Nuvo licenses Pennsaid in parts of CIS to NovaMedica

Nuvo Research Inc. and NovaMedica LLC, a Russian pharmaceutical company, have signed a supply and distribution agreement providing NovaMedica the exclusive rights to market and sell Nuvo's Pennsaid 1.5 per cent and Pennsaid 2 per cent products in Russia and some of the Commonwealth of Independent States.

Pennsaid 1.5 per cent and Pennsaid 2 per cent are used to treat the symptoms and pain of osteoarthritis of the knee. Pennsaid 1.5 per cent is approved by the U.S. Food and Drug Administration and is currently being marketed in the United States, Canada and certain European countries. A new drug application for Pennsaid 2 per cent is currently under review by the FDA which has indicated that it expects to respond to the NDA by Feb. 7, 2014.

Under the terms of the agreement, NovaMedica is responsible for conducting required clinical studies and obtaining regulatory approval for the products in the licensed territories. Sales of Pennsaid 1.5 per cent in Russia are projected to begin in 2015.

"With an established sales force and excellent knowledge of the Russian pharmaceutical market, NovaMedica is the ideal commercial partner to obtain approval for and market Pennsaid 1.5 per cent and Pennsaid 2 per cent in Russia," said Dan Chicoine, chairman and co-chief executive officer of Nuvo. "Pennsaid 1.5 per cent is currently marketed in five countries, and we will continue to expand its market potential by seeking marketing partners throughout the world."

"This agreement brings together the advanced expertise and innovative scientific potential of Nuvo Research and our clinical, regulatory and commercial capabilities in Russia, an ideal combination to bring this innovative drug to Russian and CIS patients. We expect these products have a big potential to become an effective and safe solution for unmet needs in our markets," said Fabrice Egros, chief operating officer of NovaMedica. "Our company is committed to contribute to the improvement of Russian health care and will continue to address the Russian market with innovative medicines."

Pennsaid is used to treat the signs and symptoms associated with knee osteoarthritis. The drug combines the transdermal carrier (containing dimethyl sulphoxide, popularly known as DMSO) with 1.5 per cent diclofenac sodium, a non-steroidal anti-inflammatory drug and delivers the active drug through the skin directly to the site of inflammation and pain. Pennsaid is currently marketed in the United States by Mallinckrodt Inc., in Canada by Paladin Labs Inc. and marketed under licence and/or distribution agreements in Greece, Italy and the United Kingdom.

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