Yeehaw time for MDCO. See the below. This stock is ready over the next year for a absolute huge run. Keep this two bagger for the fun ride.
Study Published in Journal of the American Medical Association Validates Angiomax -Bivalirudin- as a New Standard of Care for Angioplasty Treatment
Tuesday February 18, 4:01 pm ET
PARSIPPANY, N.J.--(BUSINESS WIRE)--Feb. 18, 2003--Results of REPLACE-2, one of the largest angioplasty clinical trials ever conducted, are published in the February 19, 2003 issue of The Journal of the American Medical Association, The Medicines Company (Nasdaq: MDCO - News) announced today.
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Results of REPLACE-2 validate the Company's Angiomax® (bivalirudin) anticoagulant as a new standard of care for coronary angioplasty, a procedure conducted on more than one million Americans annually, to clear restricted blood flow in coronary arteries. Angiomax, a synthetic product approved for use in 2001, is marketed as a replacement for heparin in coronary angioplasty. Heparin is a product discovered in 1916 that is manufactured from by-products of cow lungs or pig intestines and carries multiple clinical and practical limitations.
REPLACE-2 results demonstrate that an anticoagulant regimen built on Angiomax, with provisional use (7.2 % of patients) of intravenous platelet blockers known as GP IIb/IIIa inhibitors is superior to heparin alone for both efficacy and safety. Similarly, when the regimen built on Angiomax was compared to a study arm that included heparin plus GP IIb/IIIa inhibitors, the best available care of today, the Angiomax arm was found to be as effective, while easier to use, safer and less costly.
"REPLACE-2 results support the clinical transition from heparin to bivalirudin as the foundation anticoagulant in coronary angioplasty," stated A. Michael Lincoff, M.D., Associate Professor at The Cleveland Clinic, and lead author of the study. "There is virtually no justification at all for using heparin alone for the types of patients treated in REPLACE-2. The bivalirudin with provisional GP IIb/IIIa blockade demonstrates comparable efficacy to the current gold standard, with the added attraction of lower cost, less bleeding and greater ease of administration."
Eric J. Topol, M.D., Chairman of Cardiovascular Medicine at The Cleveland Clinic, and Chairman of the study's steering committee added, "This trial is noteworthy due to its size, its relevance and its results, which for the first time validate a new and highly practical strategy of improved anticoagulation (with bivalirudin) even in an era in which we have greatly improved our therapy directed against platelets."
Detailed results of REPLACE-2 highlight advantages associated with the use of Angiomax:
Significantly Enhanced Treatment Efficiency/Ease of Use
The average duration of Angiomax infusion was 44 minutes vs. the 12-18 hour infusion indicated for the GP IIb/IIIa inhibitors used in the heparin arm
97% of patients achieve anticoagulant targets from initial injections of Angiomax vs. only 88% of heparin treated patients
Reduced Cost
Per-patient pharmacy acquisition cost find greater than $400 per-patient reduction in the Angiomax arm vs. the heparin arm (based on the average wholesale costs noted in the JAMA publication)
Superior Safety
41% reduction in major bleeding Angiomax arm vs. heparin plus GP IIb/IIIa
32% reduction in transfusion Angiomax arm vs. heparin plus GP IIb/IIIa
59% reduction in thrombocytopenia (clinically significant reduction in the number of platelets), Angiomax arm vs. heparin plus GP IIb/IIIa
Gold-standard Efficacy
Angiomax was as effective as heparin plus GP IIb/IIIa inhibitors for "triple" ischemic composite endpoint of death, myocardial infarction, or urgent revascularization and superior to heparin alone
"The REPLACE-2 JAMA article provides a compelling story to interventional cardiologists," commented Dave Stack, President and Chief Executive Officer of The Medicines Company. "What we are hearing in the marketplace is that in addition to efficacy; ease of use, safety, and cost are all important issues to the physician and patient. With the pending launch of drug-eluting stents expected to increase the number of angioplasty procedures performed and the potential for outpatient angioplasty, Angiomax is poised to address important and relevant issues in contemporary angioplasty care."
Next Steps
The Medicines Company plans on submitting the REPLACE-2 data results to the U.S. Food and Drug Administration (FDA) as a supplemental NDA (sNDA) to update the Angiomax package insert to include the contemporary REPLACE-2 data. The Medicines Company and its European partner, Nycomed, will submit REPLACE-2 data as the basis of a Marketing Authorization Application (MAA) for approval to market in the European Union.
Additional subgroup analyses are also being performed, including the examination of different patient populations and combinations of the products used in the study. This information will be presented, along with a REPLACE-2 economic analysis, at a REPLACE-2 subset symposium scheduled for March 29, as part of the American College of Cardiology conference in Chicago.
REPLACE-2 Design
REPLACE-2 was a 6,002 patient (intent to treat), randomized, double-blind trial conducted at 233 clinical sites in the United States, Canada, Western Europe and Israel. The majority (77%) of patients were enrolled in the U.S. Patients received either heparin plus a GP IIb/IIIa inhibitor (either Integrilin® or Reopro®) or Angiomax with provisional use of a GP IIb/IIIa inhibitor.
Provisional use of GP IIb/IIIa inhibitors was at the discretion of the investigator and based on, but not limited to, a list of pre-defined clinical circumstances that suggested a need for additional therapy. It is important to note that the use of a provisional GP IIb/IIIa did not unblind the study drug. When the operator requested a provisional agent, patients in the heparin plus GP IIb/IIIa arm were administered a placebo, while patients in the Angiomax arm received a GP IIb/IIIa inhibitor.
About Angiomax
Angiomax was approved in the U.S. for use in coronary angioplasty in December of 2000 and was launched in the U.S. in January of 2001.
Angiomax is a small-molecule direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has shown a reduction in the incidence of death, myocardial infarction, and the need for revascularization in patients undergoing coronary angioplasty, as well as significant reductions in bleeding complications compared to heparin, or heparin plus a GP IIb/IIIa inhibitor in the contemporary cath. lab setting. These reductions in ischemic and bleeding complications are consistent and remain evident in high-risk patients unlike outcomes in high risk patients treated with heparin. Reductions in these complications not only represent the opportunity for better patient care, but also the opportunity for cost-savings.
Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
About The Medicines Company
The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve specialized care. The Company markets Angiomax® (bivalirudin), an anticoagulant approved in the United States and other countries for use in patients undergoing coronary angioplasty procedures. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is themedicinescompany.com.
This press release contains forward-looking statements of The Medicines Company that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "intends," and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Factors that May Affect Future Results" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2002 and incorporated herein by reference. These important factors include risks as to the commercial success of Angiomax; how long the Company will be able to operate on its existing capital resources; whether the Company's products (other than Angiomax for its approved indication) will advance in the clinical trials process, the timing of such clinical trials, and whether the clinical trial results will warrant continued product development; whether and when, if at all, the Company's products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies, and for which indications, and, if such products receive approval, whether they will be successfully marketed. We do not assume any obligation to update any forward-looking statements.
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Contact:
The Medicines Company
Michael Mitchell, 973/656-1616
investor.relations@themedco.com |
