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.”
Under the terms of the agreements, if INTERCEPT plasma is approved by the FDA, Cerus would provide INTERCEPT kits to BSI and the Red Cross and recoup the kit price from the final sale of the INTERCEPT plasma products. Collection and preparation of the INTERCEPT plasma would be performed by BSI and the Red Cross.
“The Red Cross and Blood Systems are two of the world’s preeminent blood centers, together producing approximately 60 percent of the US blood supply,” said William ‘Obi’ Greenman, Cerus’ president and CEO. “With the support of these two great partners in addition to this new business model for commercializing INTERCEPT treated blood components, we believe that we are well positioned for a successful US launch pending FDA approval of the INTERCEPT plasma system.”
In 2004, Cerus completed a phase 3 study of 35 TTP patients in which more than 3,500 units of INTERCEPT plasma were transfused. The primary endpoint of the trial, comparing the proportion of patients in the test and control groups achieving remission within 30 days after the first therapeutic plasma exchange, was met (82% of test patients achieving remission vs. 89% of patients in the control group). All secondary efficacy endpoints, comparing time to first remission, relapse rates and plasma exchange volume, were also met. The results of this study were published in the journal Transfusion in 2006 (Mintz et al. Transfusion 2006;46:1693-1704). INTERCEPT plasma is currently approved in Europe for use in all indications of plasma for transfusion, including treatment of TTP.
ABOUT BLOOD SYSTEMS
Founded in 1943 as the Salt River Valley Blood Bank in Phoenix, Arizona, Blood Systems is one of the nation’s oldest and largest blood service providers. The Company’s non-profit community blood centers, United Blood Services, Blood Centers of the Pacific and Inland Northwest Blood Center, provide blood, blood components and special services to patients in more than 500 hospitals in 18 states. Its Creative Testing Solutions unit specializes in high volume blood donor testing and infectious disease reference work. Blood Systems also focuses on transfusion medicine research within its Blood Systems Research Institute, as well as the distribution of therapeutic biologicals and recombinant coagulation factors via its BioCARE division. Blood Systems Laboratories specializes in immunohematology, functioning as the major reference laboratory for transfusion-related compatibility issues for blood centers and hospitals in various parts of the country.
ABOUT THE AMERICAN RED CROSS
The American Red Cross shelters, feeds and provides emotional support to victims of disasters, supplies more than 40 percent of the nation's blood, teaches skills that save lives, provides international humanitarian aid, and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. For more information, please visit redcross.org or join our blog at http://blog.redcross.org.
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT red blood cell system is in clinical development. See http://www.cerus.com for more information.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements relating to the potential launch and commercialization of, and potential approval by the FDA of, INTERCEPT-treated plasma to treat TTP, potential orphan drug exclusivity for INTERCEPT-treated plasma to treat TTP if approved by the FDA, the commercial potential for INTERCEPT-treated plasma to treat TTP, and Cerus’ expectations regarding the success and significance of the BSI and American Red Cross partnerships. These forward-looking statements are based upon Cerus’ current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the uncertain, costly and time-consuming product development process, risks associated with obtaining FDA regulatory approval for INTERCEPT-treated plasma, risks related to the commercial prospects for INTERCEPT-treated plasma, the risks that Cerus, the American Red Cross and BSI may not fulfill their respective obligations under the partnership agreements or that the partnership agreements may not be maintained, risks related to Cerus’ need for additional capital, including the risk that the sufficient additional funding Cerus requires for the further development of INTERCEPT-treated plasma for approval in the US may not be obtained, and other risks detailed in the Cerus' filings with, the Securities and Exchange Commission (SEC), including in Cerus' annual report on Form 10-Q for the quarter ended June 30, 2012, filed with the SEC on August 8, 2012. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Cerus does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.