Basilea Pharmaceutica AG (BSLN), a Swiss developer of an antibiotic to treat pneumonia, said the U.S. Food and Drug Administration asked for more data before approving the drug. The stock fell as much as 12 percent.
Basilea doesn’t plan to start the new late-stage clinical trials of its ceftobiprole without a partner for the U.S., the Basel-based company said in a statement today.
The decision is a setback for ceftobiprole, which will become available in some European markets in the second half of this year. The drugmaker had been in talks with “many” companies for a partnership and plans to contact them again now that the FDA’s guidance is clear, Chief Executive Officer Ron Scott said in a phone interview.
Basilea shares traded 7.5 percent lower at 106.80 Swiss francs at 10:49 a.m. in Zurich.
The drugmaker will announce a plan on how to sell the treatment in Europe -- either with a partner or through a contract sales network -- when it reports first-half results on Aug. 14 , Scott said.
Basilea also intends to file for approval in Europe in the middle of this year for isavuconazole, a treatment for invasive aspergillosis and mucormycosis, two fungal infections. Scott said he also anticipates a mid-year filing in the U.S. from Astellas Pharma Inc. (4503), the Swiss company’s partner on the drug.
That means a decision on approval is possible in the U.S. in the first quarter and in Europe in the third quarter of next year, Scott said. The two drugs present many “synergies” as there’s an overlap of patients who need them, the CEO said.
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