Medicines Co's Cangrelor clearly tops Plavix in pivotal trial

Sun Mar 10, 2013 1:01pm EDT

* Cangrelor reduced serious heart risk by 22 pct vs Plavix
    * Reduces clots in heart stents by 38 percent
    * Serious bleeding very low for both drugs

    By Bill Berkrot
    SAN FRANCISCO, March 10, (Reuters) - The Medicines Co's
 experimental intravenous blood clot preventer
Cangrelor, which is intended for use during angioplasty
procedures, solidly outperformed commonly used Plavix in a
pivotal late stage study, likely resurrecting the drug's
prospects.
    The aptly named Champion-Phoenix trial, with 11,000 patients
undergoing an angioplasty and stenting procedure, was meant to
save the potentially important new medicine from the ashes of a
pair of prior Phase III studies in which it failed to achieve
the primary goal.
    The third time around, with some trial design changes aimed
at more accurately reflecting heart attacks likely associated
with the drugs and not the procedure, appears to have been the
charm. The company had previously announced that the third study
succeeded, but the details were released at the American College
of Cardiology scientific meeting in San Francisco on Sunday.
    The primary goal was a combination of death, heart attack,
need for repeat procedures or stent thrombosis, a blood clot
forming at the site of the stent, at 48 hours after the
procedure. The percentage of patients who suffered one of those
serious complications was 4.7 for cangrelor and 5.9 for Plavix,
now available generically as clopidogrel. The result, which was
statistically significant, represented a 22 percent risk
reduction for the Medicines Co drug.
    "I think it's a significant advance in the care of patients
undergoing stent procedures, which of course is one of the most
common procedures in the U.S. and worldwide," Dr. Deepak Bhatt,
a co-lead investigator of the study, said in an interview. "I
think the potential health impact of our findings are
substantial and I hope that the result will help change clinical
practice."
    Cangrelor also showed a 38 percent reduction in stent
thrombosis alone, a key secondary goal of the study.
    Both drugs had very low and similar incidence of severe
bleeding - 0.16 percent for Cangrelor and 0.11 percent Plavix.
    Cangrelor has significant clinical advantages over Plavix
and other oral blood clot preventers in that it takes effect
rapidly and leaves the system in only one hour. The other drugs
continue to work for five days or more, which significantly
increases serious bleeding risk if a patient needs an emergency
or urgent follow-up procedure. In some cases, surgery will be
postponed for several days until the oral drug wears off.
    Cangrelor also would benefit patients unable to swallow
pills, researchers said.
    "The first two trials we thought provided very strong
signals of benefit," said Bhatt, chief of cardiology at the VA
Boston Health Care system and professor of medicine at Harvard
Medical School. 
    Noting a similar important reduction in stent thrombosis in
the earlier trials, he said, "That gave us confidence that there
really was some benefit to the drug, and that's why we launched
the third trial."
    The Phoenix trial included a broad cross section of patients
with conditions that require artery clearing intervention.
    "The results really do apply to a substantial percentage of
patients undergoing stent procedures around the world," Bhatt
said, calling the data "compelling."
    Medicines Co plans to file its application seeking U.S.
approval of Cangrelor in the second quarter.
    "If Cangrelor is approved, we think it will be a significant
 step forward for patients with cardiovascular disease in an
acute setting," said Simona Skerjanec, the company's head of
anti platelet therapies.
    Adnan Butt, an analyst with RBC Capital Markets, is
estimating Cangrelor to attain peak sales of about $400 million
by 2019.
A couple walks along the rough surf during sunset at Oahu's North Shore, December 26, 2013. REUTERS/Kevin Lamarque

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