Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.
Antibiotics are having a moment...
...and it comes not a moment too soon, as each year, more than 1.2 million people worldwide die from antibiotic-resistant infections. If no action is taken, it’s estimated this number will grow to 10 million per year by 2050.
Public health agencies, scientists and industry groups have been sounding the AMR alarm for years and it hasn’t gone unheard. But despite the collective acknowledgement of the dire need to develop and manufacture new, innovative antibiotics to fight off these so-called ‘superbugs,’ the market dynamics simply aren’t cooperating.
Fortunately, some companies are finding a way. Over the weekend, GSK shared positive results from two phase 3 trials for gepotidacin, an investigational antibiotic for uncomplicated urinary tract infections — bringing the drugmaker a step closer to having the first in a new class of oral antibiotics for the indication in over 20 years.
Gepotidacin is the result of a 2013 public-private partnership between the drugmaker and BARDA. The initial $40 million contract was unique in that it applied broadly to GSK’s portfolio of clinical stage antibacterial assets for treating hospital and biothreat infections — marking the first time BARDA took a portfolio approach to funding drug development. Gepotidacin bested standard-of-care nitrofurantoin in both trials, so it seems the BARDA bucks were well-spent.
In other good news, on Monday an FDA advisory committee to support the approval of Innoviva's intravenous antibiotic for the treatment hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The treatment, sulbactam-durlobactam, combats life-threatening Infections caused by the drug-resistant pathogen, Acinetobacter.
Sulbactam-durlobactam has been designated a ‘qualified infectious disease product’ (QIDP) by the FDA. Passed in 2012, the Generating Antibiotic Incentives Now (GAIN) Act grants a five-year extension to the exclusivity period for antibiotics designated as QIDP with the goal of rewarding innovative companies by giving them more time to recoup development costs.
So this week: Pharma — 2, superbugs — 0.
Merck, Prometheus go steady
Earlier this week, Merck announced it had acquired California-based biotech Prometheus Biosciences in a deal totaling $10.8 billion.
Ahead of patent exclusivity loss for its blockbuster star Keytruda, Merck has been on the search for strategic moves that will allow it to maintain its market position and revenue stream. Prometheus’ lead clinical asset, PRA023, was a driving force behind the acquisition, as the the drug also has blockbuster potential, with Citi analysts predicting it could add 15% to 30% to Merck's long-term earnings once approved.
The mAb is currently under development for the treatment of immune diseases such as ulcerative colitis and Crohn’s disease, the drug works by targeting TNF-like ligand 1A (TL1A), addressing both intestinal inflammation and fibrosis.
Prometheus is a California-based is a biotech is focused on the discovery and development of precision therapeutics and companion diagnostics for patients with inflammatory bowel disease. Founded in 2016, the company developed a proprietary platform called Prometheus360 that uses a combination of diagnostics and machine learning algorithms to identify the specific biological pathways that drive individual patients' IBD.
Last year, rumors of a Seagen, Merck acquisition started circulating, but after the two couldn't agree on a price, Pfizer swooped in and bought Seagen for $43 billion.
As Keytruda's sales keep rising and its patent exclusivity loss date gets closer, we will likely keep seeing Merck making moves to go big and not go home.