Nuvo Research Inc. (NRI.TO) and Galderma Pharma S.A. Announce FDA Approval of Pliaglis
10/22/2012 7:17:38 AM
MISSISSAUGA, ON, Oct. 22, 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 Galderma Laboratories,
L.P., the U.S. affiliate of Galderma Pharma, S.A. (Galderma), today
announced that the U.S. Food and Drug Administration (FDA) has approved
a supplemental New Drug Application (sNDA) for Pliaglis®
(lidocaine/tetracaine) 7%/7% Cream. Nuvo has licensed worldwide
marketing rights for Pliaglis to Galderma, a global pharmaceutical
company specialized in dermatology.
Pliaglis is a topical local anesthetic cream that uses Nuvo's
proprietary phase-changing technology to form a pliable peel on the
skin when exposed to air. Pliaglis is indicated for use on intact skin
in adults to provide local analgesia for superficial aesthetic
procedures, such as dermal filler injection, pulsed dye laser therapy,
facial laser resurfacing and laser-assisted tattoo removal.
"We are very pleased that the sNDA for Pliaglis has been approved by the
FDA," said Francois Fournier, President of U.S. and Canadian operations
of Galderma Laboratories. "Pliaglis offers a pre-treatment solution and
contributes to improving the patient experience of an aesthetic
"This is yet another significant milestone for Nuvo this year," said Dr.
Bradley Galer, President of Nuvo's Pain Group. "Pliaglis is an
important part of Nuvo's expanded topical pain product portfolio."
Important Safety Information
Indication: PLIAGLIS® Cream 7% / 7% is indicated for use on intact skin in adults
to provide topical local analgesia for superficial dermatological
procedures such as dermal filler injection, pulsed dye laser therapy,
facial laser resurfacing, and laser-assisted tattoo removal. Adverse Events: In clinical studies, the most common local reactions were erythema
(47%), skin discoloration (16%), and edema (14%). These reactions were
generally mild and transient, resolving spontaneously soon after
treatment. The most common systemic adverse events were headache,
vomiting, dizziness, and fever, all of which occurred with a frequency
of <1%. Warnings/Precautions: Methemoglobinemia has been associated with use of local anesthetics
such as tetracaine. PLIAGLIS® Cream should be used with caution in
patients with sensitivity to any of its components, including
para-aminobenzoic acid (PABA), and in patients with severe hepatic
disease. PLIAGLIS® Cream is contraindicated in patients with a known
history of sensitivity to lidocaine or tetracaine, or local anesthetics
of the amide or ester type. When using PLIAGLIS® Cream in conjunction
with other local anesthetic agents, the total dose of anesthetic should
be calculated. Contact with the eyes should be avoided.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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
Pharma 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. Further
more information, please visit www.nuvoresearch.com.
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 in the US include Epiduo®, Oracea®,
Clobex®, Differin®, MetroGel®, Vectical® and Cetaphil®. For more
information, please visit www.galdermausa.com.
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 www.sedar.com.
SOURCE Nuvo Research Inc.