The Medicines Company Infectious Disease Portfolio Data to Be Presented at ID Week 2014
The Medicines Company (NASDAQ:MDCO) today announced that data from its infectious disease portfolio will be presented at ID Week 2014, October 8-12 in Philadelphia, Pennsylvania.
The Medicines Company continues to focus on developing solutions for infections caused by pathogens that Centers for Disease Control and others around the world consider to be serious threats to global health, said Dr. Michael Dudley, Senior Vice President and Head of Health Science in the Infectious Disease Global Innovation Group. We are excited to present additional analyses of ORBACTIV (oritavancin) for injection, as well as new clinical and nonclinical data regarding the investigational intravenous antibiotic, CARBAVANCE (meropenem/RPX7009), underscoring the Companys commitment to supporting research and development of potential treatments for infections that pose a significant risk to society and healthcare systems globally.
The presentations emphasize The Medicines Companys commitment to:
- Raising awareness that infections by antibiotic-resistant super bugs remain an unacceptable threat to global health.
- Make available ORBACTIV, the first and only FDA-approved single dose treatment for adults with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of designated gram-positive pathogens. ORBACTIV is the first of a portfolio of antibiotics that have the potential to contribute to the economics of healthcare by addressing the critical medical need of treating MRSA, an antibiotic-resistant Gram-positive super bug.
- Developing and providing value-based solutions to the rising public health crisis, including a series of programs to combat multidrug-resistant Gram-negative infections: Minocin for acinetobacter; CARBAVANCE (meropenem/RPX7009), an investigational agent not approved for commercial use in any market being developed to treat serious Gram-negative infections, including those infections caused by bacteria resistant to currently available carbapenems; and a series of other innovative beta-lactamase inhibitor projects.
A total of six presentations will be featured during the meeting, including additional data from the SOLO I & II studies, the pivotal trials for ORBACTIV. In addition, in vitro, safety and tolerability studies of beta-lactamase inhibitor RPX7009 alone and in combination with meropenem (CARBAVANCE) will be presented, as well as an analysis comparing hospital costs associated with MDR vs. non-MDR Acinetobacter infections.
- Abstract 470: Oritavancin Activity Against Gram-positive Clinical Isolates Responsible for Documented Skin and Skin Structure Infections in USA and European Hospitals (2012-2013) – Thursday, October 9, 2014 from 12:30 p.m. to 2:00 p.m.
- Abstract 685: Time to Onset and Duration of Adverse Events in Patients with Acute Bacterial Skin and Skin Structure Infections Treated with Oritavancin The SOLO Studies – Friday, October 10, 2014 from 12:30 p.m. to 2:00 p.m.
- Abstract 1331: The SOLO Studies: A Single-Dose of Oritavancin (ORI) Compared to 7-10 Days of Vancomycin (VAN) in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) - Saturday, October 11, 2014 from 10:30 a.m. to 11:45 a.m.
- Abstract 257: In Vitro Activity of Meropenem/RPX7009, a Carbapenem/-lactamase Inhibitor Combination Tested Against Contemporary Populations of Enterobacteriaceae and KPC-producing Strains – Thursday, October 9, 2014 from 12:30 p.m. to 2:00 p.m.
- Abstract 401: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the Beta-lactamase inhibitor RPX7009 Alone, Meropenem Alone, and both in Combination (CARBAVANCE) TID for 7 days in Healthy Adult Subjects - Thursday, October 9, 2014 from 12:30 p.m. to 2:00 p.m.
Hospital Costs & MDR
- Abstract 338: Prevalence, Mortality and Outcomes of Antibiotic Therapy of Multi-Drug Resistant Acinetobacter baumannii – Thursday, October 9, 2014 from 12:30 p.m. to 2:00 p.m.
Abstracts for presentations are available for viewing on the ID Week 2014 website: http://www.idweek.org.
About The Medicines Company Infectious Disease Portfolio
The Medicines Company is taking on the complex problems associated with multi-drug resistant infections. The R&D 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(R) (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 ORBACTIV (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 methicillinresistant 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 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(R) IV (minocycline for injection)
MINOCIN(R) IV (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 CARBAVANCE (meropenem/RPX7009)
CARBAVANCE, an investigational agent not approved for commercial use in any market, is a combination of meropenem and RPX7009 being developed to treat serious Gram-negative infections, such as cUTIs, including those infections caused by bacteria resistant to currently available carbapenems.
CARBAVANCE was designed to address Gram-negative bacteria resistant to carbapenems that produce new beta-lactamase enzymes that have spread in the US 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 US and are classified by the CDC to be an urgent antimicrobial resistance threat.
The FDA has designated CARBAVANCE as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides CARBAVANCE priority review by the FDA, eligibility for the FDA’s “fast track” status, and an additional five years of any non-patent exclusivity upon approval of the product for intravenous use in six indications. These include complicated urinary tract and intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, and febrile neutropenia. The QIDP designation was granted pursuant to the Generating Antibiotic Incentives Now (GAIN) Act, included in the FDA Safety and Innovation Act (FDASIA) that was signed into law in 2012.
About ID Week
IDWeek 2014 is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS). With the theme Advancing Science, Improving Care, IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2014 takes place October 8-12 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania. The full name of the meeting is IDWeek 2014. For more information, visit www.idweek.org.
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 the extent of the commercial success of the Companys products, the Company’s ability to develop its global operations and penetrate foreign markets, 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.
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