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Richter’s Esmya Receives EU Approval for Treatment of Myomas

Feb. 27 (Bloomberg) -- Gedeon Richter Nyrt., Hungary’s largest drugmaker, said its Esmya drug received marketing authorization by the European Union for the pre-operative treatment of myomas.

“We see Esmya’s annual sales peaking at around 100 million euros ($134.3 million) after an introductory period of three years,” Zsuzsa Beke, Richter’s communications director, said in a phone interview. The market introduction of the new drug will be gradual, with sales scheduled to start in Germany and the U.K. in April 2012, she said.

Esmya was developed by PregLem, a Swiss biopharmaceutical company wholly owned by Richter, according to a statement published on the website of the Budapest Stock Exchange today.

Richter, central and eastern Europe’s largest producer of gynecological products, got Esmya in 2010 when it bought Switzerland’s PregLem for 445 million Swiss francs ($496 million). The medicine may be the first of a new type of treatment for uterine fibroids, or myomas, which affect about 40 percent of women between the age of 35 and 55 and can cause heavy bleeding, pain and infertility.

“This is particularly good news and it’s the first big step toward Richter becoming a leading global drugmaker,” Erste Bank AG said in an e-mailed research note today.

License Fee

Watson Pharmaceuticals Inc. agreed in 2010 to pay Richter a $17 million license fee to develop and market Esmya in the U.S. and Canada. Richter faces a milestone payment of around 150 million Swiss francs for Esmya, Beke said.

Richter shares rose as much as 0.5 percent to 38,190 forint and were trading at 38,100 at 09:41 a.m. in Budapest, outperforming the benchmark BUX index, which declined 0.7 percent. The stock has advanced 11.4 percent this year.

Sales of Esmya may start in Spain and Italy in 2013 while roll-out to central and eastern European markets as well as former Soviet states hinges on the registration process, Beke said.

To contact the reporter on this story: Edith Balazs in Budapest at

To contact the editor responsible for this story: James M. Gomez at

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