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The Medicines Company to Present Data at ECCMID 2017 on Infectious Disease Portfolio Including Investigational Antibiotic Meropenem-VaborbactamThe Medicines Company (NASDAQ:MDCO) today announced that data from its portfolio of antimicrobial products and late-stage product candidates will be featured in presentations at the 27th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2017) to be held April 22-25, 2017, in Vienna, Austria. The Company will present data on its investigational antibiotic, meropenem-vaborbactam, from the pivotal TANGO 1 trial that compared it to piperacillin-tazobactam in the treatment of complicated urinary tract infections (cUTIs). Additional data on meropenem-vaborbactam's in vitro activity against clinical isolates of carbapenem-resistant Enterobacteriaceae (CRE), and in experimental treatment models will also be presented as will data from studies of Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection. "The scope and diversity of the research being presented at ECCMID 2017 provides evidence of The Medicines Company's strong commitment to advancing the discovery and development of innovative antimicrobial drugs for pathogens that The World Health Organization recently identified as a critical need," said Michael Dudley, PharmD, FIDSA, Senior Vice President, Head of R&D and Co-Leader of The Medicines Company's Infectious Disease Business. Mike McGuire, Senior Vice President and Co-Leader of The Medicines Company's Infectious Disease Business added, "We were delighted with the Food and Drug Administration (FDA) acceptance of our NDA for meropenem-vaborbactam. We believe that, if approved later in 2017, meropenem-vaborbactam will make a major contribution to patient care and demonstrate The Medicines Company's continued commitment to leadership in treatment of antimicrobial drug-resistance." Tony Kingsley, President and Chief Operating Officer of The Medicines Company, summarized, "With The Medicines Company's infectious disease franchise we have a fully-integrated biopharmaceutical company with capabilities from discovery to commercialization. We are tackling major antibacterial threats which we also believe represent attractive global market opportunities. We are committed to growing this focused, effective, and fully- integrated infectious disease business." ECCMID 2017, the 27th European Congress of Clinical Microbiology and Infectious Diseases, gathers the world's leading experts in infectious disease management together to discuss the latest developments in infectious disease, infection control and clinical microbiology. Details of presentations are provided below. The complete program of titles, abstracts, and electronic versions of posters can be accessed on the ECCMID website at http://www.eccmid.org/. All times listed below are in European Central Time.
About Meropenem-Vaborbactam Meropenem-vaborbactam, an investigational agent not approved for commercial use in any market, is a combination of the carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), administered as a fixed combination by IV infusion. It is being developed to treat serious gram-negative infections, such as complicated urinary tract infections, including those infections caused by bacteria resistant to currently available carbapenems. Meropenem-vaborbactam has been granted Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections and has been designated by the FDA as a Qualified Infectious Disease Product (QIDP), as authorized under the GAIN Act. Meropenem-vaborbactam was designed to address gram-negative bacteria that produce new beta-lactamase enzymes that have spread in the United States and Europe, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme. KPC-producing bacteria are the predominant form of carbapenem-resistant Enterobacteriaceae (CRE) in the United States and are classified by the U.S. Centers for Disease Control and Prevention (CDC) to be an urgent antimicrobial resistance threat. A pivotal Phase III clinical trial for meropenem-vaborbactam in cUTI was successfully completed in 2016, and our NDA was accepted for filing by the FDA with a priority review classification in February 2017. About MINOCIN® (minocycline) for Injection In the United States, MINOCIN® (minocycline) for Injection is indicated for the treatment of infections due to susceptible strains of designated microorganisms, including Acinetobacter species bacteria. For additional full list of indications and designated susceptible pathogens, please see the full US prescribing information available at www.minociniv.com. Intravenous minocycline is an investigational agent in the EU. Important Safety Information Contraindications MINOCIN® for Injection is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation. Warnings and Precautions Tooth Development MINOCIN® for Injection, like other tetracycline-class antibacterials, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy, or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Skeletal Development All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy. Dermatologic Reaction Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. If this syndrome is recognized, the drug should be discontinued immediately. Anti-anabolic Action The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours. If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity. Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline. Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MINOCIN® for Injection, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Intracranial Hypertension Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including MINOCIN® for Injection. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and MINOCIN® for Injection should be avoided because isotretinoin is also known to cause pseudotumor cerebri. Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize. As with other antibacterial preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibacterial should be discontinued and appropriate therapy instituted. Hepatotoxicity has been reported with minocycline; therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs. Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic antibacterial therapy when indicated. MINOCIN® for Injection contains magnesium sulfate heptahydrate. Because magnesium is excreted primarily by the kidney, serum levels of magnesium should be monitored in patients with renal impairment. Because MINOCIN® for Injection contains magnesium, close monitoring is recommended in patients with heart block or myocardial damage. Prescribing MINOCIN® for Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions For a complete list of adverse reactions that have been observed in patients receiving tetracyclines, consult the full US prescribing information for MINOCIN® for Injection. Please see www.minociniv.com for the full US prescribing information. About ORBACTIV® (oritavancin) for Injection In the United States, ORBACTIV® (oritavancin) for Injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and methicillin-resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only). In March 2015, the European Commission granted marketing authorization for ORBACTIV®, which is valid in the 31 countries of the European Economic Area (EEA), plus Norway, Iceland and Liechtenstein. Important Safety Information Contraindications Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV® administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 120 hours (5 days) after ORBACTIV® administration. ORBACTIV® is contraindicated in patients with known hypersensitivity to ORBACTIV®. Warnings and Precautions Coagulation test interference: ORBACTIV® has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours, ACT for up to 24 hours, and D-dimer for up to 72 hours. Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV®. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides. Infusion-related reactions have been reported. Slow the rate or interrupt infusion if infusion reaction develops. Clostridium difficile-associated colitis: Evaluate patients if diarrhea occurs. Concomitant warfarin use: Patients should be monitored for bleeding if concomitantly receiving ORBACTIV® and warfarin. Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis. Prescribing ORBACTIV® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions The most common adverse reactions (= 3%) in patients treated with ORBACTIV® were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. Please see www.orbactiv.com for the full US prescribing information. About The Infectious Disease Business The Medicines Company's Infectious Disease Business (MDCO IDC (News - Alert)) is committed to bringing life-saving antimicrobial products to patients with the most serious drug-resistant infections - infections caused by "super bugs" which are no longer treatable with available antibiotics. MDCO IDC encompasses basic research and drug discovery focused on bacterial mechanisms of drug resistance; drug development focused on the most threatening bacterial diseases; and a distribution and commercial infrastructure that serves the leading hospitals and healthcare facilities in the United States. MDCO IDC is currently developing meropenem-vaborbactam to treat serious gram-negative infections, such as complicated urinary tract infections, including those infections caused by bacteria resistant to currently available carbapenems. MDCO IDC has a leading pipeline of novel agents directed towards existing and emerging multidrug-resistant bacteria. A pivotal Phase III clinical trial for meropenem-vaborbactam was successfully completed in 2016, and our NDA was accepted for filing by the FDA with a priority review classification in February 2017. Since 2014, our team has successfully developed and launched two antibiotics against serious infections: Orbactiv® (oritavancin) for treatment of acute bacterial skin and skin-structure infections in adults, including those due to methicillin-resistant Staphylococcus aureus (MRSA), and a new formulation of Minocin® (minocycline) for Injection, which is among the few FDA-approved agents for the treatment of infections due to Acinetobacter sp., a serious antimicrobial resistance threat. For more information on these products, including their respective prescribing information, please see www.orbactiv.com and www.minociniv.com. About The Medicines Company The Medicines Company is a biopharmaceutical company driven by an overriding purpose - to save lives, alleviate suffering and contribute to the economics of healthcare. The Company's mission is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians and providers in three critical therapeutic areas: serious infectious disease care, cardiovascular care and surgery and perioperative care. The Company is headquartered in Parsippany, New Jersey, with global innovation centers in California and Switzerland. The Medicines Company Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," "potential," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether clinical trials will advance on a timely basis, or at all, or succeed in achieving their specified endpoints; whether physicians, patients and other key decision makers will accept clinical trial results; whether the Company will make regulatory submissions on a timely basis, or at all; whether the Company's regulatory submissions will receive approvals from regulatory agencies on a timely basis, or at all; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission, including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2017, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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