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, call 1-866-949-9277.
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 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.