Nuvo and Galderma Win FDA Approval For Pliaglis Topical Peel
Canadian-based Nuvo Research (TSE:NRI) announced Monday morning that the FDA has approved its Pliaglis product, a unique local anesthetic designed to minimize pain during aesthetic dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. Importantly, Pliaglis is partnered with Galderma, a leading global dermatology company, and today’s news is key because it demonstrates that Nuvo and its partner were able to successfully address all of the issues in the prior Complete Response Letter (CRL) issued by the FDA. The product is a topical local anesthetic cream that uses Nuvo’s proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. Earlier this year, Galderma stated that several European countries have approved Pliaglis, suggesting a global launch of the product by year-end.
NRI.TO now has three approved products, two of which are backed by significant partners. Mallinkrodt, the pharmaceutical division of Covidien plc (NYSE:COV) sells Pennsaid, a topical pain cream developed by the company. A new higher strength formula, Pennsaid 2%, is undergoing FDA review with a PDUFA (FDA Action) date of March 4, 2014. Pennsaid 2% is not only designed to offer better pain relief, but it also will extend patent life of the Pennsaid franchise out to 2028. Because COV’s pharmaceutical division is anticipated to be spun out as a stand-alone company in mid-2013, the marketing push behind Pennsaid, among other Mallinkrodt products, is likely to increase. Synera is NRI.TO’s third approved product, which is a topical anesthetic patch approved for children and adults to numb the skin prior to needle procedures. The company is exploring strategies to increase the market uptake of this asset. As visibility for the company increases, a U.S. listing for the shares becomes a distinct possibility. Expect shares of NRI.TO to trade higher today on the news of the Pliaglis approval.