Nuvo Research Inc. and NovaMedica LLC (NovaMedica) have announced that they have signed a supply and distribution agreement providing NovaMedica the exclusive rights to market and sell Nuvo's Pennsaid 1.5% and Pennsaid 2% products in Russia and some of the Community of Independent States (CIS).
Pennsaid 1.5% and Pennsaid 2% are used to treat the symptoms and pain of osteoarthritis of the knee. Pennsaid 1.5% is approved by the U.S. Food and Drug Administration (FDA) and is currently being marketed in the U.S., Canada and certain European countries.
A new drug application (NDA) for Pennsaid 2% is currently under review by the FDA which has indicated that it expects to respond to the NDA by February 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% 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% and Pennsaid 2% in Russia," said Dan Chicoine, Chairman and Co-CEO of Nuvo.
Chicoine continued, "Pennsaid 1.5% 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, COO 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."