- VABOMERE demonstrated a greater numerical overall
success rate vs piperacillin-tazobactam
Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage
company developing and commercializing novel antibiotics to treat
serious bacterial infections, announced today that results from the
Phase 3 TANGO I study of VABOMERE™ (meropenem and vaborbactam)
for injection were published in the Journal of the American Medical
Association (JAMA). VABOMERE was approved by the U.S. Food and Drug
Administration (FDA) in August 2017 for the treatment of adult
patients with complicated urinary tract infections (cUTI),
including pyelonephritis, caused by designated susceptible
Enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae and
Enterobacter cloacae species complex. The Targeting Antibiotic
Non-susceptible Gram-negative Organisms (TANGO I) trial was
the pivotal Phase 3 study that compared the efficacy and safety of
VABOMERE to piperacillin-tazobactam in the treatment of patients
with cUTI and acute pyelonephritis (AP).
Complicated UTIs, including AP, are a major cause of hospital
admissions and are associated with significant morbidity and
mortality. While the most common pathogen in cUTI is Escherichia
coli, the more problematic pathogens are multidrug-resistant (MDR)
gram-negative organisms including other Enterobacteriaceae species
(i.e., Klebsiella pneumoniae). The prevalence of cUTI due to MDR
gram-negative bacteria has risen. If left untreated, MDR
gram-negative bacteria isolated from the urinary tract can cause
bacteremia.
As initially reported in a June 2016 top-line analysis, the
results of TANGO I demonstrated that VABOMERE was non-inferior
to piperacillin-tazobactam with overall success in 98.4% of treated
patients compared with 94.0% following treatment with
piperacillin-tazobactam (p<0.001 for noninferiority) using the
FDA primary endpoint of clinical cure plus microbiological
eradication at the end of IV treatment. The study also met the
European Medicines Association endpoint by demonstrating 66.7%
microbial eradication at the test of cure visit following VABOMERE
treatment compared with 57.7% following piperacillin-tazobactam
treatment (p<0.001 for noninferiority).
In TANGO I, the incidence of adverse events (AEs) and
severe AEs was similar in the VABOMERE and piperacillin-tazobactam
groups. The most frequent AEs (greater than 2%) reported in this
study included headache (8.8% VABOMERE vs 4.4% piperacillin-
tazobactam), diarrhea (3.3% vs 4.4%), vaginal infection (0.4% vs
2.2%), and infusion site phlebitis (2.2% vs 0.7%).
Keith S. Kaye, MD, MPH, professor of internal medicine at the
University of Michigan Medical School at Ann Arbor and director of
research for the Infectious Diseases division at the University of
Michigan, commented, “Complicated UTIs, especially those caused by
CRE, can be extremely difficult to treat due to a lack of effective
therapeutic options. It is therefore essential that products such
as VABOMERE, continue to be developed and brought to market where
they can play an important role in treating these infections.” Dr.
Kaye was the primary investigator of TANGO-I. In addition to his
role at the University of Michigan, he is president of the Society
for Healthcare Epidemiology of America (SHEA).
“Complicated UTIs can be life threatening, with mortality rates
of 20-40% among critically ill patients,” added Dan Wechsler,
Melinta’s president and chief executive officer. “Since our
inception, Melinta has been dedicated to addressing the serious
global health threat of antibiotic resistance. We believe VABOMERE
will play an important role in the treatment of cUTIs, particularly
those caused by KPC-mediated carbapenem resistant
Enterobacteriaceae and is a critical product in our commercial
portfolio.”
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
ContraindicationsVABOMERE 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 ReactionsThe 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 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 and better
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: inability to achieve the expected benefits of the acquisition
of The Medicines Company’s infectious disease business unit;
liquidity and trading market for Melinta’s shares following the
consummation of the acquisition; costs and potential litigation
associated with the acquisition; risks related to the costs, timing
and regulatory review of the Company’s studies and clinical trials;
uncertainties in obtaining successful clinical results for product
candidates and unexpected costs that may result therefrom;
inability or the delay in obtaining required regulatory approvals
for product candidates, which may result in unexpected cost
expenditures; failure to realize any value of certain product
candidates developed and being developed, in light of inherent
risks and difficulties involved in successfully bringing product
candidates to market; inability to develop new product candidates
and support existing products; inability to commercialize and
launch any product candidate that receives regulatory approval,
including Baxdela; risks relating to the Company’s substantial
indebtedness following the consummation of the acquisition and the
Company’s anticipated capital expenditures, its estimates regarding
its capital requirements and its need for future capital;
uncertainties of cash flows and inability to meet working capital
needs; cost reductions that may not result in anticipated level of
cost savings or cost reductions after the consummation of the
acquisition; the approval by the FDA and EMA and any other similar
foreign regulatory authorities of other competing or superior
products brought to market; risks resulting from unforeseen side
effects; risk that the market for the Company’s products may not be
as large as expected; inability to obtain, maintain and enforce
patents and other intellectual property rights or the unexpected
costs associated with such enforcement or litigation; inability to
obtain and maintain commercial manufacturing arrangements with
third party manufacturers or establish commercial scale
manufacturing capabilities; loss of or diminished demand from one
or more key customers or distributors; unexpected cost increases
and pricing pressures; the possibility of economic recession and
its negative impact on customers, vendors or suppliers; and risks
associated with the possible failure to realize certain benefits of
the proposed transactions, including future financial, tax,
accounting treatment, and operating results. 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, 2016, as
amended by Form 10-K/A, filed with the SEC on April 13, 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:Amra Maynard(917)
302-2702Amra.maynard@inventivhealth.com
Investor Inquiries:Lisa DeFrancesco(847)
681-3217ldefrancesco@melinta.com
Raj Mistry(312) 801-2051rmistry@melinta.com
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