Melinta Therapeutics Partner, Menarini Group, Submits Marketing Authorization Application for Delafloxacin in Europe
08 March 2018 - 11:00PM
Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage
company developing and commercializing novel antibiotics to treat
serious bacterial infections, today announced that The Menarini
Group, Melinta’s commercial and co-development partner, has
submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for delafloxacin (to be marketed
under the trade name Quofenix in Europe) for the treatment of adult
patients with Acute Bacterial Skin and Skin Structure Infections
(ABSSSI). This MAA is based on results of the two Phase 3 PROCEED
studies (NCT01811732 and NCT01984684), which met both FDA- and
EMA-specified primary endpoints.
Under a 2017 agreement, Menarini has exclusive rights to
commercialize delafloxacin (marketed as Baxdela™ in the U.S.) in 68
countries in Europe, Asia-Pacific including China, South Korea, and
Australia (Japan excluded), and the Commonwealth of Independent
States (CIS) including Russia. This submission represents the first
application by Menarini for regulatory approval in their
territory.
“This is an important milestone for Melinta, and if approved
would represent a significant expansion of delafloxacin’s market
reach,” stated Dan Wechsler, Melinta’s president and chief
executive officer. “In clinical studies, delafloxacin demonstrated
potent activity across a broad range of pathogens. The ability to
treat infections including those caused by methicillin-resistant
Staphylococcus aureus (MRSA) with an IV or oral option should
resonate with regulatory bodies and healthcare providers
alike.”
“The regulatory submission of delafloxacin in Europe, after one
year from the signature of the agreement, represents an important
strategic milestone for Menarini. ABSSSIs are among the most common
human bacterial infections, and are associated with considerable
morbidity, especially in subjects with underlying diseases.
Delafloxacin, with its broad in vitro spectrum of activity against
Gram-positive, including MRSA, Gram-negative and as well as
atypical and anaerobe organisms, stands out as a new therapeutic
option in this setting. Thanks to this new molecule, we will keep
contributing to the health of patients all over the world with the
high quality standards that distinguish Menarini,” said P. Mei,
general manager of The Menarini Group.
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
Melinta Therapeutics (NASDAQ:MLNT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Melinta Therapeutics (NASDAQ:MLNT)
Historical Stock Chart
From Jul 2023 to Jul 2024