(Updates price, adds detail, CEO and analyst comment)
ZURICH, June 25 (Reuters) - Shares in Swiss biotech company Basilea fell by as much as 11.5 percent in early trading on Wednesday following a setback to its efforts to gain U.S. approval for its ceftobiprole treatment for pneumonia.
The company said in a statement on Wednesday it had been told by the U.S. Food and Drug Administration (FDA) that potential regulatory approval of ceftobiprole, a broad-spectrum intravenous antibiotic, to treat pneumonia would require additional phase 3 data.
Basilea said it did not intend to begin new final stage trials for the treatment without a partner in the United States.
“I need to be able to see what the response from potential partners is with the clear indication from the FDA that we will have to do additional trials,” Basilea Chief Executive Ronald Scott told Reuters.
The emergence of hospital superbugs has increased the need for new effective treatments and refocused attention on antibiotics. Last year, ceftobiprole was given the green light by European regulators to treat MRSA, the methicillin-resistant Staphylococcus aureus.
“We are planning to launch ceftobiprole in initial countries in Europe towards the end of the year,” Scott said.
He added the FDA decision has no financial impact on the company’s guidance.
“(Basilea) has an extraordinary pipeline of new products,” J. Safra Sarasin analyst Rainer Skierka, who has a “buy” rating on the stock, wrote in a note. “Furthermore, it is a matter of time that a partner in the US will be found.”
At 0835 GMT shares in Basilea were trading down 6.85 percent at 107.50 Swiss francs. (Reporting by Joshua Franklin and Paul Arnold. Editing by Jane Merriman)