Novalar Pharmaceuticals has entered into an exclusive license and distribution agreement with Sanofi-Aventis Deutschland to offer its vasodilator drug phentolamine mesylate, OraVerse, in Germany beginning in 2011, the companies announced.
The agreement includes options to extend the license to additional European countries. 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.
"We are eager to add OraVerse to our portfolio of product offerings," said Peter Guenter, general manager of commercial operations at Sanofi-Aventis Deutschland, in a press release. "This collaboration provides us with an opportunity to launch a first-in-class dental product in Germany."
OraVerse is a local anesthesia reversal agent that accelerates the return of normal sensation and function following routine dental procedures. It is cleared for use in the U.S. by the FDA and sold by Novalar direct to dentists.
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