MORRISTOWN, N.J., May 07, 2019 (GLOBE NEWSWIRE) -- Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, announced today that it will present data on its portfolio, including results from its real-world registry studies of VABOMERE® (meropenem and vaborbactam), ORBACTIV® (oritavancin), and MINOCIN® (minocycline) for Injection at the upcoming Making a Difference in Infectious Diseases (MAD-ID) 2019 Annual Meeting held from May 8-11 2019 in Orlando, Florida.
"Our presentations demonstrate Melinta’s continued commitment to combatting antimicrobial resistance by helping to inform clinical decision-making for the responsible and sustainable use of our antibiotics,” said Sue Cammarata, M.D., chief medical officer of Melinta.
Real-World Registry Studies:
- Meropenem/Vaborbactam versus Ceftazidime/Avibactam for Treatment of Carbapenem-resistant Enterobacteriaceae Infections, R. Ackley et al. (Poster: 39 OR FRS)
- Meropenem/Vaborbactam in Patients with Carbapenem-resistant Enterobacteriaceae Gram-negative Blood Stream Infection: A Case Series, S. Alosaimy et al. (Poster: 121 OR FRS)
- Real-World Efficacy and Safety of Oritavancin Multiple Dose Treatment in Patients with Complicated Gram-Positive Infections, M. Sierra-Hoffman et al. (Poster: 25 OR)
- Minocycline IV is Effective and Well-tolerated in the Treatment of Pneumonia and Bacteremia Due to Stenotrophomonas maltophilia, M. Sierra-Hoffman et al. (Poster: 26 OR)
Additional Poster Presentations:
BAXDELA® (delafloxacin)
- Use of the Combination Antibiogram in the Era of MDR Gram-negative Pathogens, K. Klinker (Poster: 29 E)
- Pathogen Type and Inappropriate Empiric Therapy (IET) in Culture-Positive Skin and Soft Tissue Infection (SSS) among Hospitalized Patients in the U.S., 2015-2017, S. Cammarata et al. (Poster: 24 E)
- Outcomes in Patients with History of Cardiac or Vascular Disease (CV) During Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) with Delafloxacin (DLX) vs Vancomycin/Aztreonam (VAN/AZ), G. Oguchi Et Al. (Poster: 27 E)
- Resolution of Signs and Symptoms (S&S) of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) with Delafloxacin (DLX) IV/oral therapy, J. Pullman et al. (Poster: 30 E)
- Evaluation of Delafloxacin Activity and Treatment Outcome for Phase 3 Acute Bacterial Skin and Skin Structure Infection Clinical Trial Anaerobic Isolates, D. Shortridge et al. (Poster: 38 E)
VABOMERE® (meropenem and vaborbactam)
- Epidemiology and Outcomes of Carbapenem Resistance Among Patients with Hospital-Acquired and Ventilator-Associated Pneumonia, M. Zilberberg et al. (Poster: 23 E)
- Predicting Carbapenem Resistance Among Gram-Negative Pathogens in Complicated Urinary Tract Infections, M. Zilberberg Et Al. (Poster: 37E)
ORBACTIV® (oritavancin)
- Comparisons of 30-Day Admission and 30-Day Total Healthcare Costs Between Patients Who Were Treated With Oritavancin (ORI) or Vancomycin (VAN) for a Skin Infection in the Outpatient Setting, T. Lodise et al. (Poster: 28 E)
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 U.S. marketed products include BAXDELA® (delafloxacin), VABOMERE® (meropenem and vaborbactam), ORBACTIV® (oritavancin), and MINOCIN® (minocycline) for Injection. 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, including statements related to guidance. 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 and include statements regarding: expectations with respect to our financial position, results and performance. 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, strategies or prospects 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 and risks related to our ability to obtain additional capital to fund future operations; risks related to the satisfaction of the closing conditions for the remaining two disbursements under the loan agreement with Vatera, including any consequences of a failure to close on the two disbursements under the Vatera loan financing; risks related to compliance with the covenants under our facilities with Vatera and Deerfield; uncertainties of cash flows and inability to meet working capital needs as well as other milestone, royalty and payment obligations, including as a result of the outcome of the pending litigation with respect to, and any requirement to make, payments potentially due under our purchase agreement with The Medicines Company; risks that may arise from the consummation of the Vatera loan financing and the effectiveness of the amendment to the Deerfield facility agreement, including potential dilution to our stockholders and the fact that Vatera will beneficially own a substantial portion of our common stock; the fact that our independent registered public accounting firm’s report on the Company’s 2016, 2017, and 2018 financial statements contains an explanatory paragraph that states that 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 the 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 number of shares of common stock may be sold into the public markets by one or more of our large stockholders 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, 2018, our Revised Definitive Proxy Statement filed January 29, 2019, 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:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com
Investor Inquiries:
Susan Blum
+1 312-767-0296
ir@melinta.com