June 30, 2008 / 7:19 AM / 10 years ago

UPDATE 3-Basilea superbug drug approved in Canada

(Adds analyst comment)

ZURICH, June 30 (Reuters) - Basilea’s BLSN.S superbug drug ceftobiprole received approval for the first time after Canadian health authorities gave it the green light, the Swiss biotech company said on Monday, pushing its shares higher.

Health Canada has authorized use of the drug for the treatment of complicated skin and soft-tissue infections, including diabetic foot infections, Basilea said in a statement.

The drug, which Basiliea has co-developed with Johnson & Johnson (JNJ.N) through its Janssen-Cilag unit, will be sold under the Zeftera brand name.

By 1012 GMT, shares in the group were up 0.5 percent at 165.60 Swiss francs, outperforming a 1.1 percent weaker Swiss mid-cap index .SMIM.

The Basel-based company came under pressure in March after ceftibiprole, a broad based spectrum antibiotic to treat deadly superbug MRSA, failed to win approval from the U.S. Food and Drug Administration.

The FDA only issued an approvable letter at the time, indicating that the drug was subject to further assessment of clincial study and data.

“In our view, the approval in Canada thus increases the likelihood of full approval in the U.S. and Europe, although by history the decision in the U.S. does not always correlate with the decision in other jurisdictions,” said Vontobel analyst Markus Metzger.

Ceftobiprole is under review by regulatory authorities in the United States, the European Union, Australia, Russia, South Africa and Switzerland.

The emergence of hospital superbugs such as MRSA, which are resistant to existing medicines, has increased the need for alternative treatments and refocused attention on antibiotics. (Reporting by Andrew Thompson; Editing by Louise Ireland)

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