PMA-S includes submission for pathogen-reduced
cryoprecipitate-poor plasma
Cerus Corporation (Nasdaq:CERS) announced today that the Company
has submitted a pre-market approval supplement (PMA-S) to the FDA
for a pathogen reduced cryoprecipitated fibrinogen complex with
5-day post thaw storage. This product was previously granted FDA
breakthrough device designation based on the potential to improve
treatment of massive hemorrhage, a life-threatening medical
condition. Trauma is the leading cause of death in the U.S. for
people under 45 years of age and approximately 40% of the
fatalities are the result of bleeding or its consequence1,2.
“This is a major milestone in our corporate history,” said
William ‘Obi’ Greenman, Cerus’ president and chief executive
office. “Pathogen-reduced cryoprecipitated fibrinogen complex is
manufactured from FDA licensed INTERCEPT plasma. If approved by the
FDA, it would be our first therapeutic product candidate. It is
being developed specifically to provide a source of fibrinogen and
other coagulation factors to treat patients with massive
bleeding.”
Severely bleeding patients generally do not receive conventional
cryoprecipitate immediately on hospital admission in current
massive transfusion protocols or during in-hospital surgical
procedures with massive bleeding because it is stored frozen and
requires thawing before administration. Furthermore, if unused
within four to six hours of thawing, conventional cryoprecipitate
must be discarded due to concern for bacterial contamination, and
it is wasted3. The high wastage rates due to limited post thaw
storage has impeded early use of cryoprecipitate in the treatment
of massive hemorrhage, resulting in limited availability at many
hospitals.
Cerus’ pathogen-reduced cryoprecipitated fibrinogen complex is
designed to be stored for up to five days at room temperature after
thaw and to be provided in doses enabling greater ease of use. If
approved by the FDA, the room temperature storage would enable
hospitals with active trauma centers, major surgical programs, and
high-risk obstetric patients to maintain an inventory of thawed
pathogen-reduced cryoprecipitated fibrinogen complex. This would
allow for immediate availability while minimizing wastage rates due
to the longer post-thaw shelf life compared to conventional
cryoprecipitate.
“We believe our pathogen-reduced cryoprecipitated fibrinogen
complex, if approved, will provide physicians with a critically
important option to treat hemorrhaging patients more rapidly when
every second counts,” continued Greenman.
“The recent PMA approval for the INTERCEPT Blood System for
plasma with alternate plastic disposable kits serves as the basis
for our PMA supplement submission,” said Carol Moore, Cerus’ senior
vice president of regulatory affairs and quality. “Given the
180-day review process for PMA supplements, we could potentially
receive FDA approval for pathogen-reduced cryoprecipitated
fibrinogen complex by the end of this calendar year.”
By thawing INTERCEPT treated frozen plasma between 1° and 6° C
and separating the precipitated cold-insoluble proteins and the
supernatant, two distinct blood components are generated: pathogen
reduced cryoprecipitated fibrinogen complex, and pathogen reduced
cryoprecipitate-poor plasma. Both products are included in the
PMA-S submission.
Pathogen reduced cryoprecipitate-poor plasma has been submitted
for approval with an indication to treat thrombotic
thrombocytopenic purpura (TTP) and is usually administered by
therapeutic plasma exchange (TPE) which is the current practice
with conventional cryoprecipitate-poor plasma. TTP is an
auto-immune blood disorder which if left untreated has a 90%
mortality rate in which a critical enzyme (ADAMTS13) is depleted,
resulting in blood clots forming in small blood vessels throughout
a patient’s body, thereby blocking blood flow to vital organs4. TPE
for TTP is a highly effective therapy, but it requires repeated
exposures to large volumes of plasma or cryoprecipitate-poor
plasma. Pathogen reduced cryoprecipitate-poor plasma offers the
potential to reduce the risk of transfusion-transmitted infections
in TTP patients treated with TPE and contains less clot-forming
proteins than plasma.
U.S. Commercial Opportunity
In the U.S., trauma is the leading cause of death in individuals
under 45 years old and the third leading cause of death overall for
all ages1. Approximately 40% of deaths associated with trauma are
the result of bleeding or its consequence2. Acute bleeding in other
settings includes postpartum hemorrhage and cardiac surgery.
Cryoprecipitate is often administered to these patients as an
important source of fibrinogen replacement and bleeding
control.
According to the 2017 National Blood Collection and Utilization
Survey, the number of cryoprecipitate units distributed in the
United States between 2015 and 2017 increased by 16.1% to 2.16
million doses or an estimated 700,000+ gram equivalents of
fibrinogen.
1. National Vital Statistics Report, Vol. 68, No. 6.
https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_06-508.pdf
2. Curry N, Hopewell S, Doree C, Hyde C, Brohi K, Stanworth S.
The acute management of trauma hemorrhage: a systematic review of
randomized controlled trials. Crit Care. 2011;15(2):R92.
3. Ramirez-Arcos, S., C. Jenkins, et al. (2017). "Bacteria can
proliferate in thawed cryoprecipitate stored at room temperature
for longer than 4 h." Vox Sang. 2017; 112(5):477-479.
4. George, J. N. (2010). "How I treat patients with thrombotic
thrombocytopenic purpura: 2010." Blood 116: 4060 - 4069.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Based in Concord, California, our employees are
dedicated to deploying and supplying vital technologies and
pathogen-protected blood components for blood centers, hospitals
and ultimately patients who rely on safe blood. With the INTERCEPT
Blood System, we are focused on protecting patients by delivering
the full complement of reliable products and expertise for
transfusion medicine. Cerus develops and markets the INTERCEPT
Blood System and remains the only company in the blood transfusion
space to earn both CE Mark and FDA approval for pathogen reduction
of both platelet and plasma components. Cerus currently markets and
sells the INTERCEPT Blood System 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. For more information
about Cerus, visit www.cerus.com and follow us on LinkedIn.
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 related to the
recent filing of a PMA-S submission for pathogen
reduced-cryoprecipitated fibrinogen complex and pathogen reduced
cryoprecipitate-poor plasma, including anticipated regulatory
approval, and the timing and the potential claims thereof; and
other statements that are not historical facts. Actual results
could differ materially from these forward-looking statements as a
result of certain factors, including, without limitation, risks
related to the uncertain and time-consuming development and
regulatory process, including that Cerus may be unable to obtain
FDA approval in a timely manner or at all; risks with respect to
the label claims ultimately approved for pathogen reduced
cryoprecipitated fibrinogen complex and pathogen reduced
cryoprecipitate-poor plasma; risk that FDA may disagree with Cerus‘
interpretations of the data from its clinical studies, 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, 2020, filed with the SEC on May 5,
2020. In addition, to the extent that the COVID-19 pandemic
adversely affects Cerus’ business and financial results, it may
also have the effect of heightening many of the other risks and
uncertainties described above. Cerus disclaims any obligation or
undertaking to update or revise any forward-looking statements
contained in this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20200526005257/en/
Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
Media Contact: Dan Boyle W20 Communications dan@boylepr.com
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