Nuvo Research Inc. (NRI.TO)'s Pliaglis Receives Positive Opinion from the BfArM in the E.U.
5/7/2012 7:20:08 AM
MISSISSAUGA, ON, May 7, 2012 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a
specialty pharmaceutical company dedicated to building a portfolio of
products for the topical treatment of pain and the development of its
immune modulating drug candidate WF10, today announced that it has
received notice of a positive opinion from the European Decentralized
Procedure for the approval of Pliaglis from the German Federal
Institute for Drugs and Medical Devices (BfArM), the reference member
state. The decentralized procedure has been closed with 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 Marketing Authorization Application (MAA) was submitted by Nuvo to
17 E.U. countries using the decentralized submission procedure to
request marketing approval for Pliaglis. The regulatory process will
now enter its final phase known as the national licensing phase. During
this phase, the National Agencies in the individual countries will
issue the marketing licenses that allow Pliaglis to be marketed in each
country. Nuvo has licensed worldwide marketing rights for Pliaglis to
Galderma S.A. (Galderma), a global pharmaceutical company specialized
in dermatology and the individual country licenses will be issued
directly to Galderma. Pursuant to Nuvo's license agreement with
Galderma, Nuvo is entitled to receive milestone payments totaling
US$6.0 million when certain specified launches occur or within a
predefined 6-month period after marketing approval in three different
"We are very pleased that Pliaglis has received a positive
recommendation to the MAA supporting its approval in many key European
markets," stated Dr. Bradley Galer, President of Nuvo's Pain Group.
"This successful result reflects the highly cooperative effort between
Nuvo and Galderma."
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., a Covidien
company, 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
S.A., a global specialty pharmaceutical company specialized in
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.
Galderma is a global pharmaceutical company founded in 1981 and
exclusively focused on dermatology. The company has 31 wholly-owned
affiliates with a worldwide network of distributors and 4,000
employees. Galderma's extensive product portfolio is available in 70
countries and treats a range of dermatological conditions including:
acne, rosacea, onychomycosis, psoriasis & steroid-responsive
dermatoses, pigmentary disorders, skin cancer and medical solutions for
skin senescence. In 2011, Galderma acquired Q-Med, a Swedish medical
device company specialized in aesthetics, strengthening Galderma's
presence in the aesthetic and corrective market. With approximately 19%
of revenues invested each year to discover and develop new products and
access innovative technologies, the company is one of the world's
leading investors in dermatology R&D. Four state-of-the-art R&D
centers, of which Sophia Antipolis in France is one of the largest
dermatology sites in the world, and four manufacturing sites, are
dedicated to providing a wide range of innovative medical solutions
which meet the highest standards of safety and efficacy. Strategic
brands include Epiduo, Oracea, Clobex, Differin, Rozex/MetroGel,
Silkis/Vectical, Tri-Luma, Loceryl, Cetaphil, Metvix, Azzalure,
Dysport*, Restylane and Emervel.
*Dysport is a trademark of Ipsen
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, 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 www.sedar.com.
SOURCE Nuvo Research Inc.