Pliaglis® is a topical local anesthetic cream that provides safe and effective local dermal anesthesia on intact skin prior to superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal. This product consists of a proprietary formulation of lidocaine and tetracaine that utilizes proprietary Phase Changing Topical Cream Peel Technology.

Pliaglis should be applied to intact skin for 20-30 minutes prior to superficial dermatological procedures, such as a dermal filler injection or facial laser ablation, and for 60 minutes prior to dermatological procedures, such as laser-assisted tattoo removal. Following the application period, Pliaglis can easily be removed from the skin and the procedure can be performed with minimal to no pain.

Galderma Pharma S.A. (Galderma), a global specialty pharmaceutical company focused on dermatology, holds the worldwide sales and marketing rights for Pliaglis. Pliaglis is approved for sale and marketing in Argentina.

Pliaglis was approved by the U.S. Food and Drug Administration (FDA) in June 2006 and was voluntarily removed from the U.S. market in 2008, due to manufacturing issues at Galderma’s contract manufacturer.  In early 2012, the FDA accepted the supplemental New Drug Application (sNDA) for Pliaglis for review.  On April 16, 2012, the FDA issued a Complete Response Letter (CRL) to the sNDA.  On May 8, 2012, Nuvo announced that Galderma submitted additional information that it believes addresses all of the issues outlined in the CRL. The additional information relates to the manufacturing transfer of Pliaglis from a third-party contract manufacturer to Galderma’s manufacturing facility and includes additional stability data and proposed labeling revisions.  The CRL did not require any new clinical or toxicology studies.  It is expected the FDA will apply a 4-month review period for this information.

In July 2011, a Marketing Authorization Application (MAA) for Pliaglis was submitted to 17 E.U. countries using the decentralized submission procedure and is under active review. On May 7, 2012, the Company announced that it has received notice of a positive opinion from the European Decentralized Procedure for the approval of Pliaglis from the German Federal Institute for Drugs and Medical Devices (BfArM), the reference member state. The decentralized procedure has been closed with a positive recommendation that Pliaglis is approvable for the indication of producing local dermal anesthesia on intact skin in adults prior to superficial dermatological procedures.

The regulatory process will now enter its final phase known as the national licensing phase. During this phase, the National Agencies in the individual countries will issue the marketing licenses that allow Pliaglis to be marketed in each country. The individual country licenses will be issued directly to Galderma.

Galderma was advised by Health Canada on February 2012, that its New Drug Submission for Pliaglis has been accepted for review. In September 2011, Galderma filed marketing applications in Switzerland and Brazil and is expected to file for marketing approval in other countries around the world, including additional South American countries, select Asian countries, South Africa, and Australia.

U.S residents, please click here to read additional information regarding Pliaglis - www.pliaglis.com