Just as Big Pharmas are bailing out of antibiotics research left and right, a small biotech is pressing ahead with a new drug approval. Tetraphase Pharmaceuticals snagged an FDA nod for Xerava, an infection-fighter engineered to overcome drug resistance.
Tetraphase's first approved drug, Xerava won its green light to treat complicated intra-abdominal infections (cIAI). The company is aiming for a fourth-quarter launch at a price range of $175-$250 per day, which it hopes can vault Xerava onto formularies quickly, COO Larry Edwards said during a briefing Monday.
The broad-spectrum antibiotic belongs to the well-established tetracycline family, but Tetraphase used synthetic technology pioneered at Harvard University to create a more potent candidate to overcome resistant pathogens. In two phase 3 studies, the drug matched up to two widely prescribed carbapenems: Merck & Co.’s Invanz (ertapenem) and Pfizer’s Merrem (meropenem).
Carbapenems have been on the market for decades, and the FDA just last year approved a new member in Melinta’s Vabomere. But increased use has led to increased resistance, Tetraphase CMO Larry Tsai said on the call.
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Tetraphase executives said Xerava boasts two advantages over existing antibiotics. First, its label allows it to be used even if the pathogen causing the infection hasn't yet been identified. Xerava has demonstrated in vitro activity against many multidrug-resistant germs, including E. coli carrying the mcr-1 gene, a resistant type that emerged in U.S. patients in 2016. Plus, Xerava doses don't need to be adjusted in patients whose kidneys are impaired. Renal function can be highly changeable in critically ill patients, Tsai noted.
Complicated intra-abdominal infections now require some 40 million days of therapy each year in the U.S. and Europe, Tetraphase said, and the company believes Xerava can capture 2 million days' worth.
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Xerava is on the verge of a final European approval, having been recommended by the Committee for Medicinal Products for Human Use (CHMP) last month. Through a deal inked in February, Tetraphase licensed its rights in China, South Korea and Singapore to Everest Medicines.
Despite increasing antibiotic resistance, Big Pharmas have bailed out of the antibacterial realm one after another. The market for new antibiotics is limited, or so the thinking goes, because new anti-infectives are often saved for last-line use.
Novartis just last month announced it is shutting down research in the field and put its current projects up for sale, including its lead product, LYS228, now in phase 2 for cIAI and complicated urinary tract infections. Allergan in May put its “non-core” infectious disease unit, along with its women’s health business, on the block. AstraZeneca, Roche, Bristol-Myers Squibb and Eli Lilly each have taken similar measures.