ZURICH Shares in Swiss biotech firm
Basilea(BSLN.S) tanked after the firm failed to get approval
from the U.S. Food and Drug Administration for its ceftobiprole
broad spectrum antibiotic to treat the deadly superbug MRSA.
The FDA only issued an approvable letter, indicating that
the drug application was approvable, subject to further
assessment of clincial study and data, Basilea said in a
Basilea shares lost nearly 30 percent in early trade and
were down 21 percent by 0857 GMT at 146.80 Swiss francs.
The firm said it was closely working with its development
partner Johnson & Johnson (JNJ.N) to address the questions from
the FDA quickly.
U.S. authorities had granted the drug a standard review in
July, disappointing hopes of an accelerated review, and
analysts had expected approval by March or April 2008.
Basilea chief executive Anthony Man told journalists in a
telephone conference that he could not speculate about the
timeframe for a FDA approval.
"The FDA may have more questions (after the review of
already submitted data)," Man said.
The emergence of hospital superbugs such as MRSA, which are
resistant to existing medicines, has increased the need for
alternative treatments and re-focused attention on antibiotics.
(Reporting by Sven Egenter and Paul Arnold; Editing by