Pliaglis Receives Positive Opinion from the BfArM in the E.U.
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Nuvo Research Inc. has 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 Marketing Authorization Application (MAA) was submitted by Nuvo to 17 E.U. countries using the decentralized submission procedure to request marketing approval for Pliaglis.
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.
Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma S.A. (Galderma), a global pharmaceutical company specialized in dermatology and the individual country licenses will be issued directly to Galderma.
Pursuant to Nuvo's license agreement with Galderma, Nuvo is entitled to receive milestone payments totaling US$6.0 million when certain specified launches occur or within a predefined 6-month period after marketing approval in three different countries.
"We are very pleased that Pliaglis has received a positive recommendation to the MAA supporting its approval in many key European markets," stated Dr. Bradley Galer, President of Nuvo's Pain Group. "This successful result reflects the highly cooperative effort between Nuvo and Galderma."
