Sanofi-Aventis Deutschland GmbH and Novalar Pharmaceuticals, Inc. announced today that they 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 U.S. 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. 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.
"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," said Peter Guenter, General Manager Commercial Operations at Sanofi-Aventis Deutschland. "This collaboration provides us with an opportunity to launch a first-in-class dental product in Germany."
"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," said Donna Janson, President and Chief Executive Officer at Novalar. "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."