Friday, June 22, 2007

Basilea Superbug Filed For European Approval

Basilea Pharmaceutica AG (BSLN.EB) said Monday its superbug antibiotic has been submitted for European approval, prompting a milestone payment of 12 million Swiss Francs ($9.8 million) for the Basel-based company.

Basilea said the anti-infective treatment ceftobiprole was submitted to the European Medicines Agency by a subsidiary of Johnson & Johnson (JNJ), with whom Basilea will sell the treatment in the U.S. and major European countries.

"Today's marketing authorization application submission as well as the recent new drug application filing in the USA reflect our view that ceftobiprole could play an important role globally in the future management of important medical problems posed by methicillin-resistant Staphylococcus aureus," Basilea's Chief Executive Anthony Man said in a statement.

The filing, in keeping with Basilea's pledge to submit the treatment this year, follows favorable study date from January, where the treatment was shown to be effective against complicated skin infections.

In January, Basilea said ceftobiprole demonstrated high cure rates in a range of patients, including those with methicillin-resistant Staphylococcus aureus, or MRSA, and diabetics with foot infections.

Basilea shares, which jumped earlier this year after the most recent data from ceftobiprole, have gained 28% this year, giving the company a market capitalization of $2 billion.

The stock closed at CHF272 Friday; trading resumes at 0700 GMT Monday.

Ceftobiprole is in Phase-III testing to treat patients who develop pneumonia while in hospital, as well as community-acquired pneumonia, for which Basilea expects results in the latter half of 2007.

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