Milestone Payment Related to Pliaglis Brazil Approval and Launch
MISSISSAUGA, ON, Oct. 10, 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 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
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.
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®.
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.