NEW HAVEN, Conn., May 11, 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 the launch of a new antibiotic stewardship program designed to address the growing threat of antimicrobial resistance (AMR).
The Melinta Antimicrobial Stewardship Program will further Melinta’s leadership in the fight against the global public health threat of antimicrobial resistance (AMR) by implementing comprehensive measures and metrics within the company’s commercial, manufacturing and research and development operations designed to promote the responsible and sustainable use of its current and future antibiotic portfolio.
Melinta will take concrete steps as part of the program, including conducting AMR surveillance efforts such as post-marketing susceptibility testing and real-world use registries; implementing stewardship-focused promotional standards; evaluating economic models to support the responsible and sustainable use of its products; and undertaking educational programming with healthcare providers.
In addition, Melinta will continue to work with its manufacturing partners to develop and implement environmental risk-management strategies for minimizing the impact of antibiotic discharge. Within its R&D operations, the company will continue to focus on the development of breakthrough antibiotics for bacterial “superbugs” through its ESKAPE Pathogen Program while advancing the development of its existing portfolio of antibiotics.
Melinta will host an expert panel session today at the 21st Annual MAD-ID Meeting, the leading industry summit focused on antimicrobial stewardship and patient care, to introduce the program and discuss opportunities to leverage collective expertise to combat AMR.
“Antimicrobial resistance is an urgent global health threat and, as the industry’s largest pure-play antibiotics company, Melinta is committed to demonstrating leadership in the fight against it,” said Dan Wechsler, President and CEO of Melinta. “As a company, Melinta’s aim is to meet the continually evolving threat of bacterial infections by discovering, developing and commercializing a continual stream of novel antibiotics. The launch of our Antimicrobial Stewardship Program is an important tenet of our mission, vision and culture, as we focus on providing new and targeted therapies that are used when they are the right choice for the right pathogen and the right patient.”
The launch of Melinta’s new program is the first step in the company’s expanded effort to play a leading role the fight against antimicrobial resistance, and builds on the company’s existing leadership, including its position as a signatory company to the Industry Declaration on AMR at the World Economic Forum in Davos, Switzerland in 2016. Melinta plans to continually expand and evolve the program and will provide additional details on its commitments in the coming months.
Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die as a direct result of these infections, according to the U.S. Centers for Disease Control (CDC)i. Many more people die from other conditions that were complicated by an antibiotic-resistant infection.
At the same time, 5.7 million people globally die each year from treatable infections because they lack access to effective antimicrobials.ii
Resistant infections add significant costs to the U.S. healthcare system as a result of prolonged and/or costlier treatments, extended hospital stays and additional doctor visits. Studies estimate that antibiotic resistance in the U.S. adds approximately $20 billion in excess healthcare costs, with additional costs to society for lost productivity as high as $35 billion a year.iii
Today, the incidence of resistant strains of dangerous pathogens is on the rise, with many microbes resistant to more than one drug (multidrug-resistant or MDR), others resistant to most drugs (extensively drug-resistant or XDR), and some resistant to all known drugs (pan-resistant or PDR).
The use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Antibiotics are among the most commonly prescribed drugs used in human medicine. However, up to 50 percent of all the antibiotics prescribed for people are not needed or are not optimally effective as prescribed.iv
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
Investor Inquiries:
Lisa Defrancesco
(847) 681-3217
Raj Mistry
(312) 801-2051
i https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf
ii https://www.ncbi.nlm.nih.gov/pubmed/26243238
iii https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf
iv https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf