Richter Gedeon Nyrt, eastern Europe's biggest maker of gynecological drugs, may get up to $5 million in added revenue this year if U.S. regulators approve over-the-counter sales of an emergency contraceptive it makes. Barr Pharmaceuticals Inc.’s CEO Bruce Downey said sales of Plan B could double if the drug was available without a prescription. Richter, based in Budapest, makes Plan B for Barr. The U.S. Food and Drug Administration (FDA) said yesterday it wants to meet with Barr within the next week to discuss the possibility of allowing over-the-counter sales of its Plan B „morning after” pill. The drug had been expected to contribute $4 million to $5 million to Richter's revenue this year, according to Péter Tordai, an analyst at the Budapest branch of KBC Groep NV. Richter's sales would double along with Barr's, meaning Plan B could contribute as much as $10 million, he said. "We are happy to see that there are some positive steps in the approval process,” Richter spokeswoman Zsuzsa Beke said, adding that the debate surrounding over-the-counter sales of Plan B has been going on for three years. Beke declined to confirm KBC's numbers, though she said Plan B sales in the U.S. were expected to amount to "a few million dollars” this year. She also said it was "dangerous" to base a sales forecast on the possibility that the FDA might allow Plan B to be sold over the counter. "This is a kind of political fight before the November elections," she said. "The U.S. is such a radically conservative society that it's difficult to assess" how well Plan B would sell over the counter, she added. Many US politicians oppose sales of Plan B on moral and religious grounds. The FDA would limit over-the-counter sales to women 18 and older. Richter markets Plan B as Levonelle-2 in the European Union and as Rigesoft in Hungary. The company had sales of Ft 140.9 billion ($705.5 million) last year, with just under 10% of revenue coming from U.S. exports. Sales of gynecological drugs made up about 28% of Richter's sales in H1. (Bloomberg)
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