(Reuters) - Finland’s Orion and Germany’s Bayer said on Wednesday the U.S. Food and Drug Administration (FDA) had approved prostate cancer drug daroluramide, which the two companies have been developing together.
“The compound was approved under the FDA Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions,” Orion said.
According to the 2014 deal Bayer has the right to commercialize daroluramide globally while Orion will manufacture the product and receive milestone payments upon first sale in different markets.
Earlier this year Orion defined darolutamide as its most important growth driver for the next few years, and said it was eligible to receive a milestone payment of 45 million euros ($50 million) upon first commercial sales in the United States.
Orion said Bayer has filed for approval of the compound also in the European Union, Japan and with other health authorities.
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Reporting by Tarmo Virki in Tallinn; Editing by David Holmes