CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (Nasdaq:CERS) today announced that it has filed for CE
Mark registration for the Company’s INTERCEPT red blood cell (RBC)
system.
“The INTERCEPT RBC CE Mark submission is a major milestone in the
Company’s history and represents the culmination of years of effort to
complete the full INTERCEPT portfolio of products to help ensure that
patients have access to safe blood transfusions,” said William ‘Obi’
Greenman, the Company’s president and chief executive officer. “Red
blood cell transfusions are one of the most common hospital procedures
globally, and there are more than 25 million red blood cell units
transfused in Europe, Middle East and Africa (EMEA) annually. The
INTERCEPT red blood cell system is designed to reduce the risk of
transfusion transmitted infections and other potential complications
such as transfusion-associated graft-versus host disease.”
“The INTERCEPT red blood cell system is an important extension to our
portfolio and our existing blood center customers are excited about the
opportunity to potentially safeguard all three major blood components,”
continued Greenman. “We are looking forward to working with the
regulatory agencies in EMEA to bring this important product to market.”
Carol Moore, Cerus’ senior vice president of regulatory affairs and
quality, commented, “We anticipate the regulatory review process could
exceed 15 months given the breadth of the submission, which covers both
device and biologic elements. Our submission will be reviewed by TÜV
SÜD, our notified body, and Irish Health Products Regulatory Authority,
the competent authority.”
The CE Mark submission included a robust clinical dossier developed from
Cerus’ two European Phase 3 clinical studies, STARS and SPARC.
The STARS study was a randomized, double-blinded multicenter center
study evaluating the efficacy and safety of INTERCEPT RBC in acute
anemia patients. Red blood cell components were transfused to
cardiovascular surgery patients at two German clinical trial sites. The
study met the primary endpoint, which demonstrated that the mean
hemoglobin content of INTERCEPT-treated RBCs were equivalent to
conventional RBCs.
The SPARC study was a randomized, double blinded cross-over study
evaluating the efficacy and safety of INTERCEPT RBC in chronic anemia
patients. A total of 86 thalassemia patients were enrolled at three
participating international sites. Subjects were randomly assigned to a
sequential treatment period of either INTERCEPT-treated RBCs or
conventional RBCs with cross over to the other treatment arm upon
completion of the first treatment period. Each treatment period
consisted of 6 transfusion episodes. The study met the primary endpoint,
which was designed to assess up to a 15% relative difference in mean
consumption of hemoglobin, a measure of red blood cell efficacy and iron
burden.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood transfusion safety. The INTERCEPT Blood System is designed to
reduce the risk of transfusion-transmitted infections 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 of the INTERCEPT treatment is designed to inactivate established
transfusion threats, such as hepatitis B and C, HIV, West Nile virus and
bacteria, as well as emerging pathogens such as chikungunya, malaria and
dengue. 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.
Forward Looking Statements
Except for the historical statements contained herein, this press
release contains forward-looking statements concerning Cerus’ CE Mark
submission for the INTERCEPT red blood cell system, including the timing
of regulatory review and approval thereof. Actual results could differ
materially from these forward-looking statements as a result of certain
factors, including, without limitation, risks associated with the
uncertain and time-consuming regulatory process, including with respect
to the label claims ultimately approved for INTERCEPT red blood cell
system; that Cerus may be unable to obtain CE Mark approval, or any
other regulatory approvals, of INTERCEPT red blood cell system in a
timely manner or at all; that applicable regulatory authorities may
disagree with Cerus’ interpretations of the data from its clinical
studies and/or may otherwise determine not to approve Cerus’ regulatory
submissions in a timely manner or at all, as well as other risks
detailed in Cerus’ filings with the Securities and Exchange Commission,
including Cerus’ Quarterly Report on Form 10-Q for the quarter ended
September 30, 2018, filed with the SEC on November 1, 2018. Cerus
disclaims any obligation or undertaking to update or revise any
forward-looking statements contained in this press release.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20181218005231/en/
Tim Lee – Investor Relations Director
Cerus Corporation
925-288-6137
Source: Cerus Corporation