Less than a year after Cubist ($CBST) scooped up Trius for $707 million in a bid to boost its presence in antibiotics, it can boast an FDA approval out of the deal. On Friday, the agency approved Sivextro, an antibacterial drug to treat a range of skin infections, including methicillin-resistant Staphylococcus aureus (MRSA).
Sivextro (tedizolid phosphate) can be administered orally or intravenously and will be a direct competitor to Pfizer's ($PFE) Zyvox, a widely used antibiotic that brought in $1.4 billion in sales last year. In late-stage trials, Sivextro proved as effective as Zyvox, but with fewer side effects, less frequent dosing, and a shorter treatment time. That could help it compete with upcoming generic versions of Zyvox, which loses its patent protection next year.Ralph Corey
Ralph Corey, a professor of medicine and infectious disease at Duke University Medical Center, said in a Cubist press release that when it comes to drug-resistant infections, the more choices the better. "MRSA is still problematic in the U.S. and is responsible for the deaths of more than 11,000 Americans each year," Corey said. "A 6-day course of therapy with the option to choose--and, if needed--change from I.V. to oral administration is a welcome new development."
Cubist made its name in antibiotics on the strength of one product, Cubicin, but the company has been making some major investments in antibiotics R&D. On the same day the company bought Trius, it also picked up Optimer Pharmaceuticals for $535 million. That deal gave Cubist control over Dificid, Optimer's antibiotic to fight Clostridium difficile.
And Cubist has vowed to spend $400 million in R&D this year alone to fund its goal of delivering four new antibiotics by 2020. Sivextro is first in line, followed closely by ceftolozane/tazobactam, an antibiotic to treat complicated urinary tract and intra-abdominal infections; the FDA is expected to decide that drug's fate in late December. Cubist's pipeline includes more drugs to fight C. diff, as well as hospital-acquired bacterial pneumonia candidates.