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.
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 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.