Melinta Therapeutics Announces Initiation of Program for Radezolid in Patients with Bacterial Vaginosis
January 18 2018 - 6:00AM
Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage
company developing and commercializing novel antibiotics to treat
serious bacterial infections, announced today that its partner has
commenced a new program for a topical formulation of radezolid, a
second-generation oxazolidinone antibiotic discovered by Melinta
scientists, in preparation for submitting an Investigational New
Drug (IND) application to the U.S. Food and Drug Administration
(FDA) for the treatment of patients with bacterial vaginosis.
Radezolid is also being studied by Melinta’s partner in a Phase 2
clinical study for the treatment of mild-to-moderate acne
vulgaris.
“Bacterial vaginosis (BV) represents a complex change in vaginal
flora, with overgrowth of certain vaginal bacterial species such as
Gardnerella vaginalis. If left untreated, BV can increase a
person’s risk of contracting a sexually transmitted disease (STD)
or HIV, and may increase the risk of premature delivery and low
birth weight in children born from women with BV,” explained Sue
Cammarata, M.D., Melinta’s chief medical officer. “Radezolid has
demonstrated in-vitro activity against the species of bacteria
often associated with bacterial vaginosis, which suggests it may be
effective in this indication.”
The United States Food and Drug Administration has also recently
designated radezolid a Qualified Infectious Disease Product (QIDP)
for the indication of bacterial vaginosis. QIDP designation
provides certain incentives for companies developing new
antibiotics, including an additional five years of market
exclusivity, priority NDA review and eligibility for fast-track
development status.
In January 2015, Melinta out-licensed radezolid to an
undisclosed partner for topical indications while retaining the
option to co-develop or fully regain rights to radezolid upon
completion of specific development milestones. The deal structure
provides Melinta with a long-term financial return and affords
Melinta the opportunity to participate in radezolid’s future
development and commercialization.
About Radezolid Radezolid is a
second-generation oxazolidinone antibiotic discovered by Melinta
scientists using proprietary, structure-based design, to achieve
higher ribosomal binding affinity, minimal off-target activity, and
a broader spectrum of antimicrobial activity than is currently
available in the class. For more information, please visit the
company website.
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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