Strategic biologics initiative expands Cerus’ product portfolio.
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today an agreement with the
Central California Blood Center (CCBC) in which CCBC will manufacture
pathogen-reduced cryoprecipitate (“cryo”) for the company.
Cryoprecipitate is a blood product derived from blood plasma and
contains coagulation factors VIII and XIII, fibrinogen, vWF, and
fibronectin. Cryo is used in the control of bleeding associated with
acquired fibrinogen deficiency. The current cryo products available
today have a short post-thaw shelf life that limits their availability
and contributes to significant wastage rates in the hospital setting.
“We are excited to be partnering with CCBC as we move forward on a new
strategic program to expand our product offerings to include INTERCEPT
cryoprecipitate,” noted William ‘Obi’ Greenman, Cerus’ president and CEO.
“Cryo is a natural extension to our current FDA-approved INTERCEPT Blood
System for Plasma. Following approval of a proposed premarket approval
(PMA) supplement, INTERCEPT Plasma may be further manufactured into
cryoprecipitate, for which we plan to seek an extended 5-day post-thaw
storage claim. Given today’s growing emphasis on, and use of,
coagulation monitoring and fibrinogen supplementation in improving
outcomes in acutely bleeding patients, an extended-storage cryo product
can potentially address an opportunity that we believe represents a
market larger than INTERCEPT Platelets in the U.S.,” Mr. Greenman
continued.
“We are very pleased to be working with the Cerus team in developing a
next-generation cryoprecipitate product. We recognize the unmet need in
the clinical community for a cryo product with an extended post-thaw
shelf life, given the challenges faced by hospital blood banks today in
regard to the high wastage rates associated with the short expiry of
conventional cryo,” noted Christopher Staub, incoming president and CEO
of CCBC.
U.S. Commercial Opportunity
In the U.S., trauma is the leading cause of death in individuals under
44 years old. In addition, major hemorrhage is the most common
preventable cause of death in trauma patients. Acute bleeding in other
settings includes postpartum hemorrhage and cardiac surgery.
Cryoprecipitate is recognized as an important source of fibrinogen
replacement for these bleeding patients, and its clinical utility in
treating major bleeding is evidenced by its inclusion in clinical
statements such as the European guideline on management of major
bleeding and coagulopathy, the American Society of Anesthesiologists
(ASA) practice guidelines for perioperative blood management, and the
Society of Cardiovascular Anesthesiologists (SCA) summary statement on
blood conservation and transfusion in cardiac surgery.
Based on the 2015 AABB Blood Survey and the 2015 National Blood
Collection & Utilization Survey, usage of conventional cryoprecipitate
has been growing at double digit rates over the last five years. In
addition, we believe the recent growth in next generation-coagulation
monitoring systems is indicative of the expanding market opportunity for
interventions to treat coagulopathy in cardiovascular surgery, trauma
and maternal hemorrhage.
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 www.cerus.com
for information about Cerus.
About Central California Blood Center
The Central California Blood Center provides blood and services to
patients who receive care at 30 hospitals and their network of
facilities in Fresno, Tulare, Madera, Kings and Mariposa Counties. 5,000
to 6,000 pints of blood must be collected per month to meet the needs of
patients in our Central Valley community.
Forward-Looking Statements
Except for the historical statements contained herein, this press
release contains forward-looking statements relating to the potential
submission of a PMA supplement to the FDA with respect to a
pathogen-reduced, extended-storage cryo product, including the potential
approval and future launch thereof, in the U.S., the intent to seen an
indication for a pathogen-reduced, extended-storage cryo product and the
potential market opportunity such a product will have in the U.S..
Actual results could differ materially from these forward-looking
statements as a result of certain factors, including, without
limitation: risks associated with the commercialization and market
acceptance of, and customer demand for a pathogen-reduced,
extended-storage cryo product, that Cerus may encounter unanticipated
difficulties in meeting the PMA supplement requirements, that the
FDA could require additional clinical data to support potential approval
and that if additional clinical development is required, it will require
funding that Cerus does not currently have, that the FDA may not approve
a pathogen-reduced cryo product or an extended storage indication, risks
associated with successfully launching a new commercial product, the
potential demand for a pathogen-reduced cryo product, adverse market and
economic conditions, 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 March 31, 2017, filed with
the SEC on May 4, 2017. Cerus disclaims any obligation or undertaking to
update or revise any forward-looking statements contained in this press
release.
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Source: Cerus Corporation