( arableclinical outcomes compared to st...)Acuity One-Year Findings Meet All Primary Endpoints in Favor of,Angiomax (Bivalirudin) Alone Treatment Group,Health

    * Death occurred in 3.8%, 4.2% and 4.4% of patients.  There was an

      observed numerical reduction (p=NS) in late mortality (after one month

      to one year) in the Angoimax alone treatment group, and


    * Composite ischemia events occurred in 16.4%, 16.5% and 16.3% of

      patients. Composite ischemia was defined as death, heart attack or

      unplanned revascularization for ischemia.

"We believe the one-year ACUITY results further substantiate Angiomax as a cornerstone therapy for the treatment of patients with ACS and add new information on treatment started in the emergency department to the wealth of data in the cardiac cath lab," said John Kelley, President and Chief Operating Officer of The Medicines Company. He said that MDCO anticipates submitting an sNDA for Angiomax for use in the treatment of patients with emergency ACS in the third quarter of 2007.

Additionally, the study found that major bleeding within 30 days following treatment increased the risk of death within one year even more than did a heart attack. The death rate among patients who suffered major bleeding compared to those who had a heart attack or neither was 12.5% vs. 8.6% vs. 3.4%, respectively. After adjusting for other variables, the risk of death for patients who had a major bleed or heart attack within 30 days following treatment was 2.89 and 2.47 times greater, respectively, than the risk for patients who did not experience either (p < 0.0001 for both comparisons).

"While heart attacks tend to happen in the hospital, we found the risk of death associated with major bleeding continues long-term," said Dr. Stone. "This makes major bleeding an even more powerful predictor of death than having a heart attack."

About ACUITY

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