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Last updated on April 17, 2014 at 17:30 EDT

Nuvo Research announces European launch of Pliaglis(R) by Galderma

April 23, 2013

MISSISSAUGA, ON, April 23, 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 Pharma, S.A.
(Galderma), today announced the European 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.  Marketing licenses have been issued in 14
of the 16 European countries which are listed in the European Marketing
Application for Pliaglis.

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.  In the E.U. Pliaglis is indicated in adults
to produce local dermal anaesthesia on intact skin prior to
dermatological procedures.

Galderma launched Pliaglis in Argentina in 2011 and in the U.S. in March
2013 and anticipates that it will launch in Canada and a number of
Central American, South American and Asian countries in 2014 and 2015.

“We are proud in being able to bring additional comfort to patients in
Aesthetic treatments,” said Mr. Didier Leclercq, Managing Director of
Galderma Aesthetic & Corrective Center of Excellence. “Pliaglis really
sets a new standard in topical anesthetics, and is a great
complementary product in our already comprehensive Aesthetic portfolio
in Europe. ”

“The launch of Pliaglis in the E.U. is yet another important and
exciting milestone for Nuvo,” said Dr. Bradley Galer, President of
Nuvo’s Pain Group. “Galderma has an excellent launch plan for the
countries of Europe to introduce the benefits of Pliaglis to physicians
who provide aesthetic services to their patients.”

Important Safety Information

Indication: PLIAGLIS® (lidocaine and tetracaine) Cream 7% / 7% is indicated in
adults to produce local dermal anaesthesia on intact skin prior to
dermatological procedures.  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. Pliaglis should not be used on mucous membranes or on broken
or irritated skin.  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.  The
treated area should not be occluded before removing Pliaglis from the
skin.

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.

About Galderma

Galderma is a global company founded in 1981 committed to delivering
innovative medical solutions to meet the dermatological needs of people
throughout their lifetime while serving healthcare professionals around
the world. The company has 31 wholly-owned affiliates with a worldwide
network of distributors and more than 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.

With approximately 20% 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 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(®), Restylane(® )and Emervel(®).

Forward-Looking Statements

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 Financial
Statements and Management’s Discussion and Analysis, as well as in
Nuvo’s Annual Information Form for the year ended December 31, 2012. 
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.


Source: PR Newswire