– Approved for adult patients with acute
bacterial skin and skin structure infections (ABSSSI) –
Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage
company developing and commercializing novel antibiotics to treat
serious bacterial infections, today announced the U.S. launch of
intravenous and oral formulations of Baxdela™ (delafloxacin)
for the treatment of adult patients with acute bacterial skin and
skin structure infections (ABSSSI) caused by designated susceptible
bacteria. With Baxdela, no dosage adjustments are required due to
weight, hepatic impairment or mild-moderate renal impairment, there
are no food effects, and there is minimal potential for drug
interactions.
“Today’s launch of Baxdela is a significant milestone for
Melinta – one that comes on the heels of a very successful year,
cementing our leadership position in the antibiotics space,” stated
Dan Wechsler, president & chief executive officer of Melinta.
“I would especially like to thank the doctors and patients around
the world that participated in our Baxdela clinical trial program,
as well as the Melinta team that has worked tirelessly over many
years to bring Baxdela to the market. It is because of their
dedication that we are able to offer patients and healthcare
providers this new treatment option.”
Approximately 14 million patients are treated for serious skin
infections each year, either in the hospital or community settings,
and these are often caused by MRSA.
“We believe that Baxdela will be an important treatment option
for providers treating serious skin infections in both the hospital
and community settings,” commented Mike McGuire, Melinta’s senior
vice president, Commercial. “These patients often present treatment
challenges owing to their underlying medical conditions (e.g.,
comorbidities such as obesity and diabetes), which can make optimal
antibiotic selection difficult. The launch has the support of an
experienced sales team and is further enhanced by the availability
of three antimicrobial susceptibility tests that offer providers a
full set of clinical tools to determine how to treat patients
appropriately.”
Melinta will market Baxdela nationwide leveraging an
industry-leading commercial sales team. Baxdela joins a strong
portfolio of infectious disease products that will be marketed by
Melinta, including Vabomere™ (meropenem and vaborbactam), Orbactiv®
(oritavancin) and Minocin® (minocycline) for injection.
“Baxdela’s performance in clinical trials of skin infections
demonstrated a good clinical efficacy profile and was
well-tolerated,” said James A. McKinnell, MD, assistant professor
of medicine, David Geffen School of Medicine, University of
California, Los Angeles. “Microbiologic activity and clinical
effectiveness against MRSA make Baxdela a novel fluoroquinolone
with potential for treating certain skin infections.”
About Baxdela
Baxdela (delafloxacin) tablets and intravenous injection are
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of ABSSSI (Acute Bacterial Skin and Skin Structure
Infections). Baxdela was approved by the FDA in 2017 based on its
efficacy against both gram-positive and gram-negative pathogens,
including MRSA. It was given priority review by the FDA due to its
designation as a Qualified Infectious Disease Product (QIDP) under
the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The
QIDP designation qualifies Baxdela for certain incentives related
to the development of new antibiotics, including a five-year
extension of any non-patent exclusivity period awarded to the drug.
For more information, please visit http://www.baxdela.com/ or call
1-844-Melinta.
INDICATION & USAGE
Baxdela is indicated in adults for the treatment of acute
bacterial skin and skin structure infections (ABSSSI) caused by
susceptible isolates of the following:
Gram-positive organisms: Staphylococcus aureus (including
methicillin-resistant [MRSA] and methicillin-susceptible [MSSA]
isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis,
Streptococcus agalactiae, Streptococcus anginosus group (including
Streptococcus anginosus, Streptococcus intermedius, and
Streptococcus constellatus), Streptococcus pyogenes, and
Enterococcus faecalis;
Gram-negative organisms: Escherichia coli, Enterobacter cloacae,
Klebsiella pneumoniae, and Pseudomonas aeruginosa.
IMPORTANT SAFETY INFORMATION:WARNING:
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE,
PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, AND
EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones have been associated with disabling and
potentially irreversible serious adverse reactions that have
occurred together, including:
- Tendinitis and tendon rupture
- Peripheral neuropathy
- Central nervous system effects
Discontinue Baxdela
immediately and avoid the use of fluoroquinolones,
including Baxdela, in patients
who experience any of these serious adverse reactions.
Fluoroquinolones may exacerbate muscle weakness in
patients with myasthenia gravis. Avoid Baxdela in patients with
known history of myasthenia gravis.
ContraindicationsBaxdela is contraindicated in
patients with known hypersensitivity to Baxdela or other
fluoroquinolones.
Warnings and PrecautionsRisk of tendinitis,
tendon rupture, peripheral neuropathy and central nervous system
effects is increased with use of fluoroquinolones. Discontinue
Baxdela immediately at the first signs or symptoms of any of these
serious adverse reactions.
Avoid Baxdela in patients with known history of myasthenia
gravis.
Hypersensitivity Reactions may occur after first or subsequent
doses of Baxdela. Discontinue Baxdela at the first sign of
hypersensitivity.
Clostridium difficile-associated diarrhea has been reported in
users of nearly all systemic antibacterial drugs, including
Baxdela. Evaluate if diarrhea occurs.
Prescribing Baxdela in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
Adverse ReactionsThe most common adverse
reactions in patients treated with Baxdela were nausea (8%),
diarrhea (8%), headache (3%), transaminase elevations (3%), and
vomiting (2%).
Use in Specific PopulationsIn patients with
severe renal impairment (eGFR of 15-29 mL/min/1.73 m2) dosing of
Baxdela should be dosed at 200 mg IV every 12 hours or 450 mg
orally every 12 hours. Baxdela is not recommended in patients with
End Stage Renal Disease [ESRD] (eGFR of <15 mL/min/1.73 m2) due
to insufficient information to provide dosing recommendations.
A FDA-approved patient labeling guide (Medication Guide) is
available for patients taking Baxdela.
Please also see full Prescribing Information, including Boxed
Warning, available at www.baxdela.com.
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(212) 845-5625 / (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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