Nuvo Research Inc. (NRI), a specialty pharmaceutical company with a diverse portfolio of products in the areas of topical pain and immunology, 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% 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 US, 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. “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."
The Pennsaid drug combines the transdermal carrier (containing dimethyl sulfoxide, popularly known as DMSO) with 1.5% diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) 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 license and/or distribution agreements in Greece, Italy and the United Kingdom.
Pennsaid 2% is a follow-on product to original Pennsaid. Pennsaid 2% contains 2% diclofenac sodium compared to 1.5% for original Pennsaid. It is more viscous than original Pennsaid, is supplied in a metered dose pump bottle and was studied in clinical trials using twice daily dosing compared to four times a day for original Pennsaid. In August 2013, Mallinckrodt advised Nuvo that the FDA accepted a resubmission of a New Drug Application (NDA) for Pennsaid 2% for review and set a Prescription Drug User Fee Act (PDUFA) date of February 7, 2014 for action on the submission.
Nuvo is focused on improving patient’s lives by developing and commercializing innovative products that address unmet medical needs.
NovaMedica, a portfolio company of Domain Associates LLC, and Russian investment corporation RUSNANO, which implements government policy on the development of hi-tech industries. NovaMedica’s strategy is aimed at localizing production of a wide range of new medicines and technologies in the Russian market, including screening and registration, and the creation of innovative GMP-standard manufacturing facilities.