World News: 13:00 GMT Tuesday 2nd October 2018. [Melinta Therapeutics via Globe Newswire via SPi World News]
NEW HAVEN, Conn., Oct. 02, 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 that results from the Phase III TANGO 2 study of Vabomere™ (meropenem and vaborbactam) have been published in . Data from TANGO 2 showed that Vabomere was associated with increased clinical cure, and decreased mortality compared to “best available therapy” (BAT).
Vabomere was approved by the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae. The Vabomere approval was supported by TANGO 1, a Phase III, multi-center, randomized, double-blind, double-dummy study evaluating the efficacy, safety and tolerability of Vabomere compared to piperacillin-tazobactam in the treatment of cUTI. The Vabomere development program was supported by a cost-share contract with the Biomedical Advanced Research and Development Authority (BARDA).
Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO) 2 was a multi-center, randomized, open-label, pathogen-directed, descriptive study of monotherapy VABOMERE 4 g IV infused every eight hours over three hours for up to 14 days compared with BAT for the treatment of patients with cUTI, acute pyelonephritis (AP), complicated intra-abdominal infection (cIAI), hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP), and bacteremia due to carbapenem-resistant Enterobacteriaceae (CRE).
TANGO 2 demonstrated cure rates of 65.6% (21/32) vs 33.3% (5/15) at end of therapy (EOT) and 59.4% (19/32) vs 26.7% (4/15) at test of cure (TOC) for Vabomere and BAT, respectively, in patients with a baseline CRE organism. Day 28 all-cause mortality was 15.6% (5/32) for patients treated with Vabomere vs 33.3% (5/15) for patients treated with BAT.
In the safety population, Vabomere was well-tolerated in these seriously ill patients, whether looking at the incidence of treatment-emergent adverse events (TEAEs) compared to BAT [84.0% (42/50) vs 92.0% (23/25)], severe TEAEs [14.0% (7/50) vs 28.0% (7/25)], drug-related TEAEs [24.0% (12/50) vs 44.0% (11/25)], and serious AEs [34.0% (17/50) vs 44.0% (11/25)]. The most common treatment-related adverse events for Vabomere were diarrhea, anemia, and hypokalemia. Vabomere was associated with fewer AEs and nephrotoxicity compared to BAT.
“These published results further demonstrate the safety and effectiveness of Vabomere and underscore our belief that it represents an important new treatment option for patients with serious infections, such as cUTI,” said Dan Wechsler, President and CEO of Melinta. “We believe that Vabomere represents a significant new advancement in addressing the increasing incidence of KPC-producing Enterobacteriaceae, for which there are currently limited treatment options.”
“Treatment options for CRE infections are limited and such infections remain associated with high clinical failure and mortality rates, particularly in vulnerable patient populations,” said Dr. Richard Wunderink, MD, Professor of Medicine, Northwestern University. “It is essential that products such as Vabomere continue to be developed and brought to market where they can play an important role in treating these infections.”
TANGO 2 is the first prospective, Phase III comparative trial of monotherapy with a novel antibiotic in patients with CRE infections.
Data from TANGO 2 was used by the Centers for Medicare & Medicaid Services (CMS) in its decision to grant a new technology add-on payment (NTAP) for Vabomere, effective Oct. 1, 2018.
The NTAP program will provide hospitals with a payment, in addition to the standard-of-care Diagnostic Related Group (DRG) reimbursement, of up to 50% of the cost of Vabomere for a period of two to three years, effective in the 2019 fiscal year starting on October 1, 2018. CMS has assigned a maximum payment of $5,544.00 for a Medicare patient treated with Vabomere. Over 80% of Vabomere’s current and projected utilization among all patients is in the hospital inpatient setting.
VABOMERE (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: , , and complex. Indications supported by TANGO 2 data have not yet been formally reviewed by the FDA.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs.
Warnings and Precautions
Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam antibacterial drug. If an allergic reaction to VABOMERE occurs, discontinue the drug immediately.
Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.
The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. If administration of VABOMERE is necessary, consider supplemental anticonvulsant therapy.
In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported.
Alert patients receiving VABOMERE on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment.
Prescribing VABOMERE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of drug-resistant bacteria.
As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of non-susceptible organisms.
The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea.
Please see www.VABOMERE.com for the full FDA-approved prescribing information.
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; 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 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.
Globe Newswire: 13:00 GMT Tuesday 2nd October 2018
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