Company to Eliminate Internal Research Function and Explore Pipeline Out-licensing Opportunities to Focus the Company’s Resources on XERAVA™ Commercial Success
Workforce and R&D Expense Reduction Expected to Result in Annualized
Savings of Approximately
Larry Edwards Named President and Chief Executive Officer;
“XERAVA is a critically important new addition to the hospital antibiotic armamentarium, and we firmly believe that by implementing this reorganization we can concentrate our efforts and resources entirely on ensuring its commercial success,” said Mr. Macdonald. “Despite the urgent public health crisis stemming from a need for newer, more effective antibiotics, the process of launching one requires a long runway and unwavering perseverance. The Board and I believe that Larry, with his extensive experience launching novel antibiotics, is the right person to lead Tetraphase through the XERAVA launch period, and that a singularly focused organization is central to the success of our mission.”
“The changes we are undertaking are intended to enable Tetraphase to focus all of its resources on the commercial success of XERAVA, and I am honored to lead this effort going forward,” said Mr. Edwards. “As a result of the efforts of our field force, we are seeing a strong uptake for XERAVA in the US, where we continue to see double digit monthly growth in sales of cartons with a mean growth of 40% per month over the last three months. Currently, in the second quarter of 2019 we are tracking to double our net sales as compared to the first quarter and continuing to observe increased formulary uptake. Tetraphase owes its many innovations, including the discovery of XERAVA, TP-271, TP-6076 and TP-2846, to its foundational chemistry platform, making the decision to eliminate our research group particularly difficult. We look forward to exploring opportunities for additional value creation through the out-licensing of our innovative early-stage antibiotics and oncology portfolio. We wish the best for those affected by this reorganization and will endeavor to make their transitions to other opportunities as smooth as possible.”
In addition to the promotion of Mr. Edwards,
XERAVA(eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) 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, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.
Important Safety Information
XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.
The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).
XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.
Please see full Prescribing Information for XERAVA at www.XERAVA.com.
Any statements in this press release about our future expectations,
plans and prospects, including statements regarding our strategy, future
operations, prospects, plans and objectives, including the anticipated
benefits of the restructuring, 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 our cash
resources and the expected revenue from sales of XERAVA will be
sufficient to fund our operations in the future; whether the
restructuring and the focus on our commercial operations will result in
the reduced expenses and other benefits that we anticipate; and other
clinical, regulatory and commercial risk factors discussed in the "Risk
Factors" section of our quarterly report on Form 10-Q for the period
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