|Thursday October 5th||3:03 PM||VABOMERE||New Antibiotics: What's in the Pipeline Overview of Meropenem-Vaborbactam Presentation author: M. Dudley||Symposium Room 20ABCD|
|Friday October 6th||7:00 AM to 8:15 AM||VABOMERE||Pipeline 2.0: New Antibiotics: What's in the Pipeline Panelists: M. Dudley, The Medicines Company; S. Cammarata, Melinta Therapeutics; E. Ellis-Grosse, Zavante Therapeutics; , R. Echols, ID3C; I. Friedland, Friedland Strategic Consulting; P .McGovern, Paratek Pharmaceuticals; Steven P. Gelone, Nabriva Therapeutics AG; David Huang, Motif BioSciences; Amanda Paschke, Merck & Co., Inc.; P. Horn, Tetraphase Pharmaceuticals||Panel Discussion and Q&A Room 06DE|
|Friday October 6th||12:30 PM to 2:00 PM||VABOMERE||Session: Expanded Spectrum - New Antimicrobial Susceptibility Testing Activity of Meropenem-Vaborbactam Against Enterobacteriaceae Isolates Carrying bla KPC Collected Worldwide Presentation authors: M. Castanheira, R.E. Mendes, L.R. Duncan, L.N. Woosley, R.K. Flamm||Poster 1234 Hall CD|
|Saturday October 7th||12:30 PM to 2:00 PM||VABOMERE||Session: Clinical Study with New Antibiotics and Antifungals Meropenem-Vaborbactam vs. Piperacillin-Tazobactam in TANGO I (a Phase 3 Randomized, Double-blind Trial): Outcomes by Baseline MIC in Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis Presentation authors: T. Walsh, T. Bhowmick, R. Darouiche, V. Zaitsev, E. Giamarellos-Bourboulis, A. Shorr, E. Fedosiuk, T. File Jr., J. Loutit, O. Lomovskaya, M. Dudley, D. Perlin||Poster 1866 Hall CD|
|Saturday October 7th||12:30 PM to 2:00 PM||VABOMERE||Session: Clinical Study with New Antibiotics and Antifungals Meropenem-Vaborbactam vs. Best Available Therapy for Carbapenem-Resistant Enterobacteriaceae Infections in TANGO II: Primary Outcomes by Site of Infection Presentation authors: R. Wunderink, E. Giamarellos-Bourboulis, G. Rahav, A. Mathers, M. Bassetti, J. Solomkin, E. Alexander, J. Loutit, S. Zhang, M. Dudley, K. Kaye||Poster 1867 Hall CD|
|Saturday October 7th||12:30 PM to 2:00 PM||VABOMERE||Session: Clinical Study with New Antibiotics and Antifungals Clinical Outcomes of Serious Infections due to Carbapenem-Resistant Enterobacteriaceae (CRE) in TANGO II, a Phase 3, Randomized, Multi-National, Open-Label Trial of Meropenem-Vaborbactam (M-V) Versus Best Available Therapy (BAT) Presentation authors: K. Kaye, J. Vazquez, A. Mathers, G. Daikos, E. Alexander, J. Loutit, S. Zhang, M. Dudley, O. Cornely||Poster 1862 Hall CD|
|Saturday October 7th||12:30 PM to 2:00 PM||VABOMERE||Session: Clinical Study with New Antibiotics and Antifungals Assessment of MIC Increases with Meropenem-Vaborbactam and Ceftazidime-Avibactam in TANGOII (a Phase 3 Study of the Treatment of CRE Infections) Presentation authors: O. Lomovskaya, M. Castanheira, J. Vazquez, K. Kaye, K. Nelson, D. Sun, E. Alexander, M. Dudley, M. Yin||Poster 1874 Hall CD|
|Saturday October 7th||12:30 PM to 2:00 PM||VABOMERE||Session: Clinical Study with New Antibiotics and Antifungals Meropenem-Vaborbactam: Outcomes in Subjects with Renal Impairment in Phase 3 Studies TANGO I and II Presentation authors: A. Mathers, W. Hope, K. Kaye, J. Loutit, E. Alexander, M. Dudley, J. Vazquez||Poster 1879 Hall CD|
|Saturday October 7th||12:30 PM to 2:00 PM||VABOMERE||Session: Clinical Study with New Antibiotics and Antifungals Meropenem-Vaborbactam Pharmacokinetics in Subjects with Chronic Renal Impairment, Including Hemodialysis Presentation authors: C. Rubino, D. Griffith, S. Bhavnani, J. Loutit, B. Lohse, M. Dudley, P. Ambrose||Poster 1835 Hall CD|
|Saturday October 7th||12:00 PM to 2:30 PM||VABOMERE||Session: Clinical Study with New Antibiotics and Antifungals Meropenem-Vaborbactam vs. Best Available Therapy for Carbapenem-Resistant Enterobacteriaceae Infections in TANGO II:Outcomes in Immunocompromised Patients Presentation authors: D. Paterson, E. J. Kwak, T. Bhowmick, E. Alexander, J. Loutit, S. Zhang, M. Dudley, T. Walsh||Poster 1868 Hall CD|
|Saturday October 7th||12:00 PM to 2:30 PM||VABOMERE||Session: Clinical Study with New Antibiotics and Antifungals Meropenem-Vaborbactam Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses as Support for Dose Selection in Patients with Normal Renal Function and Varying Degrees of Renal Impairment Presentation authors: S. Bhavnani, M. Trang, D. Griffith, O. Lomovskaya, J. Hammel, J. Loutit, M. Dudley, P. Ambrose, C. Rubino||Poster 1852 Hall CD|
|Thursday October 5th||12:30 PM to 2:00 PM||MINOCIN||Session: Use of PK/PD to optimize existing antibiotics and antifungal Pharmacokinetics and Tissue Distribution of Minocycline following Intravenous Administration in Rabbits Presentation authors: V. Petraitis, R. Petraitiene, B. W. Maung, T. Nolan, D. Griffith, M. Dudley, T. Walsh||Poster 804 Hall CD|
|Friday October 6th||12:30 PM to 2:00 PM||ORBACTIV||Session: Expanded Spectrum - New Antimicrobial Susceptibility Testing Analysis of Oritavancin Activity against Gram-Positive Clinical Isolates Responsible for Bacterial Endocarditis in United States and European Hospitals (2008-2016) Presentation authors: M.A. Pfaller, H.S. Sader, D. Shortridge, R.K. Flamm, R.E. Mendes||Poster 864 Hall CD|
IMPORTANT SAFETY INFORMATIONContraindications 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.
- Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including VABOMERE, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued.
- 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 nonsusceptible organisms.
Warnings and Precautions Tooth DevelopmentMINOCIN® 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 prescribing information. About ORBACTIV® (oritavancin) for Injection 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). 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 prescribing information. About The Infectious Disease Business The Medicines Company Infectious Disease Business (MDCO IDC) 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 recently received approval for VABOMERE 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.
In addition to the development and approval of VABOMERE, MDCO IDC has, since 2014, successfully developed and launched two antibiotics against serious infections: ORBACTIV ® (oritavancin) for the treatment of acute bacterial skin and skin-structure infections in adults, caused by designated pathogens, including methicillin-resistant Staphylococcus aureus, 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 spp., a pathogen classified by the CDC to be a serious antimicrobial resistance threat. For more information on these products, including their respective important safety information and package inserts, please see www.ORBACTIV.com and www.MINOCINiv.com.About BARDA In February 2014, The Medicines Company Infectious Disease Business was awarded a cost-sharing contract by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS), of which $55.8 million in federal funds have been obligated to date to support the development of VABOMERE. In September 2016, The Medicines Company entered into a new strategic partnership with BARDA that will provide the Company with the potential for up to $132 million to support the development of new antibiotics to fight drug-resistant, gram-negative infections (HHSO100201600026C). The partnership was established under HHS's Other Transactional Authority (OTA), and is a distinctive, flexible, portfolio-based approach to funding drug development. The Medicines Company was awarded $32 million in initial funding, and up to an additional $100 million (pending the availability of funding) over approximately five years, if all options to extend the partnership are exercised by BARDA and The Medicines Company. The initial $32 million award supports further development of VABOMERE as well as advancement of the Company's early stage pipeline. Funding provided under any subsequent options exercised by BARDA and The Medicines Company, will also support the advancement of antibiotics in MDCO IDC's portfolio of new antibiotic drug candidates targeting drug resistant bacteria.
About The Medicines CompanyThe 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 serious infectious disease care and cardiovascular care. The Company is headquartered in Parsippany, New Jersey, with a global innovation center in California. 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 August 9, 2017, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.