Nuvo Research Inc. has announced that Galderma S.A. (Galderma), a global company dedicated to dermatology has received its first three Pliaglis marketing licenses from E.U. countries.
These licenses entitle Nuvo to receive a total of US$6.0 million of milestone payments from its worldwide Pliaglis marketing partner, Galderma.
The milestone payments are due on the earlier of the launch of Pliaglis in the approved countries or 6 months from the date of marketing approval.
The payments are expected in December 2012 (US$5.0 million) and January 2013 (US$1.0 million).
Galderma has advised Nuvo that it expects to launch Pliaglis in the E.U. and other territories in the first half of 2013.
Nuvo previously filed a Marketing Authorization Application (MAA) for the approval of Pliaglis in 16 E.U. countries using the European Decentralized Procedure and on May 4, 2012 received 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 then entered its final phase during which individual countries issue marketing licenses that allow Pliaglis to be marketed in each country.
Nuvo expects to receive marketing licenses from the other E.U. countries over the next 12 months.
"We are extremely pleased that Pliaglis is in the process of being approved in a number of E.U. countries and that Nuvo is receiving a substantial regulatory milestone payment as a result," said Dr. Bradley Galer, President of Nuvo's Pain Group.
Dr. Galer continued, "The upcoming launch of Pliaglis will mean that Nuvo will have 3 growing sources of revenue from globally commercialized topical pain products."