Tetraphase Pharmaceuticals Announces Everest Medicines’ Submission of an Investigational New Drug Application for Eravacycl...
June 04 2018 - 5:00AM
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical
company focused on developing and commercializing novel antibiotics
to treat life-threatening multidrug-resistant (MDR) infections,
today announced that Everest Medicines Limited (“Everest”), a
C-Bridge Capital-backed biopharmaceutical company based in China
which has the exclusive license to develop and commercialize
eravacycline in China, Taiwan, Hong Kong, Macau, South Korea and
Singapore (the “Territories”), has submitted an Investigational New
Drug (IND) application to China's Food and Drug Administration
(CFDA) for a phase 3 clinical trial of eravacycline in complicated
intra-abdominal infections (cIAI).
“Everest’s IND submission to the CFDA ahead of schedule marks an
important milestone in our strategy to make eravacycline available
as a new antibiotic treatment option for serious, MDR infections,”
said Guy Macdonald, President and CEO of Tetraphase. “We are
delighted with Everest’s rapid progress, which speaks to its
development expertise and our highly collaborative working
relationship, and we look forward to providing future updates as
the process continues.”
As a result of the IND submission, Tetraphase will receive a
milestone payment of $2.5 million. Under the terms of the
agreement, Tetraphase may receive future clinical and regulatory
milestones of up to $14 million as well as sales milestones of up
to $20 million. Tetraphase is also eligible to receive double-digit
tiered royalties on net sales of eravacycline in the Territories.
Everest is solely responsible for the development and
commercialization of eravacycline in the Territories.
Mr. Macdonald added, “This remains an exciting time for
Tetraphase and for the potential of eravacycline in cIAI, with a
New Drug Application under review by the U.S. Food and Drug
Administration and a Marketing Authorization Application under
review by the European Medicines Agency. Now, with Everest’s IND
submitted, we are one step closer to bringing eravacycline to
patients in need on a global level.”
About EravacyclineEravacycline is a novel,
fully-synthetic fluorocycline antibiotic being developed for the
treatment of cIAI and other serious infections, including those
caused by MDR pathogens that have been highlighted as urgent public
health threats by both the World Health Organization and the U.S.
Centers for Disease Control & Prevention (CDC). In clinical
trials, eravacycline has demonstrated potent activity against MDR
pathogens, including carbapenem-resistant Enterobacteriaceae,
Acinetobacter baumannii and colistin-resistant bacteria carrying
the mcr-1 gene.
Eravacycline was investigated for the treatment of cIAI as part
of the Company's IGNITE (Investigating
Gram-negative
Infections Treated with
Eravacycline) phase 3 programs. In IGNITE1, a
pivotal phase 3 trial in patients with cIAI, twice-daily IV
eravacycline met the primary endpoint by demonstrating statistical
non-inferiority of clinical response compared to ertapenem, was
well-tolerated, and achieved high cure rates in patients with
Gram-negative pathogens, including resistant isolates. The IGNITE1
data is serving as the basis of the Marketing Authorization
Application (MAA) for IV eravacycline for the treatment of patients
with cIAI now under review by the European Medicines Agency (EMA).
In IGNITE4, a second phase 3 clinical trial in patients with cIAI,
twice-daily IV eravacycline met the primary endpoint by
demonstrating statistical non-inferiority of clinical response
compared to meropenem, was well-tolerated, and achieved high cure
rates. The Company has used the results from IGNITE1 and IGNITE4 to
support a NDA submission for IV eravacycline in cIAI which is under
review by the FDA with a Prescription Drug User Fee Act (PDUFA)
date of August 28, 2018. To date, in clinical trials, eravacycline
has been administered to over 2,700 patients. Eravacycline has not
been approved for commercial use.
About Tetraphase Pharmaceuticals,
Inc.Tetraphase is a biopharmaceutical company using its
proprietary chemistry technology to create novel antibiotics for
serious and life-threatening bacterial infections, including those
caused by many of the MDR bacteria highlighted as urgent public
health threats by the CDC. The Company has created more than 3,000
novel tetracycline compounds using its proprietary technology
platform. Tetraphase's pipeline includes three antibiotic clinical
candidates: eravacycline, which has completed phase 3 clinical
trials and is under review for potential approval in cIAI by the
FDA and the EMA, and TP-271 and TP-6076, which are in phase 1
clinical trials. Please visit www.tphase.com for more Company
information.
Forward-Looking StatementsAny 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 the Company's regulatory
submission will receive approval from the United States Food and
Drug Administration or equivalent foreign regulatory agencies;
whether, if any clinical candidate, including eravacycline, obtains
approval, it will be successfully distributed and marketed; and
other factors discussed in the "Risk Factors" section of our
quarterly report on Form 10-Q for the period ended March 31,
2018, filed with the Securities and Exchange Commission on May 3,
2018. In addition, the forward-looking statements included in this
press release represent our views as of June 4, 2018. 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.
Media and Investor Contact:Jennifer
Vierajviera@tphase.com617-600-7040
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