» » Sanofi-Aventis, Novalar Pharma File Marketing Application For Dental Anesthesia Reversal Agent In Five European Countries – Update

Sanofi-Aventis, Novalar Pharma File Marketing Application For Dental Anesthesia Reversal Agent In Five European Countries – Update

(RTTNews) – Specialty pharmaceuticals company Novalar Pharmaceuticals, Inc. and Sanofi-Aventis Deutschland GmbH, a unit of Sanofi-Aventis (SNY), Wednesday said their marketing authorization application for OraVerse, a dental anesthesia reversal agent, has been accepted for review by the regulatory agencies of the 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 directly to U.S. dentists.

Novalar’s President and Chief Executive Officer Donna Janson said, “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.”

The company noted that dentists in the five key countries included in the dossier utilize about 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 US. The application will follow the Decentralized Procedure for obtaining marketing authorization in select European countries, with the UK as the Reference Member State or RMS and Germany, Italy, France and Spain as Concerned Member States or CMS.

The RMS is responsible for interfacing with the applicant, developing the assessment reports, and obtaining comments from the CMS.

In March, Sanofi-Aventis announced an exclusive license and distribution agreement with Novalar to commercialize and market OraVerse in Germany with options to extend the license to additional European countries.

In Tuesday’s regular trading session, SNY closed trading at $30.98 per share on the NYSE.

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