Sanofi-aventis’ OraVerse accepted for European regulatory review

Sanofi-aventis has had its local anaesthesia reversal agent OraVerse accepted for regulatory review in a number of European nations.

Authorities in the UK, Germany, Italy, France and Spain have all agreed to consider the treatment, which has been developed by Novalar Pharmaceuticals, for marketing approval.

The treatment is said to be the first anaesthesia reversal agent designed to accelerate the return of normal sensation and function following routine dental procedures.

Should it be approved, Sanofi-aventis will take responsibility for its German launch and holds an option to extend the licence to all European territories.

Donna Janson, president and chief executive officer of Novalar, added: “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.”

Earlier this month, Sanofi-aventis’ vaccines subdivision Sanofi Pasteur agreed to transfer certain product rights and licences to Crucell in a restructuring of their longstanding partnership.