Shares of Cerus Corp. (NASDAQ: CERS) are up 11.2% after the biomedical products company said an expected shortage of Fresenius Kabi platelet additive solution (PAS) could be less disruptive to blood center production of INTERCEPT platelets thanks to a key decision by the FDA. The agency is reviewing a recent submission by Fresenius Kabi as a Changes Being Effected in 30 Days (CBE-30) supplement to address some changes in raw materials used by the manufacturer of the PAS container. CBE-30 allows ongoing distribution of the product during the review period, which could minimize impact. “We are cautiously optimistic that a future supply shortage for our customers has been mitigated by the FDA decision,” Cerus president and CEO William ‘Obi’ Greenman stated in the news release. “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.”
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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.
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