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 $8
Million
Larry Edwards Named President and Chief
Executive Officer; Guy Macdonald to Remain on Board of
Directors
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), (“Tetraphase” or
“the Company”) today announced a corporate reorganization in order
to maximize the commercial opportunity for XERAVA™ (eravacycline),
the Company’s novel tetracycline antibacterial indicated for the
treatment of complicated intra-abdominal infections (cIAI) in
patients 18 years of age and older. This reorganization 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. Mr.
Edwards will join the Tetraphase Board of Directors (“the Board”)
in August, and Mr. Macdonald will remain a director and, in
addition, serve as a consultant to the Company into December
2019.
“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, 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
reorganization 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 reorganization and
other cost-saving efforts will result in an approximate $8.2
million reduction in net cash required for operating activities on
an annualized basis. Tetraphase estimates that the reorganization
will be substantially completed by the third quarter of 2019 and
that the Company will incur approximately $2.4 million of pre-tax
charges for severance and other costs, primarily during the second
and third quarters of 2019.
About XERAVA™
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.
To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase
Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for XERAVA at
www.XERAVA.com.
About Tetraphase Pharmaceuticals, Inc.
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 U.S. Food and Drug
Administration and the European Medicines Agency. Please visit
www.tphase.com for more company information.
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,
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 ended March 31, 2019, filed with
the Securities and Exchange Commission on May 8, 2019. In addition,
the forward-looking statements included in this press release
represent our views as of June 12, 2019. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190612005827/en/
Investor and Media Contact:Argot PartnersMaeve
Conneighton212-600-1902maeve@argotpartners.com
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