• The American Red Cross and Blood Systems Incorporated (BSI) would be
the manufacturers of INTERCEPT plasma for treatment of TTP upon FDA
approval and could provide INTERCEPT plasma to other blood centers in
the US.
• Agreements facilitate controlled distribution of the treated plasma to
comply with FDA requirements, while simultaneously allowing broad access
to the TTP population via the nation’s two largest blood providers,
representing approximately 60% of the US supply.
• Cerus’ INTERCEPT pathogen inactivation technology is designed to
enhance safety against transfusion-transmitted infectious threats.
• INTERCEPT plasma has been granted orphan drug designation by the FDA
for treatment of TTP, a disease that places patients at heightened risk
for transfusion transmitted disease due to the considerable volumes of
plasma used in therapeutic exchange procedures.
CONCORD, Calif.--(BUSINESS WIRE)--
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.
http://www.bloodsystems.org/
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.
ABOUT CERUS
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.
Source: Cerus Corporation