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. Novalar will be responsible for supplying product to Sanofi-Aventis 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.

Novalar’s OraVerse is the local anesthesia reversal agent that accelerates the return of normal sensation and function following restorative and periodontal maintenance dental procedures. OraVerse is approved for use in the FDA and sold by Novalar directly to dentists.

OraVerse is indicated for the reversal of soft tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. OraVerse is indicated for use only in adults and children 6 years of age or older and weighing at least 15 kg (33 lbs).

Peter Guenter, general manager of commercial operations at Sanofi-Aventis Deutschland, said: “Sanofi-Aventis is a leading pharmaceutical company in Germany with a strong dental franchise. We are eager to add OraVerse to our portfolio of product offerings, which includes our market-leading local anesthetic Ultracain. This collaboration provides us with an opportunity to launch a first-in-class dental product in Germany.”

Donna Janson, president and chief executive officer at Novalar, said: “Sanofi-Aventis is the ideal partner to lead the OraVerse sales and marketing efforts in Europe. They not only bring strong brand recognition and expertise in the European regulatory process but also demonstrated success in the dental industry. As the largest dental market for local anesthetics in Europe, Germany represents a significant opportunity for the introduction of OraVerse. The commercial network of Sanofi-Aventis will enable rapid penetration and reach into the target market.”