• Cariprazine sales in U.S. may help offset declines in Europe
  • Ipopema analyst sees Richter sales jumping up to 30% by 2019

Hungarian drugmaker Gedeon Richter Nyrt., hit by eroding sales in some of its European markets, headed for the biggest gain in five months after U.S. authorities granted approval for an anti-psychotic drug developed jointly with Allergan Plc.

The U.S. Food and Drug Administration approved the registration of cariprazine under the name Vraylar for the treatment of schizophrenia and bipolar disorder, rewarding research efforts that started as early as 1998.

Richter’s shares jumped 3.3 percent to 4,450 forint by 9:19 a.m. in Budapest, the most on a closing basis since April 27 and extending this year’s advance to 26 percent. That compares with a 28 percent gain in the benchmark BUX Index in the same period.

"The decision paves the way for Richter to become a specialty drugmaker in the long-term," Norbert Harcsa, a Budapest-based analyst at Ipopema Securities SA, said by e-mail. "The drug could add 30 percent to revenue by 2019 and may make the U.S. Richter’s largest market."

Richter and its Dublin-based research partner Allergan, which was created through a merger with Actavis Plc, received FDA approval for the drug on the second try after the U.S. authority requested additional clinical trial data in 2013. The largest producer of contraceptive pills in central and eastern Europe has been relying on exports to western Europe, China and Latin America to counter its shrinking sales in Ukraine and other former Soviet states.

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