Health Economic Data on The Medicines Company’s Infectious Disease and Cardiology Portfolios to be Presented at the 17th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
The Medicines Company (NASDAQ:MDCO) today announced that data from two health economics analyses will be presented at the 17th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) being held in Amsterdam, November 8-12. The abstracts involve analyses from two core areas of hospital focus for The Medicines Company: serious infectious disease care and acute cardiovascular care.
“The analyses we are presenting this week are planned to provide a basis for our hospital customers to measure the impact of introducing new solutions to their practice. This, in turn, serves a key part of The Medicines Company’s purpose, which is to contribute to the economic efficiencies of healthcare,” said Stephanie Plent, MD, Executive Vice President and Chief Value Officer for The Medicines Company.
ORBACTIVTM (oritavancin) Data
- Abstract PSS10: A US HOSPITAL ECONOMIC IMPACT MODEL FOR ORITAVANCIN IN ABSSSI PATIENTS WITH RISK OF MRSA INFECTIONS: - Tuesday, 11 November, 15:30 – 19:30; Poster Author Discussion Hour: 18:30 – 19:30.
The study demonstrated that using ORBACTIVTM (oritavancin) instead of vancomycin in moderate-severe ABSSSI patients, including those at risk of MRSA, is estimated to deliver a potential cost reduction of $1,398/patient by shifting patient care to the observation/outpatient setting and decreasing resource utilization.
- Abstract PCV45: ESTIMATING THE VALUE OF CANGRELOR BY ELIMINATING PRELOADING IN CORONARY ARTERY BYPASS GRAFT (CABG) PATIENTS – Tuesday, 11 November, 15:30 – 19:30; Poster Author Discussion Hour: 12:30 – 13:30
This analysis was conducted to quantify the economic value that a US hospital could expect by using cangrelor and removing the need for P2Y12 pre-load prior to assessment of the patients’ anatomy. This study demonstrated that adoption of this strategy in patients with Coronary Artery Disease (CAD) undergoing PCI could enable hospitals to potentially realize $523 per CABG patient in economic value by avoiding the dilemma that exists when patients receiving oral P2Y12 therapy require CABG. Cost savings were derived by reducing the costs associated with bleeding and ischemic events, lowering washout drug costs and reducing hospitalization days.
The presentations emphasize The Medicines Company’s commitment to:
- Advancing awareness of the potential benefit of a long-acting antibiotic like ORBACTIVTM (oritavancin), the first and only antibiotic approved by FDA to treat adults with ABSSSIs caused or suspected to be caused by susceptible isolates of designated gram-positive organisms with a single, once-only intravenous administration.
- Reinforcing that cangrelor, an immediately bioavailable and quickly reversible intravenous small molecule investigational antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing PCI for whom oral P2Y12 therapy is not feasible or desirable.
About ORBACTIVTM (oritavancin)
ORBACTIVTM (oritavancin) for injection is indicated in the United States 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 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.
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing PCI.
The cangrelor NDA filing was based on the results of a development program which included the data from four randomized, double-blind clinical trials conducted in 25,567 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). The PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for cangrelor.
The results of CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company’s cangrelor to oral clopidogrel in patients undergoing PCI were reported in March 2013 and showed that patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization. Cangrelor also showed a 38% reduction in the odds of the key secondary endpoint, incidence of stent thrombosis at 48 hours. An increase in the incidence of access site bleeding and transient dyspnea was observed with cangrelor.
In 2011, The Medicines Company also reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent that were at increased risk of thrombotic events following discontinuation of oral platelet inhibition prior to coronary artery bypass graft (CABG) surgery.
In April 2014, the FDA issued a Complete Response Letter for our NDA for cangrelor. For the PCI indication, the FDA stated that the NDA cannot be approved at the present time and the FDA suggested that we perform a series of clinical data analyses of the CHAMPION PHOENIX study, review certain processes regarding data management, and provide bioequivalence information on the clopidogrel clinical supplies for the CHAMPION trials. For the BRIDGE indication, the FDA concluded that a prospective, adequate and well-controlled study in which outcomes such as bleeding are studied, can result in the clinical data necessary to assess the benefit-risk relationship in this indication. The FDA also provided additional comments for us to address, stating that the comments are not currently approvability issues, but could affect labeling. We plan to resubmit an NDA for cangrelor by the end of 2014 with respect to the PCI indication.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational, and scientific organization with over 8600 members from 115 countries (and over 7500 members from ISPOR’s 73 Regional Chapters around the world). ISPOR strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health. To learn more about ISPOR, please visit: www.ispor.org. Media Contact: Danielle Mroz, MA, Director, Communications, ISPOR (email@example.com).
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.
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