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Basilea reveals positive phase III data for ceftobiprole

Basilea reveals positive phase III study data for its antibiotic ceftobiprole for the treatment of hospital-acquired pneumonia

Swiss pharmaceutical company Basilea has revealed positive phase III study data for its antibiotic ceftobiprole for the treatment of hospital-acquired pneumonia (HAP).

Ceftobiprole is the first anti-MRSA (methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin to complete phase III clinical trials and is being co-developed with Johnson & Johnson Pharmaceutical Research and Development (J&JPRD).

The trial met the primary endpoint of non-inferiority, compared with combination therapy of a ceftazidime plus a linezolid. The study included a subgroup of patients with microbiologically and clinically more complex ventilator-associated pneumonia (the consolidated protocol from two former HAP trials).

Overall, 69 per cent of the clinically evaluable (CE) patients were cured with ceftobiprole compared with 72 per cent of patients treated with combination therapy. The study met the non-inferiority criteria in both CE and intent-to-treat populations.

In the CE patient population excluding VAP clinical cure rates were 77 per cent for ceftobiprole and 76 per cent for combination therapy.

Cure rates in the smaller VAP patient subset (about 25 per cent of patients enrolled) were lower for ceftobiprole treated patients and non-inferiority could not be established. Further analyses are ongoing.

Ceftobiprole was generally well tolerated. The rate of overall adverse events was comparable between the two treatment groups. The adverse event profile of ceftobiprole was consistent with previous phase III studies and that of the cephalosporin class.

"We are delighted with the preliminary results of this hospital-acquired pneumonia trial. According to recent publications, community-acquired pneumonia (CAP) and non-ventilator-associated pneumonia account for up to 90 per cent of pneumonia patients in the hospital setting. The results of this study together with the recently announced positive top-line results from the trial in CAP requiring hospitalisation will form the basis of further regulatory submissions," commented Dr. Anthony Man, CEO of Basilea.

Ceftobiprole is currently under review by regulatory authorities in the US, the EU and Canada for the treatment of complicated skin and skin structure infections.

According to Datamonitor, the total value of the hospital antibacterial market is USD 9.9bn, but generic price erosion caused a slump between 2003 and 2006. Within the market, a core group of products, which accounting for USD 5.7bn have maintained a modest growth of three per cent.

High numbers of Gram-positive targeted products imply very distinct winners and losers. Astellas' Arbelic Cubicin and Zeven have strong commercial backing, but oritavancin, ceftaroline and subsequent entrants will find that generic incursion combined with the marketing might of strong entrants form a formidable barrier to the success, added Datamonitor.

30th September 2008

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