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Tetraphase plots Q4 launch for first antibiotic after long-awaited OK for eravacycline

It took a few years more than expected, but Tetraphase finally has a product to sell.

Late Monday, the biotech announced that the FDA has approved their lead antibiotic, eravacycline, for complicated intra-abdominal infections (cIAI). The company expects to launch the intravenous drug as Xerava in the US by the end of the year.

Guy Macdonald

The news comes four years after Tetraphase first posted positive Phase III data for the drug in this indication, back when the company thought the antibiotic could also treat complicated urinary tract infections (cUTI). As eravacycline flopped the late-stage study for cUTI, regulators sent the company’s first NDA back demanding a second set of results.

While the follow-up cUTI study ultimately proved to be equally disappointing — hammering the stock $TTPH and destroying the program’s future — Tetraphase managed to build a new case around a promising Phase III that, when combined with the first study, showed eravacycline was non-inferior to the widely used generic antibiotics ertapenem and meropenem.

With a final decision from European regulators coming up, commercialization is now at the top of mind.

“We are thrilled to have received FDA approval, and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe all within the same quarter,” said CEO Guy Macdonald in a statement. “We will now turn our efforts towards delivering Xerava to patients suffering from cIAI in the United States, an important goal we expect to begin executing on in the fourth quarter of this year.”

While the list price will be finalized over the next few weeks, Macdonald tells me it will fall within the range of $175 to $250 per day — distinguishing the drug from some recently approved antibiotics, like Achaogen’s Zemdri, which are intended to be used “basically where nothing else works.”

“We clearly want to penetrate the first and second line market and get the drug used much earlier,” he said. “Our label supports that, and the pricing strategy we pick as well.”

The focus on complicated patients in hospitals, he adds, means their sales team can be concentrated in their efforts. So far, Tetraphase has built out a team of about 50, with 35 of those being regional sales reps.

With Big Pharma bowing out of the antibiotics field one by one — Novartis being the latest to join the exodus — the tall charge of developing new weapons for the battle against growing antibiotic resistance has largely fallen on smaller biotechs. Tetraphase’s technology, licensed from Harvard, promises to improve upon the tetracycline class of antibiotics, making them powerful enough to overcome multidrug resistance.

Philip Barie, a professor of surgery and public health at Weill Cornell Medicine, put it this way:

Complicated intra-abdominal infections are the second-most prevalent infection site in intensive care units (ICUs), as well as the second leading cause of infection-related mortality in ICUs. With the growing crisis of antibiotic resistance, treatment options for these polymicrobial infections are limited following surgery or percutaneous drainage, and the causative pathogens may be multi-drug resistant. Current empiric treatments for cIAI have limitations, and there is a need for new and novel treatments. Eravacycline has a broad spectrum of antibacterial activity and a clinical profile that addresses this unmet medical need.

Tetraphase shares steadily rose leading up to the announcement about the approval, and has taken a 11% plunge since the news hit.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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