(Updates price, adds detail, CEO and analyst comment)
ZURICH, June 25 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
"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
"(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