Manufacturer of PAS No Longer Anticipates Future Shortage
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that the expected
Fresenius Kabi platelet additive solution (PAS) shortage the company
announced on May 23, 2017, could be less disruptive to blood center
production of INTERCEPT platelets than initially anticipated.
This follows a decision by the FDA to review a recent submission by
Fresenius Kabi as a Changes Being Effected in 30 Days (CBE-30)
supplement, which allows ongoing distribution of the product during the
review period. The CBE-30 was necessary to address some changes in raw
materials used by the manufacturer of the PAS container.
For Cerus' customers who produce INTERCEPT platelets on the Amicus
collection platform, Fresenius Kabi platelet additive solution is a key
component of the manufacturing process.
“We are cautiously optimistic that a future supply shortage for our
customers has been mitigated by the FDA decision,” noted William ‘Obi’
Greenman, Cerus’ president and CEO. “Our goal is to continue to support
our customers and help minimize potential supply disruptions pending a
final FDA approval of the change to the PAS container,” Mr. Greenman
continued.
In the U.S., INTERCEPT platelets may be produced in a mixture of PAS and
plasma (65% PAS and 35% plasma) on platelets collected on the Amicus
apheresis platform, or in 100% plasma on platelets collected on the
Trima Accel apheresis platform. An individual blood center may have both
collection platforms available, or may standardize their production on
one platform.
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.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus
Corporation. Amicus is a trademark of Fresenius Kabi. Trima Accel is a
trademark of Terumo BCT, Incorporated.
Forward-Looking Statements
Except for the historical statements contained herein, this press
release contains forward-looking statements concerning Cerus’ products,
prospects and expected results, including statements concerning Cerus’
2017 annual product revenue guidance and its expectations for U.S.
revenue contribution in 2017 and the timing thereof; and Cerus’
expectations regarding Fresenius Kabi’s ability to supply PAS. 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, the INTERCEPT Blood System, including the risks
that Cerus may not meet its adjusted revenue guidance for 2017 and/or
realize meaningful revenue contributions from U.S. customers in 2017 or
otherwise, particularly since Cerus cannot guarantee the volume or
timing of commercial purchases, if any, that its U.S. customers may make
under Cerus’ commercial agreements with these customers; risks
associated with Cerus’ lack of commercialization experience in the
United States and its ability to develop and maintain an effective and
qualified U.S.-based commercial organization, as well as the resulting
uncertainty of its ability to achieve market acceptance of and otherwise
successfully commercialize the INTERCEPT Blood System for
platelets and plasma in the United States, including as a result of
licensure requirements that must be satisfied by U.S. customers prior to
their engaging in interstate transport of blood components processed
using the INTERCEPT Blood System; risks related to Fresenius Kabi’s
efforts to assure an uninterrupted supply of PAS; risks related to how
any future supply disruption could affect INTERCEPT’s acceptance in the
marketplace; risks related to how any future supply disruption might
affect current commercial contracts; risks related to Cerus’ ability to
commercialize the INTERCEPT Blood System in the United States without
infringing on the intellectual property rights of others; risks related
to Cerus’ ability to demonstrate to the transfusion medicine community
and other health care constituencies that pathogen reduction and the
INTERCEPT Blood System is safe, effective and economical; the uncertain
and time-consuming development and regulatory process, including the
risks (a) that Cerus may be unable to comply with the FDA’s
post-approval requirements for the INTERCEPT platelet and plasma
systems, including by successfully completing required post-approval
studies, which could result in a loss of U.S. marketing approval for the
INTERCEPT platelet and/or plasma systems, (b) related to Cerus’ ability
to expand the label claims and product configurations for the INTERCEPT
platelet and plasma systems in the United States, which will require
additional regulatory approvals and (c) that Cerus may be unable to file
for CE Mark approval of the red blood cell system in Europe in the
anticipated timeframe or at all, and even if filed, Cerus may be unable
to obtain CE Mark approval, or any other regulatory approvals, of the
red blood cell system in a timely manner or at all; risks related to
adverse market and economic conditions, including continued or more
severe adverse fluctuations in foreign exchange rates and/or weakening
economic conditions in the markets where Cerus sells its products;
Cerus’ reliance on third parties to market, sell, distribute and
maintain its products; Cerus’ ability to maintain an effective
manufacturing supply chain, including the ability of its manufacturers
to comply with extensive FDA and foreign regulatory agency requirements;
the impact of legislative or regulatory healthcare reforms that may make
it more difficult and costly for Cerus to produce, market and distribute
its products; risks related to future opportunities and plans, including
the uncertainty of future revenues and other financial performance and
results, as well as other risks detailed in Cerus’ filings with
the Securities and Exchange Commission, including Cerus’ Annual 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