Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage
company developing and commercializing novel antibiotics to treat
serious bacterial infections, today announced that the European
Commission (EC) has approved Vabomere® (meropenem and vaborbactam)
for use in 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. Marketing authorization was granted in all 28
European Union (EU) member states, as well as Norway, Iceland and
Liechtenstein.
“Few effective treatment options and increasing resistance have
made KPC-producing Enterobacteriaceae a significant challenge to
patients worldwide,” said John H. Johnson, Interim CEO and Director
of Melinta. “With the EC authorization of Vabomere, we believe
Melinta, through its strong partnership with Menarini Group, will
be able to make a significant impact on the European effort to
address this life-threatening pathogen."
The EC approval follows a positive opinion issued by the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) in September 2018, that was based
in part on data from the TANGO clinical program.
TANGO-1, a Phase III, multi-center, randomized, double-blind,
double-dummy study, evaluated the efficacy, safety and tolerability
of Vabomere compared to piperacillin-tazobactam in the treatment of
adults with cUTI, including acute pyelonephritis. TANGO-2, a
multi-center, randomized, open-label clinical trial, assessed
VABOMERE versus “best available therapy” in adults with known or
suspected carbapenem-resistant Enterobacteriaceae (CRE).
About VABOMERE® (meropenem and vaborbactam) for
InjectionIn the United States, 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 US
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. 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, strategies or prospects
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; risks related to the satisfaction of the
closing conditions under the Vatera equity commitment letter, to
the extent drawn by the Company, including receipt of stockholder
approval; 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 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; and the other risks referenced in the paragraph below.
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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