Galen to acquire U.S. rights for Synera® from Nuvo Research®
MISSISSAUGA, ON and SOUDERTON, PA, July 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
Galen US Incorporated, today announced that Nuvo and Nuvo’s wholly
owned subsidiary, ZARS Phama, Inc. and Galen have entered into a
product acquisition and license agreement for Galen to acquire the
exclusive rights to market and sell Nuvo’s Synera patch throughout the
United States for its current indication. Synera is a topical patch
that combines lidocaine, tetracaine and heat and is U.S. Food and Drug
Administration (FDA) approved to provide local dermal analgesia for
superficial venous access and superficial dermatological procedures,
such as excision, electrodessication and shave biopsy of skin lesions.
Under the terms of the agreement, Galen has made an upfront payment to
Nuvo of US$4.5 million. Nuvo will receive royalties of 10% of net sales
and is eligible to receive a US$5 million milestone payment upon gross
annual sales reaching US$25 million and a further US$5 million upon
gross annual sales reaching US$50 million. Galen has acquired the U.S.
rights to the current FDA approved indication for Synera. Nuvo retains
the right to develop and seek FDA approval for future additional
indications including acute musculoskeletal pain.
“We are pleased that our new partner, Galen will be selling Synera in
the U.S.,” said Dr. Bradley Galer, President of Nuvo’s Pain Group. “We
believe the resources that Galen will deploy to increase Synera U.S.
sales will significantly benefit both partners.”
Galen’s General Manager in the U.S., Andrew Shales, commented, “This
acquisition will enable us to market and sell Synera in the U.S. to
help address an important medical need in the field of local dermal
analgesia, especially in children 3 years or older, within this vast
geographic market. Indeed, demand is stoked by hospitalized patients
being routinely subjected to multiple superficial venous access
procedures such as IV infusions and blood draws. Galen entered the U.S.
market back in 2012 and this new product provides us with the
opportunity to offer an innovative technology to patients that need
local dermal analgesia.”
Synera (lidocaine 70 mg/tetracaine 70 mg) topical patch is a combination
amide and ester local anesthetic topical patch indicated for use on
intact skin to provide local dermal analgesia for superficial venous
access and superficial dermatological procedures such as excision,
electrodessication and shave biopsy of skin lesions. Synera is not yet
FDA approved for any other indications.
Important Safety Information
Synera should only be applied to intact skin, for use in adults and
children of 3 years and older.
The product is contraindicated in patients with a known history of
sensitivity to lidocaine, tetracaine, or local anesthetics of the amide
or ester type. Synera is also contraindicated in patients with
para-aminobenzoic acid (PABA) hypersensitivity and in patients with a
known history of sensitivity to any other component of the product.
Keeping a patch on longer than recommended or applying multiple patches
simultaneously or sequentially could result in systemic absorption
sufficient to result in serious adverse effects that are typical of
drugs in this class.
Even a used Synera patch contains a large amount of lidocaine and tetracaine (at
least 90% of the initial amount). Chewing or ingesting a new or used
Synera patch may result in serious adverse effects. Store and dispose
of Synera out of the reach of children and pets. In clinical studies,
the most common skin reactions were generally mild application site
reactions such as redness, blanching, and swelling. Allergic reactions
such as hives, difficulty breathing, skin redness or swelling, and
shock can occur.
Refer to the full Prescribing Information at www.synera.com for additional Important Safety Information and before prescribing
Synera. Synera is a prescription drug. 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 (1-800-332-1088). If you have a medical
information inquiry or wish to report a side effect relating to Synera,
Full prescribing information is available at: www.synera.com/sites/default/files/files/Synera_PI.pdf.
About Nuvo Research Inc.
Nuvo 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. 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., 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 pharmaceutical company specialized in dermatology. Galderma
launched the marketing and sale of Pliaglis in the U.S. in March of
2013 and in the E.U. in April of 2013. 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
WF10, for the treatment of immune related diseases.
Galen US Incorporated is a wholly owned subsidiary of Galen Limited, a
privately owned, global pharmaceutical company headquartered in
Craigavon, UK. It has expertise in marketing a broad range of
therapies including those in the constipation, urology, angina and
hypertension areas. Until recently Galen has focused on promoting
branded and generic prescription medicines in the United Kingdom and
Ireland. Around 150 staff based in the Craigavon site carry out work
for Galen, providing essential services including specialist support
for research and development, as well as manufacture and distribution
of medical products. Its products are now available in 16 countries
and the company continues to work to expand its global reach through
international strategic partnerships.
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
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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
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These and other factors should be considered carefully and readers
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SOURCE Nuvo Research Inc.