Novalar Strikes Deal With Sanofi to Market Dental Drug in Germany, Maybe Rest of EU

3/3/10Follow @xconomy

Novalar has convinced one of the world’s biggest drugmakers, Paris-based Sanofi-Aventis, that it might be onto something.

The San Diego-based biotech is announcing today that it has struck a partnership in which Sanofi’s unit in Germany will have exclusive marketing rights to the vasodilator drug phentolamine mesylate (OraVerse) in that country, plus an option to extend the license to other European countries. Novalar already markets the drug to dentists in the U.S., and the two companies plan to seek approval in Europe later this year. Novalar will get an undisclosed upfront payment, plus milestones, and double-digit percentage royalties on sales in Europe.

Novalar’s drug, which I first wrote about in November 2008, is designed to reverse the numbing effect of local anesthesia that dentists give. It’s supposed to help increase blood flow to tissues like the lips, gums, and cheeks, so that the numbing agents wear off in about half the time. The drug has gotten off to a slower start in the U.S. marketplace than Novalar had initially hoped, and it more recently got slapped on the wrist by the FDA for publishing a marketing brochure that regulators thought overstated the drug’s benefits and minimized risks. (Novalar says it has quit using the brochure in question).

By branching into Europe and working with Sanofi, Novalar says it has hitched its wagon to a company that has about 80 percent share in Germany’s local anesthesia market. The dental anesthesia market is worth 30 million Euros annually in Germany. The whole of Europe represents a big opportunity, since an estimated 270 million anesthesia cartridges are sold there per year—about the same as in the U.S.

Novalar is currently marketing its drug in its original six regions of the U.S.—New York, California, Texas, Florida, Illinois, and the Baltimore/Washington, DC area, says CEO Donna Janson. She didn’t disclose the company’s U.S. sales in 2009, or say whether Novalar plans to introduce its product across the entire country in 2010. But Janson says she’s “quite pleased” with how the product is doing, and its potential growth in Europe.

“Sanofi-Aventis is the perfect partner to lead OraVerse,” Janson says. “A lot of people know they are the No. 4 pharmaceutical company in the world overall, but a lot of people don’t know they are the largest dental pharmaceutical company in Germany.”

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