Marketing Authorization Application (MAA) for Pliaglis has been
validated in the European Union (EU). The MAA was submitted using the
decentralized procedure to request marketing approval for Pliaglis for
the indication of producing local dermal anaesthesia on intact skin in
adults prior to superficial dermatological procedures. Worldwide
marketing rights for Pliaglis have been licensed to Galderma Pharma S.
A., a global specialty pharmaceutical company focused on dermatology.
"Our optimism regarding approval of Pliaglis in Europe was important in
our decision to acquire ZARS Pharma, Inc. Validation of the MAA by
regulatory agencies in Europe is an important step towards approval and
launch of Pliaglis in key European markets," stated Dan Chicoine,
Chairman & Co-Chief Executive Officer of Nuvo. "Based on the timing of
the filing, Pliaglis remains on track for approval and launch in a
number of EU countries in 2012."
Validation of the Pliaglis MAA for review indicates that the submitted
application is complete and ready for review. The MAA was filed in
Germany as the Reference Member State and also with regulatory
authorities in Austria, Belgium, Denmark, Greece, Spain, Finland,
France, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland,
Portugal, Sweden and the UK as Concerned Member States. The regulatory
agency in each of these countries will evaluate the application to
determine whether to recommend approval for the marketing of Pliaglis.
Upon approval, the marketing application will be transferred from Nuvo
to Galderma, which can then commence launch activities in each approved
Pliaglis is a topical local anesthetic cream, which uses the Company's
proprietary phase-changing topical peel technology. Pliaglis'
marketing rights have been licensed worldwide to Galderma Pharma S.A.,
a global specialty pharmaceutical company focused on dermatology.
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical
company, headquartered in Mississauga, Ontario. The Company is
building a portfolio of products for the treatment of pain through
internal research and development and by in-licensing and acquisition.
The Company's Pain Group, located in West Chester, Pennsylvania, is
focused on the development and commercialization of topically delivered
pain products. The company's product portfolio includes Pennsaid®,
Pliaglis and Synera®. Pennsaid, a topical non-steroidal
anti-inflammatory drug (NSAID), is used to treat the signs and symptoms
of osteoarthritis of the knee. Pennsaid is sold in the United States
by Mallinckrodt Inc., a Covidien company (NYSE: COV), in Canada by
Paladin Labs Inc. (TSX:PLB) and in several European countries. Pliaglis
is a topical local anesthetic cream, which is U.S. Food and Drug
Administration (FDA) approved to provide topical local analgesia for
superficial dermatological procedures. The Company has licensed
worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a
global specialty pharmaceutical company focused on dermatology. Synera
is a topical patch that combines lidocaine, tetracaine and heat,
approved in the United States to provide local dermal analgesia for
superficial venous access and superficial dermatological procedures and
in Europe, for surface anaesthesia of normal intact skin. Nuvo
currently markets Synera in the United States and its licensing
partner, EuroCept International B.V., has initiated a pan-European
launch of Synera (under the name Rapydan) in several European
countries. Through its subsidiary, Nuvo Research GmbH, based in
Leipzig, Germany, the Company is also developing the compound WF10, for
the treatment of immune related diseases. For more information, please
This document contains forward-looking statements. Some forward-looking
statements may be identified by words like "expects", "anticipates",
"plans", "intends", "indicates" or similar expressions. These
forward-looking statements, by their nature, necessarily involve risks
and uncertainties that could cause actual results to differ materially
from those contemplated by the forward-looking statements. Nuvo
considers the assumptions on which these forward-looking statements are
based to be reasonable at the time they were prepared, but caution that
these assumptions regarding future events, many of which are beyond the
control of the Company, may ultimately prove to be incorrect. Factors
and risks, which could cause actual results to differ materially from
current expectations, are discussed in the annual report, as well as in
Nuvo's Annual Information Form for the year ended December 31, 2010.
Nuvo disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information or
future events, except as required by law. For additional information on
risks and uncertainties relating to these forward looking statements,
investors should consult the Company's ongoing quarterly filings,
annual report and Annual Information Form and other filings found on
SEDAR at www.sedar.com.
SOURCE Nuvo Research Inc.