Merck tests antibiotics waters again as FDA OKs Zerbaxa's expanded use in pneumonia
In a rare Big Pharma advance in the antibiotics field, Merck has revived hopes for Zerbaxa with a new approval for two types of pneumonia commonly observed in hospitals.
The drug — which consists of ceftolozane and tazobactam — has garnered meager sales since it was first approved in 2014 for complicated urinary tract infections, not even enough to warrant a mention in Merck’s annual report last year.
Back when Merck bought out Cubist for $9.5 billion, Zerbaxa was a bright late-stage prospect tapped for peak sales in the lofty blockbuster range of $1.2 billion to $1.5 billion or so.
With the expanded label, the pharma giant could start inching toward that goal. Joan Butterton, associate vice president in infectious disease clinical research at Merck, told FiercePharma the new indication is “really what Zerbaxa was designed to do.”
“Pneumonia in ventilated patients remains a significant clinical challenge and is associated with substantial morbidity and mortality,” said Andrew Shorr, head of pulmonary, critical care and respiratory services, Medstar Washington Hospital Center, added in a statement. “The need to cover diverse pathogens including Pseudomonas aeruginosa and certain Enterobacteriaceae adds to the challenge.”
Last September, Merck reported that Zerbaxa scored in a late-stage non-inferiority showdown with meropenem for either ventilated hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia.
While JP Morgan analysts have forecast sales of more than $450 million, Baird’s Brian Skorney was quick to point out Vibativ, OK’d for both indications, does $20 million a year. Theravance sold the antibiotic to Cumberland Pharma months ago.
Merck, though, is slogging along as one of the last Big Pharma working on new antibiotics together with Roche and GlaxoSmithKline — keeping a small early-stage discovery team after axing Cubist’s group. Its submission for a combo of relebactam, imipenem and cilastatin to treat complicated urinary tract infections (cUTI) and complicated intra-abdominal infections is under review at the FDA.