UPDATE 2-Basilea superbug drug hits FDA hurdle, shares drop

ZURICH, Dec 30 (Reuters) - Swiss biotech Basilea's plans to launch a superbug-beating antibiotic in the United States face a fresh delay after regulators there questioned key data and refused to accept a regulatory filing.

Basilea shares plunged 20 percent to 61 Swiss francs on the news by 0920 GMT on Wednesday, having already lost nearly half their value this year following various setbacks on ceftobiprole.

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.

But the U.S. Food and Drugs Administration (FDA) concluded it could not approve the application for ceftobiprole in its present form due to concerns about data integrity for two key studies by drug sponsor Johnson & Johnson, Basilea said.

The response 'means a further delay of ceftobiprole's entry to the US market. Depending on the outcome of the discussions with the FDA we reckon the delay could be three years,' said Vontobel analyst Silvia Schanz in a research note.

The FDA said the studies into the drug, which is intended to treat complicated skin and skin structure infections (cSSSI), could not be relied on.

J&J had failed to properly monitor clinical investigators' conduct, and two 'new, adequate and well-controlled studies' were needed to evaluate the drug's safety and effectiveness in treating such infections, Basilea quoted the regulator as saying.



FURTHER SETBACK

U.S. regulators had already delayed a decision on approval of the broad-based spectrum antibiotic to treat MRSA last year, saying they needed further audits of clinical sites, prompting a sharp fall in Basilea shares.

The Swiss group then filed a claim against J&J over the delays after the approval process hit a setback in Europe.

Basilea said the latest delay would increase its damage claims in the arbitration it requested in February. In Frankfurt, J&J shares traded flat.

Basilea was now reviewing all strategic options to protect the interests of the company and its shareholders.

A regulatory review of ceftobiprole in the EU is ongoing. An opinion by the EU Committee for Medicinal Products for Human Use is anticipated in the first quarter of 2010, Basilea said.

Earlier this month French drug major Sanofi-Aventis SA licensed an antibody against MRSA from developer Alopexx Pharmaceuticals that is scheduled to enter Phase I studies in 2010.

(Reporting by Sven Egenter and Martin de Sa'Pinto; editing by Simon Jessop, John Stonestreet) Keywords: BASILEA/ ([e-mail]; +41.58.306.7351; Reuters Messaging: [e-mail]) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.