Merck is bucking the trend of its biopharma peers by continuing to invest in and build its infectious disease pipeline. With new regulatory pathways in play and novel funding mechanisms for antibiotics starting to take off, the pharma believes its decision to stay the course will be rewarded.
Merck has a long history in infectious diseases and antimicrobials, including developing one of the first methods of mass producing penicillin in 1942.
But many other pharmas have abandoned the space given the length and expense of developing novel antibiotics and their uncertain commercial prospects if they make it to the market.
“We are only one of the few remaining companies that works in the clinic at both an early and a late stage, even doing large trials for expanding indications, showing our interest across the entire space,” said Joan Butterton, associate VP and section head for antibacterial and cytomegalovirus at Merck Research Laboratories.
In June, the pharma received approval for an sBLA of its Zerbaxa ceftolozane/tazobactam to treat adults with hospital-acquired and ventilator-acquired bacterial pneumonia (HABP/VABP).
It also has two NMEs under FDA review -- relebactam has a July 16 PDUFA date for treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), and