Galenica AG, the world’s biggest maker of iron replacement drugs, fell to the lowest in more than four months after the U.S. Food and Drug Administration withheld approval of its Injectafer treatment.
Galenica dropped 3.7 percent to 554.5 Swiss francs, the lowest since March 8, cutting the Bern, Switzerland-based company’s market value to 3.6 billion francs ($3.7 billion). The stock has lost 11 percent since July 20, when Vontobel Holding AG lowered its rating on the company, saying it would probably face a delay in gaining approval for the drug.
The regulator’s decision was related to a factory in Shirley, New York, owned by Luitpold Pharmaceuticals, where Injectafer would be made for the U.S. market, Galenica said in a statement today. The FDA didn’t ask for any additional information on the drug itself.
“During a recent inspection, deficiencies in the manufacturing facility were noted by the FDA inspectors,” Galenica said. “The FDA requires satisfactory resolution of these deficiencies before the application for Injectafer can be approved. Luitpold Pharmaceuticals is working closely with the FDA to resolve these deficiencies.”
Luitpold, a unit of Tokyo-based Daiichi Sankyo Co., holds U.S. marketing rights for Injectafer. The drug is sold outside the U.S. as Ferinject.