Cerus Corporation Provides Update on COVID-19 Related Activities
April 06 2020 - 8:30AM
Business Wire
Cerus Corporation (Nasdaq:CERS) today announced the Company’s
recent activities related to COVID-19 and efforts to ensure that
patients have readily available access to pathogen-reduced blood
components, including convalescent plasma.
“As the world endures the impact from the current COVID-19
pandemic, our focused mission of ensuring the availability and
safety of the world’s blood supply has never been more relevant.
The impact that this pandemic has had on the security of the supply
chains for our blood center and hospital customers is
unprecedented,” said William ‘Obi’ Greenman, Cerus’ president and
chief executive officer. “During this challenging time for our
customers, Cerus is focused on helping them maintain the safety and
availability of the blood supply, while also providing the
assistance they need with regard to standing up programs to produce
COVID-19 convalescent plasma in sufficient quantities given the
many hospital inquiries globally. We are highly focused on ensuring
patients have access to our products and on protecting the health
and safety of our employees and the communities in which we
operate. Our financial strength prepares us to navigate this
pandemic while continuing to execute on the business objectives to
support our long-term growth.”
Our commitment to blood providers, hospitals and, ultimately,
patients:
- Our global supply chain for the INTERCEPT platelet disposable
kits is currently intact and at this time, we are confident in our
ability to supply INTERCEPT disposable kits. In anticipation of
greater demand for INTERCEPT, we increased our inventory levels in
2019 and believe we have ample supply to meet our customers’
needs.
- Fresenius Kabi (FK), our primary manufacturing partner,
produces INTERCEPT disposable kits at a facility in France and is
classified as an essential business by the French Government. To
ensure employee safety and comply with local requirements for
social distancing, the FK team recently reconfigured production
workflow and the facility continues to produce kits. Going forward,
employee absenteeism, at the manufacturing site, is a potential
risk that could negatively impact monthly production.
- We and our key suppliers have enacted business continuity
measures which are currently in place and have allowed INTERCEPT
disposable kit production and business growth to remain unaffected.
However, our supply chain is not without vulnerabilities and should
the current COVID-19 situation persist beyond the summer or worsen
regionally or globally, our business could be adversely
impacted.
Our commitment to our employees and their families:
- The safety and well-being of our employees and their families
during the pandemic is a top priority. We have taken steps to
ensure their safety and minimize the risk of community transmission
to help reduce the rate of new infections. Headquartered in
Concord, California, we are part of current state-wide orders to
“shelter-in-place.” Globally, our offices and individual employees
are also operating under regional health environments that restrict
face-to-face interactions and movement. As a result, most of our
employees are working from home to maintain Cerus’ day-to-day
operations. However, we continue to work diligently to advance our
development portfolio and to expand the label claims and ease of
use of the INTERCEPT Blood System.
- Our field team is collaborating with our blood center and
hospital customers in new ways including the use of enabling
technology such as video conferencing for technical support and
training. In situations where our field team needs to be on-site,
we will take every necessary travel precaution to keep our
employees safe while ensuring our customers can continue to
manufacture INTERCEPT treated blood components.
Our commitment to our R&D programs and impact to clinical
trials and studies:
- Pathogen-reduced cryoprecipitate: Pathogen-reduced cryo
continues to be one of our highest priority R&D programs given
the expected clinical utility and potential benefit to patients.
For this FDA Breakthrough Device designated program, we do not
anticipate disruptions to our activities surrounding data
collection and regulatory submission. We continue to expect to file
our PMA supplement in the first half of the year.
- U.S. red blood cell (RBC) development program: As a result of
COVID-19, many of our participating clinical trial hospital sites
have suspended enrollment. In addition, three out of the four blood
center partners that produce pathogen-reduced RBCs for these
studies have suspended production because of the need to conserve
red blood cells to meet hospital demand during the pandemic. While
we plan to continue the study enrollment at the sites we can, we
will look to reinitiate enrollment at all study sites as quickly as
possible. In support of the planned U.S. regulatory filing, we
expect to initiate a study in sickle cell chronic exchange
transfusion in the U.K., although the timing has been impacted due
in part to the COVID-19 pandemic.
- European red blood cell regulatory status: The transition of
our CE mark submission from a medical device directive (MDD) filing
to a medical device regulation (MDR) filing as a result of the
change in European regulatory laws is expected in the second
quarter of 2020. However, a recent European Commission letter to
the European Parliament and European Council has proposed
postponing the MDR compliance date by a year to May of 2021, and it
is unknown at this time whether the CE mark submission will
continue its review under the MDD pathway or transition at some
later point to the MDR pathway.
- U.S. INTERCEPT plasma with DEHP-free plastic disposable kits:
The U.S. regulatory filing for INTERCEPT plasma with alternate
plastic kits was submitted to the FDA during the fourth quarter of
2019. We anticipate FDA approval during the second quarter of
2020.
- Efficacy of INTERCEPT to pathogen-reduce SARS-CoV-2: To date,
there have been no documented cases of COVID-19 as a result of
transfusion transmitted infections. However, SARS-CoV-2 has been
found in the serum of COVID-19 patients which raises concerns, even
though there is no historical evidence of respiratory viruses being
associated with transfusion transmitted infectious disease.
Building off of our previous studies demonstrating robust
inactivation of SARS and MERS in blood components, we are
conducting tests to assess the efficacy of INTERCEPT in
inactivating SARS-CoV-2. Results of these tests are anticipated in
mid-2020.
Our commitment to standing up coronavirus convalescent plasma
studies globally :
- In Europe, our deployment team is collaborating with, and
supporting blood centers and hospitals interested in processing
coronavirus convalescent plasma (CCP) to quickly implement systems
to enable blood centers to produce INTERCEPT treated CCP.
- With the aim of optimizing convalescent plasma therapy for
COVID-19 patients, Cerus has formed a collaborative research group
led by Dr. Laurence Corash, the Company’s chief scientific officer.
The research team seeks to define the key characteristics that
influence the potential efficacy of convalescent plasma, including
the level and nature of anti-COVID-19 antibodies, optimal
collection timing, dosing and how these influence responses to the
therapy regimen. The research collaboration also plans to explore
the further optimization of CCP treatment by pooling units to
standardize the antibody profile and by generating a lyophilized
product to facilitate ease of use and availability.
- In the U.S., we have developed tools and created standardized
protocols to support blood centers and hospitals to quickly
implement processes to produce INTERCEPT treated CCP.
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.
Forward Looking Statements
Except for the historical statements contained herein, this
press release contains forward-looking statements relating to: the
Company’s financial strength to continue its business objectives to
support long-term growth; the sufficiency of the Company’s business
continuity measures to maintain supply of products and ensure
production remains unaffected; the therapeutic benefits of
pathogen-reduced cryoprecipitate; submission of the Company’s PMA
supplement for pathogen-reduced cryoprecipitate; expected timing
and delays in enrollment for the Company’s RBC clinical trials;
expected timing for initiation of the Company’s sickle cell study
in the U.K.; the timing for CE mark submission for the RBC System
under the Medical Device Regulation; expected FDA approval of the
plasma disposable kits using DEHP-free plastics; the timing and
results of the inactivation studies of SARS-CoV-2; and the
optimization of CCP treatment and availability of lyophilized CCP.
Actual results could differ materially from these forward-looking
statements as a result of certain factors, including, without
limitation risks related to the uncertainty of Cerus’ future
capital requirements and its future revenues and other financial
performance and results; Cerus’ ability to maintain an effective,
secure manufacturing supply chain; the uncertain and time-consuming
regulatory process, including the risks (a) that Cerus may be
unable to submit its planned PMA supplement to the FDA for
pathogen-reduced cryoprecipitate in a timely manner or at all, and
even if submitted, such planned PMA supplement may not be accepted
or approved in a timely manner or at all and (b) that Cerus may be
unable to submit its planned CE Mark application for the RBC System
under the Medical Device Regulation in a timely manner or at all,
and even if submitted, such planned CE Mark application may not be
accepted or approved in a timely manner or at all; the uncertain
and time-consuming development process, including the risks that
the INTERCEPT Blood System may not inactivate SARS-CoV-2; that
anticipated clinical trials of the INTERCEPT Blood System may not
be initiated on the anticipated timing or at all, or if initiated,
may be extended, delayed, suspended or terminated, including as
result of safety concerns; as well as other risks detailed in
Cerus’ filings with the Securities and Exchange Commission,
including Cerus’ Annual Report on Form 10-K for the year ended
December 31, 2019, filed with the SEC on February 21, 2020. To the
extent the COVID-19 pandemic adversely affects our 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. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press
release.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
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version on businesswire.com: https://www.businesswire.com/news/home/20200406005240/en/
Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
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