Melinta Therapeutics to Present Detailed Results from Vabomere TANGO II Trial as well as New In Vitro and In Vivo Findings fr...
April 16 2018 - 7:00AM
Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage
company discovering, developing and commercializing novel
antibiotics to treat serious bacterial infections, today announced
that a total of 12 presentations are planned at the upcoming
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID) meeting April 21-14, 2018 in Madrid, Spain. Detailed
results from the Phase 3 TANGO II study of Vabomere™ (meropenem and
vaborbactam) in patients with known or suspected
carbapenem-resistant Enterobacteriaceae (CRE) will be presented in
a series of six oral and poster presentations.
TANGO II was a randomized, open-label Phase 3 trial that
enrolled patients with complicated urinary tract infection, acute
pyelonephritis, hospital-acquired/ventilator-associated bacterial
pneumonia, bacteremia or complicated intra-abdominal infection due
to known or suspected CRE. Vabomere was approved by the U.S. Food
and Drug Administration in 2017 for the treatment of adult patients
with complicated urinary tract infections, including
pyelonephritis, caused by designated susceptible
Enterobacteriaceae.
Melinta’s TANGO II presentations are as following:
- Oral Session (OS009) - Predicting carbapenem resistance among
Gram-negative pathogens in complicated urinary tract infections.
4/21/2018 8:57 - 9:07am
- Paper Poster (PS018) - Meropenem-vaborbactam versus
best-available therapy for carbapenem-resistant Enterobacteriaceae
infections in TANGO II: outcomes in patients with cancer. 4/21/2018
3:30 - 4:30pm
- Mini-oral Flash Session (OF081) - Meropenem-vaborbactam versus
best available therapy for carbapenem-resistant Enterobacteriaceae
infections in TANGO II: outcomes in all treated patients regardless
of pathogen. 4/22/2018 11:42 - 11:45am
- ePoster Mini Oral Session (OE112) - Meropenem-vaborbactam
versus best available therapy for infections due to
carbapenem-resistant Enterobacteriaceae in TANGO II: impact of
prior antibiotic failure on clinical outcomes. 4/22/2018 4:48 –
4:53pm
- Paper Poster Session (PS055) - Activity of
Meropenem-Vaborbactam against Enterobacteriaceae Isolates Collected
During 2016. 4/22/2018 13:30 – 14:30
- Paper Poster Session (PS111) - Ex vivo characterization of
effects of renal replacement therapy modalities and settings on
pharmacokinetics of meropenem-vaborbactam. 4/24/2018 12:30 -
1:30pm
Analyses of demographic and pathogen distribution in patients
presenting with acute bacterial skin and skin structure infections
(ABSSSIs) as well as in vitro efficacy findings for Baxdela™
(delafloxacin) will also be discussed during poster sessions during
ECCMID, as follows:
- ePoster mini-oral Session (EV016) - Demographics of culture
positive patients in the admission period with skin and skin
structure infection in the US: a multicenter evaluation of pathogen
distribution. 4/21/2018 8:00am - 6:00pm
- Paper Poster Session (PS034) - In vitro evaluation of
delafloxacin activity when tested against contemporary European
community-acquired bacterial respiratory tract infection isolates
(2014-2017): Results from the SENTRY Antimicrobial Surveillance
Program. 4/22/2018 12:30 - 1:30pm
- Paper Poster Session (PS105) - A multicentre evaluation of
pathogen distribution in culture-positive patients admitted with
skin and skin-structure infection in the US. 4/24/2018 12:30 -
1:30pm
An update on the company’s ESKAPE Pathogen Program will be
provided in three oral and poster presentations. These
presentations, which highlight the in vitro and in vivo activity of
a novel pyrrolocytosine lead investigational compound are scheduled
as follows:
- Paper Poster Session (PS006) - Progress in the ESKAPE Pathogen
Program: the in vitro profile of an advanced lead, RX-P2382.
4/21/2018 3:30 - 4:30pm
- Paper Poster Session (PS009) - Progress in the ESKAPE Pathogen
Program: the exploratory in vivo toxicological profile of an
advanced lead, RX-P2382. 4/21/2018 3:30 - 4:30pm
- Oral Session (OS046) - Progress in the ESKAPE Pathogen Program:
the in vivo profile of an advanced lead, RX-P2382. 4/21/2018 4:54 -
5:04pm
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 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
StatementsCertain 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: the fact that we have incurred significant operating losses
since inception and will incur continued losses for the foreseeable
future; our limited operating history; our need for future capital;
uncertainties of cash flows and inability to meet working capital
needs as well as other milestone, royalty and payment obligations;
the fact that our independent registered public accounting firm’s
report on the Company’s 2016 and 2017 financial statements contains
an explanatory paragraph that states that the our recurring losses
from operations and our need to obtain additional capital raises
substantial doubt about our ability to continue as a going concern;
our substantial indebtedness; risks related to our commercial
launches of our products and our inexperience as a company in
marketing drug products; the degree of market acceptance of our
products among physicians, patients, health care payors and the
medical community; the pricing we are able to achieve for our
products; failure to obtain and sustain an adequate level of
reimbursement for our products by third-party payors; inaccuracies
in our estimates of the market for and commercialization potential
of our products; failure to maintain optimal inventory levels to
meet commercial demand for any of our products; risks that our
competitors are able to develop and market products that are
preferred over our products; our dependence upon third parties for
the manufacture and supply of our marketed products; failure to
achieve the benefits of our recently completed transactions
with Cempra and The Medicines Company; failure to establish
and maintain development and commercialization collaborations;
uncertainty in the outcome or timing of clinical trials and/or
receipt of regulatory approvals for our product candidates;
undesirable side effects of our products; failure of third parties
to conduct clinical trials in accordance with their contractual
obligations; our ability to identify, develop, acquire or
in-license products; difficulties in managing the growth of our
company; the effects of recent comprehensive tax reform; risks
related to failure to comply with extensive laws and regulations;
product liability risks related to our products; failure to retain
key personnel; inability to obtain, maintain and enforce patents
and other intellectual property rights or the unexpected costs
associated with such enforcement or litigation; risks relating to
third party infringement of intellectual property rights; our
ability to maintain effective internal control over financial
reporting; unfavorable outcomes in any of the class action and
shareholder derivative lawsuits currently pending against the
Company; and the fact that a substantial amount of shares of common
stock may be sold into the public markets by one or more of our
large shareholders in the near future. 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,
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: David
Belian (203) 848-6276
Investor Inquiries: Lisa DeFrancesco (847) 681-3217
Raj Mistry (312) 801-2051
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