Milestone Payment Related to Pliaglis Brazil Approval and
Launch
MISSISSAUGA, ON, Oct. 10, 2013 /CNW/ - 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 the Company has been advised by its worldwide
Pliaglis licensing partner, Galderma S.A. (Galderma), that Pliaglis
has been approved for sale and marketing in Brazil and that it expects to launch Pliaglis
in Brazil in early 2014. This
entitles Nuvo to a US$2.0 million
milestone payment that it expects to receive from Galderma in early
2014.
"We are pleased that Pliaglis has been approved
for sale and marketing in Brazil
which is one of the largest potential markets for Pliaglis," said
Dr. Bradley Galer, President of
Nuvo's Pain Group. "Pliaglis is now approved for sale and
marketing in 16 European countries, the
United States, Argentina
and Brazil with additional
approvals expected over the next two years."
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 (TSX:NRI) is a specialty pharmaceutical
company focused on improving patient's lives by developing and
commercializing innovative products that address unmet medical
needs. The Company has a diverse portfolio of products in the
areas of topical pain and immunology.
Nuvo's marketed products include
Pennsaid® (a topical treatment for the signs and
symptoms of osteoarthritis of the knee), Pliaglis (a topical local
anesthetic) and the heated lidocaine/tetracaine patch (HLT
Patch). For additional Company information 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
33 wholly-owned affiliates with a worldwide network of distributors
and more than 4,500 employees. Galderma's extensive product
portfolio is available in 80 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 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. Five 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
Certain statements in this news release
constitute forward-looking statements within the meaning of
applicable securities laws. Forward-looking statements
include, but are not limited to, statements concerning the
Company's future objectives, strategies to achieve those
objectives, as well as statements with respect to management's
beliefs, plans, estimates, and intentions, and similar statements
concerning anticipated future events, results, circumstances,
performance or expectations that are not historical facts.
Forward-looking statements generally can be identified by the use
of forward-looking terminology such as "outlook", "objective",
"may", "will", "expect", "intend", "estimate", "anticipate",
"believe", "should", "plans" or "continue", or similar expressions
suggesting future outcomes or events. Such forward-looking
statements reflect management's current beliefs and are based on
information currently available to management.
Forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
contemplated by such statements. Factors that could cause
such differences include the need for additional financing, the
current economic environment, dependence on sales and marketing
partnerships, competitive developments, as well as other risk
factors included in the Company's annual information form dated
March 27, 2013 under the heading
"Risks Factors" and as described from time to time in the reports
and disclosure documents filed by the Company with Canadian
securities regulatory agencies and commissions. This list is
not exhaustive of the factors that may impact the Company's
forward-looking statements. These and other factors should be
considered carefully and readers should not place undue reliance on
the Company's forward-looking statements. As a result of the
foregoing and other factors, no assurance can be given as to any
such future results, levels of activity or achievements and neither
the Company nor any other person assumes responsibility for the
accuracy and completeness of these forward-looking
statements. The factors underlying current expectations are
dynamic and subject to change. Although the forward-looking
information contained in this news release is based upon what
management believes are reasonable assumptions, there can be no
assurance that actual results will be consistent with these
forward-looking statements. Certain statements included in
this news release may be considered "financial outlook" for
purposes of applicable securities laws, and such financial outlook
may not be appropriate for purposes other than this news
release. All forward-looking statements in this news release
are qualified by these cautionary statements. The
forward-looking statements contained herein are made as of the date
of this news release and except as required by applicable law, the
Company undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
SOURCE Nuvo Research Inc.