OraVerse MAA accepted for review in five key European countries

Jul 14 2010

Sanofi-Aventis Deutschland GmbH and Novalar Pharmaceuticals, Inc. today announced that the Marketing Authorization Application (MAA) for OraVerse has been accepted for review by the regulatory agencies of the United Kingdom (UK), Germany, Italy, France and Spain.  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 U.S. dentists.

"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," said Donna Janson, President and Chief Executive Officer of Novalar.  "Dentists in the five key countries included in the dossier utilize approximately 270 million cartridges of local dental anesthetic each year, which is about 75% of the total local anesthetic usage in all of Europe.  Germany is by far the largest single market for local anesthetic usage and Sanofi-Aventis leads the market with its anesthetic Ultracain®."  

The proposed indication for OraVerse in Europe is comparable to the product's approved indication in the United States.  The application will follow the Decentralized Procedure for obtaining marketing authorization in select European countries, with the UK as the Reference Member State (RMS) and Germany, Italy, France and Spain as Concerned Member States (CMS).  The RMS is responsible for interfacing with the applicant, developing the assessment reports, and obtaining comments from the CMS.

In March 2010, Novalar and Sanofi-Aventis announced an exclusive license and distribution agreement for OraVerse.  Since that time, the partners have collaborated extensively to successfully submit the MAA and will continue to do so throughout the review process. Under the terms of the agreement, Sanofi-Aventis will be responsible for the launch of OraVerse in Germany upon approval and retains options to extend the license to all European countries.  Novalar is eligible for an additional milestone payment upon approval, royalties on product sales in the territory and pre-determined option exercise fees for each additional country added to the license.