MISSISSAUGA, ON, March 11, 2013 /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 the U.S. launch of Pliaglis (lidocaine and tetracaine) Cream
7%/7%. 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. Pliaglis
was brought back to the market in the U.S. after the U.S. Food and Drug
Administration (FDA) approved a supplemental New Drug Application in
October 2012 filed by Galderma.
"The introduction of Pliaglis marks the next step of Galderma's growth
in the aesthetic & corrective area," said Francois Fournier, President
of U.S. and Canada for Galderma Laboratories, L.P. "Galderma is more
than ever committed to delivering innovative medical solutions to meet
the dermatological needs of people throughout their lifetime while
serving healthcare professionals."
"We are excited to announce the U.S. launch of Pliaglis by our partner
Galderma," said Dr. Bradley Galer, President of Nuvo's Pain Group.
"Pliaglis' efficacy, safety, rapid onset of action and ease of use
promises to greatly improve the experience of patients by providing
analgesia while they are undergoing superficial dermatologic and
Important Safety Information
Indication: PLIAGLIS® (lidocaine and tetracaine) 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. Contraindications: 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 and is also contraindicated in patients with
sensitivity to para-aminobenzoic (PABA) or any components of the
product. Adverse Events: In clinical studies, the most common local reactions were erythema
(47%), skin discoloration (16%), and edema (14%). 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 severe hepatic disease. When using PLIAGLIS® Cream in
conjunction with other local anesthetic agents, the total dose of
anesthetic should be considered due to the potential for additive
systemic toxic effects. 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®, Tri-Luma® 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.