In mid-May 2009, The Medicines Company (MDCO) announced that an interim analysis review committee (IARC), along with the data safety monitoring board (DSMB), after conducting a review of the ongoing CHAMPION phase III program with Cangrelor, notified the company that the ongoing CHAMPION-PLATFORM program would not meet the primary endpoint of a persuasive evidence of clinical effectiveness that could serve as the basis for regulatory approval.The IARC DSMB noted that the phase III CHAMPION-PCI program, a nearly fully enrolled 9000 patient program testing Cangrelor vs. Plavix (clopidogrel) in a non-inferiority, all-cause mortality (MI or IDR) study in patients undergoing PCI would also fail to show a meaning clinical difference. Management noted that the bleeding risk seen in the CHAMPION program was similar between Cangrelor and clopidogrel, so the trials were not stopped due to safety concerns.The CHAMPION-PLATFORM program, initiated in October 2006, had ...

What Cangrelor Failure Means To Medicines Co.This morning, The Medicines Company (MDCO) announced that an interim analysis review committee (IARC), along with the data safety monitoring board (DSMB), after conducting a review of the ongoing CHAMPION phase III program with Cangrelor, notified the company that the ongoing CHAMPION-PLATFORM program would not meet the primary endpoint of a persuasive evidence of clinical effectiveness that could serve as the basis for regulatory approval.Management noted that the bleeding risk seen in the CHAMPION program was similar between Cangrelor and clopidogrel, so the trials were not stopped due to safety concerns.The CHAMPION-PLATFORM program, initiated in October 2006, had enrolled approximately 5300 of the 6400 patients, testing Cangrelor plus usual care (clopidogrel) vs. usual care alone in a non-inferiority study looking at all-cause mortality (myocardial infarction or ischemia driven revascularization) in patients undergoing percutaneous coronary intervention (PCI)....

The Medicines Company (MDCO) specializes in acute care hospital cardiology products. It acquires and develops products that are either in the later stages of clinical development or are already on the market.

Its lead product is Angiomax, an anticoagulant approved in the U.S. and other countries for use in patients undergoing coronary angioplasty procedures. Recent positive data from two trials, ACUITY and HORIZON, has helped boost Angiomax sales in the past few quarters. We think this trend will continue. We are also looking forward to the Cleviprex ramp and an interim analysis on phase III candidate, Cangrelor in 2009.

However, the recent deal to acquire Targanta (TARG) and its phase III candidate (oritavancin) is a distraction, in our opinion. We do not see oritavancin on the market until 2012 at best. As such, our rating is now Hold.

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