Sanofi-Aventis Deutschland and Novalar Pharmaceuticals said that the regulatory authorities of the UK, Germany, Italy, France and Spain have accepted to review the marketing authorisation application (MAA) of OraVerse.
Earlier, in March 2010, Novalar and Sanofi-Aventis signed a license and distribution agreement for OraVerse.
The FDA approved OraVerse is indicated for reversal of the soft-tissue anesthesia and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor.
Novalar and Sanofi-Aventis said that the application will follow the decentralised procedure for obtaining marketing authorisation in select European countries, with the UK as the Reference Member State (RMS) and Germany, Italy, France and Spain as Concerned Member States (CMS).
The RMS is responsible for interfacing with the applicant, developing the assessment reports, and obtaining comments from the CMS.
Under the contract between both the entities Sanofi-aventis is expected to take the responsibility for the launch of OraVerse in Germany upon approval and retains options to extend the license to all European countries.
Whereas, Novalar is eligible for an additional milestone payment upon approval, royalties on product sales in the territory and pre-determined option exercise fees for each additional country added to the license.
Donna Janson, president and CEO of Novalar, said: “Expansion of OraVerse into Europe represents a significant near-term opportunity for Novalar, and it is our goal to obtain marketing approval by mid-2011.
“Dentists in the five key countries included in the dossier utilise approximately 270 million cartridges of local dental anesthetic each year, which is about 75% of the total local anesthetic usage in all of Europe.”