FDA Awards Fast Track Status to Tetraphase Pharmaceuticals for IV and Oral Formulations of Eravacycline

WATERTOWN, Mass.--(BUSINESS WIRE)-- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antibiotic candidate, eravacycline. Tetraphase is investigating the safety and efficacy of eravacycline in its ongoing Phase 3 global clinical program; the IGNITE 1 study is evaluating the IV formulation of eravacycline for the treatment of complicated intra-abdominal infections (cIAI); IGNITE 2 is evaluating eravacycline IV-to-oral step-down therapy for the treatment of complicated urinary tract infections (cUTI).

Fast Track designation is awarded to expedite the study and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Eravacycline became eligible for Fast Track status as a result of being designated a Qualified Infectious Disease Product (QIDP); the QIDP designation also makes eravacycline eligible for priority review and an additional five years of U.S. market exclusivity, if approved. These incentives are part of the Generating Antibiotic Incentives Now Act (GAIN Act), which was enacted in July 2012 as part of the FDA Safety and Innovation Act (FDASIA) and was part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).

"We are delighted that eravacycline has received Fast Track designation for both formulations and for both therapeutic indications being pursued," said Guy Macdonald, President and CEO of Tetraphase. "There is a serious and growing public health threat as a result of the rise in increasingly difficult-to-treat bacterial infections, particularly those caused by multidrug-resistant Gram-negative bacteria. With eravacycline and our pipeline of novel antibiotic candidates, we are attempting to directly address this threat. We look forward to working closely with theFDA as we continue to advance eravacycline through Phase 3 development and through the preparation and submission of our NDA filing, which is targeted for the end of 2015."

About IGNITE 1

IGNITE 1 is a randomized, multi-center, double-blind, double-dummy, global Phase 3 clinical trial designed to assess the efficacy and safety of eravacycline, dosed intravenously 1.0 mg/kg every 12 hours, compared with ertapenem, dosed intravenously 1 g every 24 hours, in the treatment of cIAI. The trial is designed to enroll 536 adult patients in approximately 100 centers worldwide and to be a non-inferiority (10% margin) study. The primary endpoint is clinical response at the test-of-cure visit in the microbiological intent-to-treat (micro-ITT) patient population.

About IGNITE 2

IGNITE 2 is a two-part, randomized, multi-center, double-blind, Phase 3 clinical trial designed to assess the efficacy and safety of eravacycline compared with levofloxacin in the treatment of cUTI at approximately 150 clinical trial sites worldwide. The two-part trial features a lead-in portion, in which approximately 120 patients, randomized 1:1:1, will receive eravacycline in one of two IV-to-oral step down dosing cohorts (1.5 mg/kg intravenously every 24 hours followed by 200 mg or 250 mg orally every 12 hours) or levofloxacin (750 mg intravenously every 24 hours followed by 750 mg orally every 24 hours).

Under the planned trial protocol, following treatment of the 120 patients in the lead-in portion of the trial, an evaluation of primary efficacy, safety, and tolerability endpoints will be conducted in a planned interim analysis to determine the dose regimen to be carried forward into the second portion of the trial. An additional 720 patients are expected to then be enrolled and randomized 1:1 to receive the selected dose regimen of eravacycline or levofloxacin. This 720-patient trial is designed to be a non-inferiority (10% margin) study with a primary endpoint of clinical and microbiological response approximately seven days after completion of treatment.

About Tetraphase Pharmaceuticals, Inc.

Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening multidrug-resistant (MDR) bacterial infections, including many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention (CDC). Tetraphase's lead product candidate, eravacycline, is being developed as a broad-spectrum intravenous and oral antibiotic in the IGNITE program (Investigating Gram-negative Infections Treated withEravacycline). Two Phase 3 clinical trials are ongoing: IGNITE 1 for the indication of complicated intra-abdominal infections (cIAI) and IGNITE 2 for complicated urinary tract infections (cUTI). Tetraphase has created more than 3,000 novel tetracycline analogs using its technology platform; in addition to eravacycline, Tetraphase has generated multiple preclinical antibiotic candidates that are currently being evaluated for clinical suitability.

Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "anticipates," "believes," "expects," "plans," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including:whether our cash resources will be sufficient to fund our continuing operations into the first quarter of 2016; whether results obtained in preclinical studies and early clinical trials will be indicative of results obtained in future clinical trials; whether eravacycline will advance through the clinical trial process on a timely basis or at all; whether enrollment for clinical trials will be achieved in the time frame expected; whether submissions will made and approvals will be received from the United States Food and Drug Administration or equivalent foreign regulatory agencies on a timely basis or at all; whether, if eravacycline obtains approval, it will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of our most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 6, 2014. In addition, the forward-looking statements included in this press release represent our views as of April 2, 2014. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.