Cerus Provides Update on U.S. Platelet Additive Solution (PAS) Supply
June 07 2017 - 08:30AM
Business Wire
Manufacturer of PAS No Longer Anticipates
Future Shortage
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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version on businesswire.com: http://www.businesswire.com/news/home/20170607005457/en/
Cerus CorporationLainie Corten - Vice President, Global
Marketing & Investor RelationsTim Lee - Investor Relations
Director(925) 288-6137ir@cerus.com
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