CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) today announced that the U.S. Food and Drug Administration (FDA) has approved the INTERCEPT Blood System for platelets. The INTERCEPT platelet system is approved for ex vivo preparation of pathogen-reduced apheresis platelet components in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and to potentially reduce the risk of transfusion-associated graft versus host disease (TA-GVHD).
The approval marks the first time that a system to inactivate pathogens in platelet components will be available in the United States. The FDA approved the INTERCEPT Blood System for plasma on December 16. The INTERCEPT systems for both plasma and platelets use the same illumination device, the same active compound (amotosalen) and very similar production steps.
“The synergy and broad utility of the INTERCEPT Blood System as a single platform for pathogen reduction of both platelet and plasma components has been proven through many years of routine use in Europe, and will now be available to blood centers in the U.S.,” said William “Obi” Greenman, Cerus’ president and chief executive officer. “Transmission of pathogens via blood transfusion remains an ongoing threat, and we believe that relying on tests or donor deferrals is no longer enough. The recent INTERCEPT approvals will allow blood centers to take a more proactive step toward reducing the infectious risk from a platelet or plasma transfusion.”
Platelets are the first line of defense to prevent and treat small blood vessel bleeding, and platelet transfusion is an effective supportive therapy for patients with a low platelet count or non-functioning platelets due to a broad range of conditions including cancer, chemotherapy, or surgical procedures. Despite 10 years of efforts to improve bacterial culture testing, bacterial contamination of platelet components is the second most common cause of transfusion related death in the U.S. In contrast, eight years of INTERCEPT experience in France and four years of experience in Switzerland have demonstrated protection from bacterial contamination of platelet components.
While current screening tests for a limited number of pathogens have lowered the risks from transfusion-transmitted infections, these tests are reactive approaches, requiring identification of specific pathogens for which tests can then be developed and implemented. In contrast, pathogen reduction by inactivation is a proactive safety measure-- the process can inactivate susceptible viruses, bacteria, and parasites present in platelet components independently of whether they have been identified as specific blood supply risks. This is critical because there is typically a lag between the emergence of new pathogens, and the recognition that an additional safety intervention may be needed.
As the recent chikungunya, dengue fever and Ebola outbreaks have demonstrated, pathogens continually emerge and present an ongoing threat to public health. The INTERCEPT platelet system was recently made available in the U.S. under an Investigational Device Exemption (IDE) study to reduce the risk of transfusion-transmitted dengue and chikungunya viruses, both of which are epidemic in the Caribbean region, including Puerto Rico, as well as sporadically in the Southern United States. No approved blood bank screening tests are available for either virus.
"In Europe, INTERCEPT's capacity to inactivate a broad spectrum of viruses, bacteria, parasites and leukocytes has allowed blood centers to replace some of the safety methods currently used to prepare platelet components," said Dr. Laurence Corash, chief medical officer and scientific officer of Cerus. "We look forward to working with the FDA, the AABB and blood centers to define what safety methods may be impacted by INTERCEPT use in the United States."
Platelets, plasma and red blood cells do not require functional DNA or RNA for therapeutic efficacy. However, pathogens (bacteria, viruses and parasites) and white blood cells do require replication of these nucleic acids in order to transmit infection. The INTERCEPT Blood System targets this basic biological difference between the therapeutic components of blood, compared to pathogens and donor white blood cells. The system uses a proprietary molecule that when activated by UVA light, binds to and blocks the replication of DNA and RNA, preventing nucleic acid replication and rendering the pathogen inactive.
The INTERCEPT Blood System for platelets has been approved in Europe since 2002 and is currently used in over 100 blood centers in 20 countries.
Cerus will host a conference call and webcast on Friday, December 19 at 8:30 AM ET to discuss the U.S. approval for INTERCEPT platelets. To access the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international).
A replay will be available on the company’s web site, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 56479261. The replay will be available approximately three hours after the call through January 2, 2014.
ABOUT THE INTERCEPT BLOOD SYSTEM FOR PLATELETS
The INTERCEPT Blood System for platelets is comprised of single-use platelet processing sets and an ultraviolet (UVA) illumination device for the ex vivo preparation and storage of pathogen-reduced apheresis platelet components. The safety and efficacy of INTERCEPT processed platelets has been evaluated in 10 controlled clinical studies, with over 800 study subjects. Routine use of INTERCEPT processed platelets has been monitored in over 4000 patients in an active hemovigilance studies conducted by Cerus in Europe, and additionally through national hemovigilance reporting systems in France (since 2009) and Switzerland (since 2010). For U.S. product information, see http://www.intercept-usa.com.
Cerus Corporation is a biomedical products company focused in the field of blood safety. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, 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 information about Cerus.
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 commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System for platelets and plasma by U.S. blood centers, and the ability of INTERCEPT platelets to effectively address transfusion associated events, lower blood center operating costs, improve blood center operations, and to replace currently used safety methods. 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 related to broad market adoption of the INTERCEPT Blood System and budgetary, operational and technical challenges that U.S. blood centers may face in adopting Cerus’ products, Cerus’ limited resources and experience expanding commercialization of its products to new geographies and markets, FDA’s willingness to allow the INTERCEPT Blood System to replace current safety methods, and other risks detailed in Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' quarterly report on Form 10-Q for the quarter ended September 30, 2014, filed with the SEC on November 7, 2014. 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.