Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage
company discovering, developing and commercializing novel
antibiotics to treat serious bacterial infections, today announced
that the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) has adopted a positive opinion
recommending Vabomere™ (meropenem and vaborbactam) for approval as
a treatment for adult patients with complicated intra-abdominal
(cIAI) and urinary tract infections (cUTI), hospital-acquired
pneumonia including ventilator associated pneumonia (HAP/VAP),
bacteraemia that occurs in association with any of these
infections, and infections due to aerobic Gram-negative organisms
where treatment options are limited.
The CHMP’s opinion will be reviewed by the European Commission
(EC), which is expected to make a final decision regarding
marketing authorization within 67 days of receiving the CHMP
opinion. If approved by the EC, marketing authorization for
Vabomere will be granted in all 28 countries of the European Union,
Norway, Iceland and Liechtenstein. Milestone payment obligations
related to Vabomere’s European approval would not take effect until
marketing authorization is granted by the EC.
“We are encouraged by the CHMP’s positive recommendation for
Vabomere, which brings us one step closer to providing access to
this important treatment option for patients in Europe,” said Dan
Wechsler, President and CEO of Melinta. “Additionally, we were
pleased to see the range of indications recommended for approval,
underscoring our belief that Vabomere represents a significant new
advancement in addressing the increasing incidence of KPC-producing
Enterobacteriaceae, for which there are currently limited treatment
options.”
The CHMP opinion was supported by data from the TANGO clinical
program, including data from TANGO-1, a Phase III, multi-center,
randomized, double-blind, double-dummy study to evaluate the
efficacy, safety and tolerability of Vabomere compared to
piperacillin-tazobactam in the treatment of cUTI, including acute
pyelonephritis, in adults, as well as TANGO-2, a multi-center,
randomized, open-label clinical trial of Vabomere versus “best
available therapy” in subjects with known or suspected
carbapenem-resistant Enterobacteriaceae (CRE).
Vabomere was approved by the U.S. Food and Drug Administration
(FDA) in August 2017 for the treatment of adult patients
who have been diagnosed with complicated urinary tract infections
(cUTIs), including pyelonephritis, caused by treatment of adult
patients caused by designated susceptible Enterobacteriaceae
– Escherichia coli, Klebsiella
pneumoniae and Enterobacter cloacae species complex.
Vabomere is a drug containing meropenem, an antibacterial, and
vaborbactam, which is a new class of beta-lactamase inhibitor that
inhibits certain types of resistance mechanisms used by
bacteria.
About VABOMERE™ (meropenem and vaborbactam) for
Injection
VABOMERE (meropenem and vaborbactam) is indicated for the
treatment of patients 18 years of age and older with complicated
urinary tract infections (cUTI) including pyelonephritis caused by
the following susceptible microorganisms: Escherichia coli,
Klebsiella pneumoniae, and Enterobacter cloacae species
complex.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of VABOMERE and other antibacterial
drugs, VABOMERE should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
Contraindications
VABOMERE is contraindicated in patients with known
hypersensitivity to any components of VABOMERE (meropenem and
vaborbactam), or to other drugs in the same class or in patients
who have demonstrated anaphylactic reactions to beta-lactam
antibacterial drugs.
Warnings and Precautions
Hypersensitivity reactions were reported in patients treated
with VABOMERE in the clinical trials. Serious and occasionally
fatal hypersensitivity (anaphylactic) reactions and serious skin
reactions have been reported in patients receiving therapy with
beta-lactam antibacterial drugs. There have been reports of
individuals with a history of penicillin hypersensitivity who have
experienced severe hypersensitivity reactions when treated with
another beta-lactam antibacterial drug. If an allergic reaction to
VABOMERE occurs, discontinue the drug immediately.
Seizures and other adverse Central Nervous System (CNS)
experiences have been reported during treatment with meropenem,
which is a component of VABOMERE. Close adherence to the
recommended dosage regimens is urged, especially in patients with
known factors that predispose to convulsive activity.
Clostridium difficile-associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents, including
VABOMERE, and may range in severity from mild diarrhea to fatal
colitis. Careful medical history is necessary since CDAD has been
reported to occur over two months after the administration of
antibacterial agents. If CDAD is suspected or confirmed, ongoing
antibacterial drug use not directed against C. difficile may need
to be discontinued.
The concomitant use of VABOMERE and valproic acid or divalproex
sodium is generally not recommended. Case reports in the literature
have shown that co-administration of carbapenems, including
meropenem, to patients receiving valproic acid or divalproex sodium
results in a reduction in valproic acid concentrations. The
valproic acid concentrations may drop below the therapeutic range
as a result of this interaction, therefore increasing the risk of
breakthrough seizures. If administration of VABOMERE is necessary,
consider supplemental anticonvulsant therapy.
In patients with renal impairment, thrombocytopenia has been
observed in patients treated with meropenem, but no clinical
bleeding has been reported.
Alert patients receiving VABOMERE on an outpatient basis
regarding adverse reactions such as seizures, delirium, headaches
and/or paresthesias that could interfere with mental alertness
and/or cause motor impairment.
Prescribing VABOMERE in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of drug-resistant bacteria.
As with other antibacterial drugs, prolonged use of VABOMERE may
result in overgrowth of non-susceptible organisms.
Adverse Reactions
The most frequently reported adverse reactions occurring in ≥3%
of patients treated with VABOMERE were headache, phlebitis/infusion
site reactions, and diarrhea.
Please see www.VABOMERE.com for the full FDA-approved
prescribing information.
About Melinta Therapeutics Melinta
Therapeutics, Inc. is the largest pure-play antibiotics company,
dedicated to saving lives threatened by the global public health
crisis of bacterial infections through the development and
commercialization of novel antibiotics that provide new therapeutic
solutions. Its four marketed products include Baxdela™
(delafloxacin), Vabomere™ (meropenem and vaborbactam), Orbactiv®
(oritavancin), and Minocin® (minocycline) for Injection. It also
has an extensive pipeline of preclinical and clinical-stage
products representing many important classes of antibiotics, each
targeted at a different segment of the anti-infective market.
Together, this portfolio provides Melinta with the unique ability
to provide providers and patients with a range of solutions that
can meet the tremendous need for novel antibiotics treating serious
infections. Visit www.melinta.com for more information.
Cautionary Note Regarding Forward-Looking
Statements Certain statements in this communication
constitute “forward-looking statements” within the meaning of
Section 27A of the Securities Act and Section 21E of the Securities
Exchange Act and are usually identified by the use of words such as
“anticipates,” “believes,” “estimates,” “expects,” “intends,”
“may,” “plans,” “projects,” “seeks,” “should,” “will,” and
variations of such words or similar expressions. We intend these
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act and Section 21E of the Securities Exchange
Act and are making this statement for purposes of complying with
those safe harbor provisions. These forward-looking statements
reflect our current views about our plans, intentions,
expectations, strategies and prospects, which are based on the
information currently available to us and on assumptions we have
made. Although we believe that our plans, intentions, expectations,
strategies and prospects as reflected in or suggested by those
forward-looking statements are reasonable, we can give no assurance
that the plans, intentions, expectations or strategies will be
attained or achieved. Furthermore, actual results may differ
materially from those described in the forward-looking statements
and will be affected by a variety of risks and factors that are
beyond our control.
Risks and uncertainties for Melinta include, but are not limited
to: the fact that we have incurred significant operating losses
since inception and will incur continued losses for the foreseeable
future; our limited operating history; our need for future capital
and risks related to our ability to obtain additional capital to
fund future operations; uncertainties of cash flows and inability
to meet working capital needs as well as other milestone, royalty
and payment obligations; the fact that our independent registered
public accounting firm’s report on the Company’s 2016 and 2017
financial statements contains an explanatory paragraph that states
that the our recurring losses from operations and our need to
obtain additional capital raises substantial doubt about our
ability to continue as a going concern; our substantial
indebtedness; risks related to our commercial launches of our
products and our inexperience as a company in marketing drug
products; the degree of market acceptance of our products among
physicians, patients, health care payors and the medical community;
the pricing we are able to achieve for our products; failure to
obtain and sustain an adequate level of reimbursement for our
products by third-party payors; inaccuracies in our estimates of
the market for and commercialization potential of our products;
failure to maintain optimal inventory levels to meet commercial
demand for any of our products; risks that our competitors are able
to develop and market products that are preferred over our
products; our dependence upon third parties for the manufacture and
supply of our marketed products; failure to achieve the benefits of
our recently completed transactions with Cempra and The Medicines
Company; failure to establish and maintain development and
commercialization collaborations; uncertainty in the outcome or
timing of clinical trials and/or receipt of regulatory approvals
for our product candidates; undesirable side effects of our
products; failure of third parties to conduct clinical trials in
accordance with their contractual obligations; our ability to
identify, develop, acquire or in-license products; difficulties in
managing the growth of our company; the effects of recent
comprehensive tax reform; risks related to failure to comply with
extensive laws and regulations; product liability risks related to
our products; failure to retain key personnel; inability to obtain,
maintain and enforce patents and other intellectual property rights
or the unexpected costs associated with such enforcement or
litigation; risks relating to third party infringement of
intellectual property rights; our ability to maintain
effective internal control over financial reporting; unfavorable
outcomes in any of the class action and shareholder derivative
lawsuits currently pending against the Company; and the fact that a
substantial amount of shares of common stock may be sold into the
public markets by one or more of our large shareholders in the near
future. Many of these factors that will determine actual
results are beyond Melinta’s ability to control or predict.
Other risks and uncertainties are more fully described in our
Annual Report on Form 10-K for the year ended December 31, 2017,
and in other filings that Melinta makes and will make with the SEC.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. The statements made in this press release speak
only as of the date stated herein, and subsequent events and
developments may cause our expectations and beliefs to change.
While we may elect to update these forward-looking statements
publicly at some point in the future, we specifically disclaim any
obligation to do so, whether as a result of new information, future
events or otherwise, except as required by law. These
forward-looking statements should not be relied upon as
representing our views as of any date after the date stated
herein.
For More Information:
Media Inquiries:David Belian(203) 848-6276
Investor Inquiries:Lisa DeFrancesco(908) 617-1358
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