, July 19, 2012
/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
Galderma S.A. (Galderma), a global company dedicated to dermatology has
received its first three Pliaglis marketing licenses from E.U.
countries These licenses entitle Nuvo to receive a total of US$6.0
of milestone payments from its worldwide Pliaglis marketing
partner, Galderma. The milestone payments are due on the earlier of the
launch of Pliaglis in the approved countries or 6 months from the date
of marketing approval. The payments are expected in December 2012
) and January 2013
). Galderma has
advised Nuvo that it expects to launch Pliaglis in the E.U. and other
territories in the first half of 2013.
Nuvo previously filed a Marketing Authorization Application (MAA) for
the approval of Pliaglis in 16 E.U. countries using the European
Decentralized Procedure and on May 4, 2012 received a positive
recommendation that Pliaglis is approvable for the indication of
producing local dermal anesthesia on intact skin in adults prior to
superficial dermatological procedures. The regulatory process then
entered its final phase during which individual countries issue
marketing licenses that allow Pliaglis to be marketed in each country.
Nuvo expects to receive marketing licenses from the other E.U.
countries over the next 12 months.
"We are extremely pleased that Pliaglis is in the process of being
approved in a number of E.U. countries and that Nuvo is receiving a
substantial regulatory milestone payment as a result," said Dr. Bradley
Galer, President of Nuvo's Pain Group. "The upcoming launch of Pliaglis
will mean that Nuvo will have 3 growing sources of revenue from
globally commercialized topical pain products."
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 product portfolio includes Pennsaid®, Pliaglis and Synera®. Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID), is
used to treat the signs and symptoms of osteoarthritis of the knee(s).
Pennsaid is sold in the United States by Mallinckrodt Inc., the
Pharmaceuticals business of Covidien, in Canada by Paladin Labs Inc.
and in several European countries. Pliaglis is a topical local
anesthetic cream which provides topical local analgesia for superficial
dermatological procedures. The Company has licensed worldwide marketing
rights to Pliaglis to Galderma Pharma S.A., a global company dedicated
to 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. The Company is also developing the compound WF10,
for the treatment of immune related diseases.
Forward-Looking Statements for Nuvo Research Inc.
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 Company's Annual Report, as well as in Nuvo's Annual
Information Form for the year ended December 31, 2011. 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
SOURCE Nuvo Research Inc.