Second U.S. Approval for Cerus’ INTERCEPT Blood System Extends
Pathogen Reduction to Platelet Components
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.
CONFERENCE CALL
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.
ABOUT CERUS
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.
Source: Cerus Corporation