The Medicines Company Announces Participation in 2014 American College of Emergency Physicians Scientific Assembly
The Medicines Company (NASDAQ:MDCO) will be represented at the American College of Emergency Physicians (ACEP) Annual Scientific Assembly in Chicago, which brings together more than 4,000 emergency medical professionals focused on advancing clinical science that improves the care for millions of Americans who seek first-line treatment through emergency rooms across the country’s hospital systems and centers.
The Medicines Company will participate in InnovatED, a program by ACEP featuring new therapies, technologies and advances in patient care for the emergency medicine community. InnovatED will include educational activities and materials on ORBACTIV, a single dose intravenous antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of Gram-positive microorganisms. InnovatED will also feature CLEVIPREX® (clevidipine), an IV anti-hypertensive treatment for use in patients where oral treatment is not possible or desirable.
Presentations will include the following:
Two e-posters will present additional efficacy outcomes by lesion type and lesion size reduction from the SOLO I & II studies, the pivotal trials for ORBACTIV. The e-posters are:
- Abstract 099: A Single Dose of Oritavancin Compared To 7-10 Days of Vancomycin: Lesion Size Reduction In Phase 3 Studies of ABSSSI – Monday, October 27, 2014 from 10:45 a.m. to 11:45 a.m.
- Abstract 252: Efficacy Outcomes By Lesion Type in Studies of a Single Dose of Oritavancin Compared to 7-10 Days of Vancomycin – Tuesday, October 28, 2014 from 9:30 a.m. to 11:30 a.m.
In addition, Dr. James B. Jones, PharmD, FACEP, Vice President, Medical, Surgery and Perioperative Care, The Medicines Company, will present, "CLEVIPREX for Blood Pressure Control", including a case study from the VELOCITY trial of CLEVIPREX on Wednesday, October 29 from 11:30-11:40 a.m.
“Emergency departments are searching for effective ways to treat skin and skin structure infections that they are increasingly seeing across the U.S,” said Charles Pollack, MD, FACEP, Chair, Department of Emergency Medicine, Pennsylvania Hospital and Professor of Emergency Medicine at the Perelman School of Medicine of the University of Pennsylvania. “These findings from the SOLO studies further underscore the benefit of ORBACTIV in treating ABSSSI, including in the emergency setting.”
“As an aspiring leader in acute and intensive care medicine, The Medicines Company is committed to support the leadership of the American College of Emergency Physicians and its members for their continued efforts to improve care for the more than 125 million patients admitted to U.S. emergency departments each year,” said Dr. Clive Meanwell, Chairman and CEO, The Medicines Company. “This community of health professionals serves as the front door for critical and acute care for millions of Americans, serving in a key role that not only addresses medical needs, but also identifies ways to increase efficiency and reduce in-patient admissions across the hospital care setting.”
The Company looks forward to partnering with ACEP to advance solutions that address critical needs for the nation’s 32,000 emergency medical professionals.
About The Medicines Company Infectious Disease Portfolio
The Medicines Company is well positioned to address the complex problems associated with multi-drug resistant infections. The research projects, development programs, and marketed products span the spectrum of infections caused by certain Gram-positive bacteria, including Methicillin-Resistant Staphylococcus Aureus (MRSA), and Gram-negative infections including Acinetobacter spp, carbapenem-resistant Enterobacteriaceae and other multi-drug-resistant pathogens identified by US Centers of Disease Control as urgent or serious threats. The product pipeline includes CARBAVANCE (meropenem/RPX7009), RPX-602 (new formulation of MINOCIN® (minocycline) for injection), and pre-clinical developmental program of novel investigational agents. ORBACTIV and MINOCIN for injection are two antibiotics approved for use in the US. The product portfolio has the potential to offer clinicians and patients a suite of innovative new antibiotic approaches to tackle many of the most vexing problems in infectious disease today.
The Medicines Company is committed to becoming a leading provider of solutions for acute and intensive care hospitals, specifically focused on improving health and economic outcomes for life-threatening infections.
About ORBACTIVTM (oritavancin)
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 and methicillin–resistant 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).
ORBACTIV is the first and only single-dose intravenous antibiotic approved for the treatment of ABSSSI in the US. The European Medicines Agency accepted for review the Marketing Authorization Application (MAA) for ORBACTIV in Q1 2014, for which the Company is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). A decision from the European Commission is expected during the first half of 2015.
IMPORTANT SAFETY INFORMATION
Use of intravenous unfractionated heparin sodium is contraindicated for 48 hours after ORBACTIV administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 48 hours after ORBACTIV administration.
ORBACTIV is contraindicated in patients with known hypersensitivity to ORBACTIV.
Warnings and Precautions
Concomitant warfarin use: Co-administration of ORBACTIV and warfarin may result in higher exposure of warfarin, which may increase the risk of bleeding. Use ORBACTIV in patients on chronic warfarin therapy only when the benefits can be expected to outweigh the risk of bleeding.
Coagulation test interference: ORBACTIV has been shown to artificially prolong aPTT for up to 48 hours, and may prolong PT and INR for up to 24 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.
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.
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 MINOCIN® (minocycline for injection)
MINOCIN® (minocycline for injection) is FDA-approved and indicated for the treatment of infections due to susceptible strains of designated microorganisms, including Acinetobacter spp. For the full list of indications and designated susceptible pathogens, please see the full prescribing information.
IMPORTANT SAFETY INFORMATION
MINOCIN is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.
MINOCIN, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. The patient should be apprised of the potential hazard to the fetus if the patient becomes pregnant while taking these drugs or uses a tetracycline during pregnancy.
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). Tetracycline drugs, therefore should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.
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.
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.
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.
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.
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 manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline.
Central nervous system side effects including lightheadedness, dizziness or vertigo have been reported.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MINOCIN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.
Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists.
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 therapy when indicated.
Prescribing MINOCIN 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.
For a complete list of adverse reactions that have been observed in patients receiving tetracyclines, consult the full prescribing information for MINOCIN.
Please see www.minociniv.com for the full prescribing information.
About CLEVIPREX™ (clevidipine) Injectable Emulsion
CLEVIPREX® (clevidipine) Injectable Emulsion is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
IMPORTANT SAFETY INFORMATION
CLEVIPREX® (clevidipine) Injectable Emulsion is contraindicated in patients with:
- Allergies to soybeans, soy products, eggs, or egg products;
- Defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and
- Severe aortic stenosis.
CLEVIPREX is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration of CLEVIPREX. If either occurs, decrease the dose of CLEVIPREX. There is limited experience with short-duration therapy with beta-blockers as a treatment for CLEVIPREX-induced tachycardia. Beta-blocker use for this purpose is not recommended.
CLEVIPREX contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.
Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
CLEVIPREX is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.
Patients who receive prolonged CLEVIPREX infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.
There is no information to guide use of CLEVIPREX in treating hypertension associated with pheochromocytoma.
Most common adverse reactions for CLEVIPREX (>2%) are headache, nausea, and vomiting.
Please see complete prescribing information.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care, and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements 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" and “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 the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results 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 Quarterly Report on Form 10-Q filed with the SEC on August 4, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
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