Preliminary Data From Experimental Study Demonstrate Increased Mortality In Stroke Patients Treated With Epoetin Alfa

Ortho Biotech has become
aware of preliminary data from an investigator-initiated experimental study
of the effects of Epoetin alfa in patients with acute ischemic stroke. In
this study, patients suffering acute ischemic stroke who were treated with
Epoetin alfa within six hours of the onset of stroke symptoms died more
frequently than patients receiving placebo. Ortho Biotech has reported this
information to the U.S. Food and Drug Administration and to European
regulatory authorities. Additional analyses are underway to better
understand these preliminary results.



Epoetin alfa is marketed as EPREX(R) / ERYPO(R) outside the U.S. by
Janssen-Cilag, as PROCRIT(R) in the U.S. by Ortho Biotech and as EPOGEN(R)
in the U.S. by Amgen. None of these products are approved in any country
for use in patients with acute ischemic stroke. Epoetin alfa is a member of
the class of erythropoiesis-stimulating agents (ESAs). ESAs should be used
strictly in accordance with their approved indications and dosing
recommendations.



This investigator-initiated experimental study was designed and
conducted by an investigator in Europe. Ortho Biotech provided study drug
and funding, but the company had no role in designing or conducting the
study. The investigator has informed the company that the results of this
study will be submitted for publication promptly.


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