Cerus Corporation (NASDAQ: 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.
“Improving the safety of the blood supply and seeking opportunities to manufacture new, value-added blood products are core to our mission at the Red Cross,” said Richard Feliciano, senior vice president of business development for the Red Cross. “INTERCEPT plasma for patients with TTP is a logical and beneficial extension of the therapeutic apheresis services that we offer to many hospitals across the country.”
“We believe that pathogen inactivation represents a potentially important advancement in the field of transfusion medicine,” said Pat Holt, executive vice president at BSI. “Securing the optimum safety for patients receiving very large quantities of blood components as part of TTP therapy is consistent with Blood Systems’ goal to ensure the availability of safe and effective blood products for patients who rely on them.”