BioWorld International Correspondent

Shares in Basilea Pharmaceutica AG hit an all-time high on the Swiss Stock Exchange in Zurich last Friday of CHF240 (US$192), on good news about its broad-spectrum cephalosporin antibiotic ceftobiprole. Research analysis showed that ceftobiprole attained the primary endpoint of statistical non-inferiority versus a comparator combination therapy in a Phase III pivotal trial in patients with complicated skin and skin structure infection (cSSSI).

According to topline results from the study of 828 patients, ceftobiprole attained a clinical cure rate of 91 percent among clinically evaluable patients, versus a rate of 90 percent for those on a combination therapy consisting of the cephalosporin antibiotic ceftazidime plus vancomycin. Patients were randomized on a 2:1 basis to receive ceftobiprole or the combination regimen. The trial encompassed subjects with Gram-positive or Gram-negative infections.

About one-third of the patients had diabetic foot infections, Basilea said. The clinical response rate in the subgroup was 86 percent for those on ceftobiprole versus 82 percent for those on combination therapy.

The trial also confirmed previous findings of the compound's activity versus methicillin-resistant Staphylococcus aureus (MRSA). Some 20 percent of the clinically evaluable patients had confirmed MRSA infection, and in those cases, ceftobiprole attained a clinical cure rate of 91 percent versus 86 percent for the comparator treatment.

The Basel, Switzerland-based company and its development partner, Cilag GmbH International, a subsidiary of Johnson & Johnson Co., of New Brunswick, N.J., remain on track to file for approval this year, and analysts expect them to launch the compound during 2008.

The current trial is the second pivotal study Basilea has completed with ceftobiprole. It previously attained statistical non-inferiority versus vancomycin only in a trial of cSSSI in patients with Gram-positive infections. A third Phase III trial, in patients with nosocomial pneumonia, is ongoing.

Basilea gained outright ownership of ceftobiprole in 2004 when Basel-based F. Hoffmann-La Roche Ltd. - from which it had been spun out in 2000 - decided not to pick up an option on the compound. It subsequently entered a co-development agreement with Johnson & Johnson, which was worth up to CHF370 million in up-front and milestone payments. It also retained an option to co-promote the product. (See BioWorld International, Feb. 9, 2005.)

Robin Campbell, analyst at London-based Jefferies International Ltd., upped his target price on the stock from CHF210 to CHF275. "The increasing probability of getting through to market in not only complicated skin infection but also in diabetic foot ulcer has pushed the stock up strongly," he told BioWorld International. "They've made quite a bit of the diabetic foot opportunity."

Campbell is forecasting sales of about $1.5 billion for ceftobiprole five or six years after launch. In addition to selling ceftobiprole through its planned sales force, the company also may be able to commercialize two other late-stage pipeline products through the same channel.

A Phase III clinical trial of the antifungal drug isavuconazole is due to report data in the current quarter, and the compound is as yet unpartnered. Alitretinoin, a vitamin A derivative in development for chronic hand dermatitis, is due to enter a Phase III study shortly. "I think the major priority now is to decide what to do with the antifungal," Campbell said.