Data on Angiox (Bivalirudin Injection) in Heart Attack Patients Presented at EuroPCR and Published in European Heart Journal

  Data on Angiox (Bivalirudin Injection) in Heart Attack Patients Presented at
  EuroPCR and Published in European Heart Journal

Business Wire

PARIS -- May 22, 2014

During the Late Breaking Clinical Trial sessions at EuroPCR yesterday and
published simultaneously in the European Heart Journal, Professor Uwe Zeymer
of Klinikum Ludwigshafen, Ludwigshafen, Germany and others reported a paper
entitled: “Bivalirudin is superior to heparins alone with bailout GP IIb/IIIa
inhibitors in patients with ST-segment elevation myocardial infarction
transported emergently for primary percutaneous coronary intervention: a
pre-specified analysis from the EUROMAX trial”.

The EUROMAX trial studied 2,198 patients with heart attacks (STEMI) during
their transport on the way to urgent heart procedures (PPCI) aimed at
unblocking coronary arteries occluded by blood clots – the underlying cause of
heart attacks. Treatment with bivalirudin (Angiox) was compared to heparin or
low-molecular weight heparin (heparins) given with optional glycoprotein
inhibitors (GPI). As reported in The New England Journal of Medicine last
year, the trial met all of its pre-specified endpoints.

Lead author and presenter of the new analysis Dr Uwe Zeymer MD, of Klinikum
Ludwigshafen, Ludwigshafen, Germany said, ‘’The results of this pre-specified
subgroup analysis are consistent with the overall trial results. Bivalirudin
resulted in significantly lower rates of the primary outcome and major
bleeding regardless of routine or bailout only use of GPI.”

Principal investigator of the EUROMAX trial Professor P. Gabriel Steg, MD, of
Hôpital Bichat in Paris said, "The results of this pre-specified subgroup
analysis are in keeping with the overall trial results and provide evidence
that the reductions in the primary endpoint and protocol major bleeding seen
with bivalirudin over heparin are consistent regardless of the use of GPI.
However, the 1% absolute increase in acute stent thrombosis observed in the
overall EUROMAX trial was also seen in this pre-specified analysis.”

About Angiox/Angiomax

In the United States, bivalirudin is marketed under the trade name Angiomax®
and is indicated in patients undergoing PCI with provisional use of GPI and in
patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis
syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated
for use as an anticoagulant in patients with UA undergoing percutaneous
transluminal coronary angioplasty (PTCA). Angiomax is intended for use with
aspirin. Angiomax is not approved for use in patients with acute coronary
syndromes (ACS) not undergoing PCI or PTCA. Please see full prescribing
information for Angiomax, available at http://www.angiomax.com.

In Europe, bivalirudin is marketed under the trade name Angiox® and is
indicated as an anticoagulant for adult patients undergoing PCI, including
patients with STEMI undergoing primary PCI. Angiox is also indicated for the
treatment of adult patients with unstable angina/non-ST segment elevation MI
planned for urgent or early intervention. Please see full prescribing
information available at http://www.angiox.com.

In clinical trials comparing Angiomax and heparin, the most common adverse
reaction for Angiomax was bleeding (28%). Other common adverse reactions were
headache, thrombocytopenia and fever. 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
should be used with caution in patients with disease states associated with an
increased risk of bleeding.

In gamma brachytherapy, an increased risk of thrombus formation, including
fatal outcomes, has been associated with the use of Angiomax. Angiomax is
contraindicated in patients with active major bleeding or hypersensitivity to
Angiomax or its components.

About EUROMAX

EUROMAX (EUROpean aMbulance Acs angioX trial) was a 2,218 randomized,
controlled, open label, international, multicenter study that compared early
administration of bivalirudin, which is marketed as Angiox in the European
Union, and Angiomax in the US, to heparins with or without glycoprotein
inhibitors (GPI). Patients with ST-segment elevation myocardial infarction
(STEMI) who were being transported for primary PCI received either bivalirudin
or unfractionated or low-molecular-weight heparin with optional GPI (control
group). At 30 days, the primary outcome was a composite of death or major
bleeding not associated with coronary-artery bypass grafting (CABG), and the
principal secondary outcome was a composite of death, reinfarction, or
non-CABG major bleeding. Patients who were assigned to the bivalirudin group
received a bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg
per kilogram per hour, which should be continued for at least 4 hours after
PCI. The protocol also specified that the dose during the post-PCI interval
should be 0.25 mg per kilogram per hour; however, continuation of the higher
dose used during PCI was also permitted. Bailout use of a GPI was allowed in
the event of giant thrombus or no-reflow.

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