Therapy Areas: Oncology
Tetraphase Pharmaceuticals Launches Corporate Reorganisation
17 June 2019 - - US-based Tetraphase Pharmaceuticals, Inc. (NASDAQ: TTPH) has launched a corporate reorganisation in order to maximise the commercial opportunity for Xerava (eravacycline), the company's novel tetracycline antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older, the company said.
This reorganisation will include elimination of the company's internal research function and an exploration of out-licensing opportunities for the company's pipeline of innovative early-stage antibiotics and oncology product candidates.
As part of the reorganization, Larry Edwards, who currently serves as chief operating officer, will succeed Guy Macdonald as president and chief executive officer following a transition period that will last through August 1, 2019.
Edwards will join the Tetraphase board of directors in August, and Macdonald will remain a director and, in addition, serve as a consultant to the company into December 2019.
In addition to the promotion of Edwards, Maria Stahl, senior vice president and General Counsel of Tetraphase, has been promoted to Chief Business officer.
In this new role, her responsibilities will include overseeing other corporate functions, including finance, business development and investor relations.
The reorganisation will also include the departure of Tetraphase's Chief Medical officer, Larry Tsai, M.D. and chief scientific officer, Jacques Dumas, Ph.D. Dr. Tsai has been an outstanding contributor to Tetraphase's development programs. Dr. Tsai is resigning his position effective June 24, 2019.
Dr. Dumas' position is being eliminated effective July 19, 2019. Dr. Dumas is expected to enter into a consulting relationship with the company in order to support the out licensing of TP-2846, the company's novel drug candidate for acute myeloid leukemia. Dr. Dumas leadership was critical in the development effort leading to TP-2846.
Elimination of the company's research function and certain corporate support functions will result in a reduction in force of approximately 20%, or 24 employees.
The company expects that the reorganisation and other cost-saving efforts will result in an approximate USD8.2 m reduction in net cash required for operating activities on an annualized basis.
Tetraphase estimates that the reorganisation will be substantially completed by 3Q19 and that the company will incur approximately USD 2.4m of pre-tax charges for severance and other costs, primarily during 2Q19 and 3Q19.
Xerava (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections 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 programme.
In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous 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.
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 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, nausea, and vomiting.
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.
Tetraphase Pharmaceuticals, Inc., is a biopharmaceutical company using its proprietary chemistry technology to create novel tetracyclines for serious and life-threatening conditions, including infections caused by many of the multidrug-resistant bacteria highlighted as urgent public health threats by the World Health Organization and the Centers for Disease Control and Prevention.
The company has created more than 3,000 novel tetracycline compounds using its proprietary technology platform. Tetraphase's lead product Xerava is approved for the treatment of complicated intra-abdominal infections by the US Food and Drug Administration and the European Medicines Agency.
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