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Cubist publishes positive data on novel antibiotic

Sivextro offers once-daily alternative for skin infections
Cubist pharma

Cubist has reported positive clinical results for its new antibiotic Sivextro, which is currently under regulatory review in both Europe and the US.

The phase III study - reported online by The Lancet Infectious Diseases - indicates that Sivextro (tedizolid phosphate) was at least as effective in the treatment of acute bacterial skin and skin structure infections (ABSSSI) as Pfizer's Zyvox (linezolid).

Like Zyvox, Sivextro is in the oxazolidinone class but can be dosed orally once-daily compared to twice-a-day for Pfizer's drug. Despite generally being often reserved for last-line use in multidrug resistant infections, Zyvox has been a big success commercially for Pfizer and looks set to achieve sales of around $1.2bn this year.

In the phase III trial reported this week, researchers successfully showed that patients with serious ABSSSI infections could be started on intravenous Sivextro and then safely transitioned to an oral regimen. Six days of treatment with Cubist's drug was non-inferior to 10 days of Zyvox therapy, according to the trial.

Cubists' drug is also being developed as a treatment for complicated skin and soft tissue infections (cSSTI), and it could be approved in the US later this month if the FDA delivers its verdict on the marketing application by the June 20 deadline. An advisory panel to the US regulator voted in favour of approval at the end of March.

Meanwhile in Europe, the marketing application for the antibiotic was recently accepted for review by the European Medicines Agency (EMA) as a therapy for cSSTI.

Cubist acquired tedizolid when it bought Trius Therapeutics' antibiotics portfolio in an $818m deal that closed last year. Analysts have suggested that peak sales of the drug could reach around $750m a year, given the strength in the marketplace of Zyvox and the continuing need for alternatives to generic vancomycin.

Cubist is one of the few pharma companies that is still focusing significant resources on new antibiotics research, and also filed for approval of novel cephalosporin and beta lactamase inhibitor combination CXA-201 (ceftolozane/tazobactam) for complicated urinary tract and  intra-abdominal infections in the US in April.

CXA-201 is also due to be filed in Europe later this year and is in phase III testing for hospital-acquired bacterial pneumonia.

Article by
Phil Taylor

10th June 2014

From: Research

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