NEW HAVEN, Conn., May 08, 2018 (GLOBE NEWSWIRE) — Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced a significant corporate presence at the upcoming Making a Difference in Infectious Diseases (MAD-ID) 2018 Annual Meeting from May 9-12, 2018 in Orlando, Florida. Melinta will be presenting 12 posters summarizing results from clinical and in vitro studies of Baxdela™ (delafloxacin), Orbactiv® (oritavancin) for injection and Vabomere™ (meropenem and vaborbactam).
Detailed safety and efficacy findings from the Phase 3 PROCEED studies of Baxdela in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) will be presented. In addition, the results of susceptibility testing on over 36,000 Gram-positive and -negative pathogens collected from U.S. and European medical centers between 2014 and 2016 will be reported in the following posters:
- 100E – Activity of Delafloxacin When Tested against Bacterial Surveillance Isolates Collected in the U.S. and Europe during 2014–2016 as Part of a Global Surveillance Program
- 101E – Comparison of Safety Profile of Delafloxacin (DLX) versus Vancomycin/Aztreonam (VAN/AZ) in the Treatment of Patients (Pts) with Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Integrated Safety Findings from Two Phase III Studies
- 105E – Impact of Delafloxacin (DLX) and Vancomycin/Aztreonam (VAN/AZ) on Resolution of Signs and Symptoms of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Analyses of Orbactiv activity in vitro, in an out-patient setting and from a patient registry will also be presented:
- 93E – Real-World Experience with Single- and Multi-Dose Oritavancin
- 103E – Single-dose Oritavancin Avoids Hospitalization and Shortens Length of Stay for Treatment of Skin and Soft Tissue Infections in US Hospitals
- 106E – Updated Analysis of Oritavancin Activity against Gram-Positive Clinical Isolates Responsible for Bloodstream Infections in United States and European Hospitals (2014–2016)
In vitro susceptibility testing will be presented for vaborbactam, the beta-lactamase inhibitor (BLI) component of Vabomere. Additionally, in vitro and clinical results of Vabomere, highlighting its activity in challenging patient populations, will also be presented:
- 91E – Meropenem-Vaborbactam Activity against Enterobacteriaceae Isolates, Including Carbapenem-Resistant and Carbapenemase-Producing Isolates, Collected in United States (US) Hospitals During 2016
- 94E – Hospital and ICU Length of Stay (LOS) with Meropenem-Vaborbactam (M-V) versus Piperacillin-Tazobactam (P-T) in Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis (AP) in TANGO 1
- 95E – Vaborbactam (VAB) is not affected by KPC-2 and KPC-3 Variants Containing Asp179Tyr Amino Acid Substitution that are Resistant to Ceftazidime (CAZ) Potentiation with Avibactam
- 102E – Meropenem-Vaborbactam versus Best Available Therapy for Carbapenem-Resistant Enterobacteriaceae Infections in TANGO II: Outcomes in Patients with Cancer
- 104E – Meropenem-Vaborbactam versus Best Available Therapy for Infections due to Carbapenem-Resistant Enterobacteriaceae in TANGO II: Impact of Prior Antibiotic Failure on Clinical Outcomes
The use of combination antibiograms that provide physicians with guidance on the activity against specific pathogens will also be discussed by Melinta at MAD-ID:
- 92E – Re-Birth of the Combination Antibiogram in the Era of MDR-Enterobacteriaceae
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 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: 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
dbelian@melinta.com
Investor Inquiries:
Lisa DeFrancesco
(847) 681-3217
ldefrancesco@melinta.com
Raj Mistry
(312) 801-2051
rmistry@melinta.com
