Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage
company developing and commercializing novel antibiotics to treat
serious bacterial infections, today announced that Eurofarma
Laboratórios has submitted a marketing authorization application
for delafloxacin (marketed under the trade name Baxdela™ in the
U.S.) in Argentina with the Ministry of Health's National
Administration of Drugs, Foods and Medical Technology (ANMAT).
Eurofarma Laboratórios is Melinta’s commercialization and
distribution partner for all countries in South and Central America
and the Caribbean, including Argentina. The proposed indication for
delafloxacin in Argentina is for the treatment of adult patients
with acute bacterial skin and skin structure infections (ABSSSI).
“In Latin America, as in much of the world, the rising rates of
resistance in pathogens responsible for serious skin infections is
a growing health concern,” stated Dan Wechsler, Melinta’s president
and chief executive officer. “Delafloxacin offers physicians the
flexibility of intravenous and/or oral dosage formulations, does
not require therapeutic drug monitoring, can be taken with food,
and has a minimal potential for drug interactions, making it a
potentially important treatment option for serious skin infections,
especially in regions where healthcare services may be difficult to
access.”
Lyn Baranowski, Melinta’s SVP of corporate development and
strategy, added, “Eurofarma has been a strong and motivated partner
to date, and we are excited to report on their regulatory
submission in Argentina, the first for delafloxacin outside of the
United States. Eurofarma plans to complete additional submissions
within their Latin American territories in the coming months, with
expectations to launch in a selection of countries in late
2018.”
“The regulatory submission of delafloxacin in Argentina
represents an important strategic milestone for Eurofarma,” says
Martha Penna, VP of Innovation of Eurofarma. “We are a
company that is committed to providing new and innovative options
for the providers and the patients they serve, and we think upon
approval, delafloxacin will be an important option for treating
serious skin infections throughout Latin America,” added
Martha.
Under an agreement initiated in 2015 and expanded in 2017,
Eurofarma Laboratórios is responsible for obtaining regulatory
approval for delafloxacin in 19 countries: Argentina, Belize,
Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic,
Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua,
Panama, Paraguay, Peru, Uruguay and Venezuela. Melinta received an
undisclosed upfront payment upon signing of the agreement and will
receive milestones and royalties on future sales.
About Delafloxacin
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) and are
marketed in the U.S. under the trade name Baxdela™. 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
In the U.S., 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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