Sanofi-Aventis to commercialize Novalar's OraVerse in Germany

French drug major Sanofi-Aventis and USA-based Novalar Pharmaceuticals have entered into an exclusive license and distribution agreement in which Sanofi-Aventis Deutschland will have the right to commercialize and market Novalar's OraVerse in Germany with options to extend the license to additional European countries.

OraVerse is the first and only local anesthesia reversal agent that accelerates the return of normal sensation and function following routine dental procedures. OraVerse is approved for use in the USA by the Food and Drug Administration and sold by Novalar direct to dentists.

The parties will collaborate to submit the Marketing Authorization Application (MAA) in 2010 in several European countries with an anticipated approval in Germany by 2011. Sanofi-Aventis will be responsible for the launch of OraVerse in Germany, and Novalar will be responsible for supplying product under a supply agreement between the parties. In consideration for the license, Sanofi-Aventis will pay Novalar a combination of upfront and milestone payments in addition to royalties on product sales. Further financial details were not disclosed.