Nuvo Research Inc. (TSX:NRI) announced that it obtained an additional U.S. patent for Pennsaid 2%, an improved follow-on formulation of its currently marketed Pennsaid product. Pennsaid contains the anti-inflammatory drug diclofenac, which is applied on the skin for pain conditions such as osteoarthritis of the knee. Pennsaid is currently marketed by Covidien’s (NYSE:COV) pharmaceutical division Mallinkrodt, and Pennsaid 2% is undergoing FDA review for approval. The new version is a higher strength version of the product, and is formulated to increase the penetration of diclofenac through the skin to the site of pain. Importantly, the new formulation, if approved, will have patent protection out to 2028, and could become an important product for Covidien’s pharmaceutical division, which is expected to be spun out to COV shareholders as a pure-play company in mid-2013. In July, Nuvo and Covidien announced that the FDA had accepted their New Drug Application (NDA) for Pennsaid 2% with a PDUFA (FDA action) date of March 4, 2013. Covidien stated that once Pennsaid 2% is approved, it expects to have the new patent listed in the FDA’s Orange Book
NRI shares remain on the radar screen, but could gain visibility on its portfolio of products for the topical treatment of pain. In addition to Covidien, the company is partnered with leading dermatology company Galderma, which is gearing up for approval and launch of Pliaglis. Pliaglis is Nuvo’s topical anesthetic cream that will be marketed by Galderma for the reduction of pain associated with dermatological procedures. Several European countries have already notified Galderma that Pliaglis has been approved, and Galderma has responded to a Complete Response Letter (CRL) in the U.S. for potential FDA approval. Nuvo is also re-launching its Synera product, a topical anesthetic patch approved in the U.S. to provide pain relief for superficial dermatological procedures, and the company may seek to partner the drug in major markets. With only a $31 million market cap, shares of Nuvo Research have substantial room to run as U.S. investors become more familiar with the company.