A pending Platelet Additive Solution shortage is expected to impact
some U.S. blood centers producing INTERCEPT platelets
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that it received
notification last week of a pending U.S. supply shortage of a platelet
additive solution (PAS) manufactured and sold by Fresenius Kabi.
The pending shortage is due to an unanticipated delay in FDA approval of
a plastic component used in the manufacture of the PAS container
following discontinuation of the original component by Fresenius Kabi's
supplier. The shortage is expected to temporarily impact certain U.S.
blood centers that utilize PAS to produce INTERCEPT platelets.
Fresenius Kabi has stated that it is working with its suppliers and the
FDA to resolve this delay and minimize any long-term disruption in
supply.
Cerus is committed to supporting all blood centers, hospitals and
patients who rely upon the INTERCEPT system to safeguard their platelet
supply. "We believe that access to pathogen reduced platelets is
critical for all patients, and are doing everything we can to support
impacted blood centers and also their hospital customers who are using
or wish to use INTERCEPT platelets," said William 'Obi' Greenman, Cerus'
president and CEO.
“For our customers who produce INTERCEPT platelets on the Amicus
collection platform, availability of this Fresenius Kabi PAS product is
essential to their continued production of pathogen reduced platelets.
We understand that Fresenius Kabi anticipates the supply shortage will
be temporary, and we believe the shortage could adversely affect
INTERCEPT platelet production by impacted blood centers through year
end," Mr. Greenman continued.
As a result of the expected impact of the PAS supply disruption on
INTERCEPT platelet production, the Company is updating its 2017 product
revenue guidance to a range of $38 million to $46 million compared to
the prior range of $43 million to $48 million.
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 remedy the supply
shortage of 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 remedy the supply shortage of PAS in a meaningful and timely
manner; risks related to how the supply shortage could affect
INTERCEPT’s acceptance in the marketplace; risks related to how the
supply shortage may effect 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