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The positive opinion is based on results from the ACUITY trial of 13,819patients with ACS, which found that Angiox with or without a glycoproteinIIb/IIIa inhibitor (GPI) resulted in similar rates of ischemic clinicaloutcomes compared to standard therapy of heparin (unfractionated orenoxaparin) plus a GPI. Importantly, Angiox monotherapy was associated with47% less major bleeding compared to standard therapy. Of the patientsenrolled in ACUITY, 35% were treated at European hospitals.
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"The CHMP recommendation will accelerate our efforts to establish Angioxas the preferred anti-thrombotic strategy for patients who require PCI forcoronary artery disease in Europe," noted John Kelley, President and ChiefOperating Officer of The Medicines Company. "We believe the EuropeanCommission will approve expanded use of Angiox in ACS patients during thefirst quarter of 2008, which coincides with the expansion of our commercialoperations into major European markets."
The Medicines Company re-acquired rights to Angiox in Europe in July 2007.Since then, the Company has been expanding its European presence anddeveloping clinical and commercial plans for Angiox with input from Europeanthought leaders in cardiology, thrombosis and health economics. The Companyalso has been working on clinical trials and expert advisory activities inEurope for the Company's Phase III development compounds, cangrelor andCleviprex(TM) (clevidipine butyrate injectable emulsion). The Company iscreating the legal infrastructure to support operations in Europe, isestablishing supply chain capabilities for the territory, and has set up acentral office in Zurich, Switzerland. The Medicines Company marketsbivalirudin as Angiomax(R) in the United States.
The European Society of Cardiology (ESC) in June 2007 published guidelinesfor the treatment of ACS that recommend using Angiox in ACS patientsundergoing PCI. The Company estimates that more than one million PCIprocedures are performed annually in Europe.
The CHMP is the scientific committee of EMEA. The opinions of the CHMPgenerally serve as the basis for the European Commission approvals, which arevalid in all Member States of the European Union and the European EconomicArea.
In the United States, a similar Angiomax ACS filing is being reviewed bythe U.S. Food and Drug Administration (FDA). The Company expects FDA actionin mid-2008.
About ACUITY
ACUITY was one of the largest ACS clinical trials ever conducted toevaluate anti-thrombotic therapies and enrolled 13,819 high-risk patients in450 centers worldwide. The trial design employed an early invasive strategy(angiography within 72 hours), starting anti-clotting therapy when ACSpatients arrived at the emergency department and randomly assigning them totreatment with standard therapy of heparin (unfractionated or enoxaparin) plusGPI, Angiox plus GPI, or Angiox monotherapy. In the Angiox monotherapy group,selective use of GPI was permitted in limited circumstances and occurred inless than 10% of patients. Then, based on an evaluation in the cardiaccatheterization laboratory, patients were treated for ACS through medicalmanagement, bypass surge
