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.
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.
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.