Cerus Corporation CERS announced today that it has entered into
independent partnership agreements with both the American Red Cross and Blood
Systems Incorporated (BSI) to commercialize INTERCEPT plasma for use in the
orphan indication of thrombotic thrombocytopenic purpura (TTP) in the United
States.
TTP is a rare, life-threatening blood disorder that typically requires
transfusion with large volumes of plasma. There are an estimated 2,000-3,000
cases of TTP annually in the U.S. There are currently no drugs approved for
treatment of TTP, and episodes are associated with significant risk of
mortality from widespread blood clotting which restricts blood flow to
critical organs such as the brain, kidneys and heart. Over the course of TTP
treatment, a patient may receive in excess of 40 liters of plasma,
representing exposure to plasma units from more than 200 blood donors. Cerus'
INTERCEPT plasma was granted orphan drug designation for this indication last
year, and the company is currently in discussion with the US Food and Drug
Administration (FDA) to determine requirements for potential INTERCEPT plasma
approval to treat TTP in the US.
The Red Cross and BSI would be the US manufacturers of INTERCEPT plasma for
treatment of TTP. Manufacturing INTERCEPT plasma through these two blood
centers facilitates controlled distribution of the treated plasma to comply
with FDA requirements, while simultaneously allowing broad access to all blood
centers and hospitals supporting the TTP population.
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