Basilea superbug drug gets standard U.S. review
(Recasts, adds analyst comment, shares, details)
ZURICH, July 18 (Reuters) - Swiss biotech company Basilea (BSLN.S) said on Wednesday U.S. and European authorities had accepted its filing for a new drug to fight superbugs, but the United States would not give it an accelerated review.
Basilea said Ceftobiprole, a broad spectrum antibiotic to treat deadly superbug MRSA, would be subject to a standard review by the U.S. Food and Drug Administration. Analysts had expected a faster, six-month review period.
"We now expect Ceftobiprole approval in March/April 2008," Morgan Stanley said in a note.
By 1002 GMT, shares in the group, which have gained some 30 percent so far this year, had fallen 1 percent to 272 Swiss francs.
The emergence of so-called hospital superbugs such as MRSA, which are resistant to existing medicines, has increased the need for alternative treatments and refocused attention on antibiotics.
"Although disappointing, this decision does not change our view on the potential of the drug," Morgan Stanley said.
The regulatory dossiers for Ceftobiprole for complicated skin and soft tissue infections were submitted by Basilea's co-development partner Johnson & Johnson (JNJ.N) in the United States and in Europe by its license partner Janssen-Cilag International, Basilea said.
((Reporting by Katie Reid, editing by Erica Billingham/Sue Thomas;
e-mail: katie.reid@reuters.com
Reuters Messaging:katie.reid.reuters.com@reuters.net
telephone: +41 (0) 44 631 7320)) Keywords: BASILEA CEFTOBIPROLE/
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