Tetraphase Prepares for US Launch of Xerava

Health and Healthcare

Published: October 12, 2018 11:25 am

Last Updated: January 11, 2020 4:29 pm

Tetraphase Pharmaceuticals Inc. (NASDAQ: TTPH) shares were up handily on Friday after the company announced the U.S. commercial launch of Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI).

The wholesale acquisition cost of Xerava will be $175 per day of therapy to support the company’s strategy of having Xerava used for the empiric treatment of cIAI.

Xerava was investigated for the treatment of cIAI as part of the company’s IGNITE Phase 3 program. In these two late-stage trials, Xerava achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

In the first pivotal Phase 3 trial in patients with cIAI, Xerava met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well tolerated. In the second Phase 3 clinical trial in patients with cIAI, Xerava met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well tolerated.

Guy Macdonald, president and CEO of Tetraphase, commented:

The launch of XERAVA marks an important milestone for Tetraphase and for physicians with patients in need of a new broad-spectrum antibiotic for serious, often life-threatening, multidrug-resistant infections. This important achievement marks the culmination of many years of dedication and follows the regulatory approvals of XERAVA both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency.

Shares of Tetraphase were up about 2.5% at $2.45 on Friday, with a consensus analyst price target of $7.00 and a 52-week trading range of $2.05 to $7.29.