Cerus lowers FY17 product revenue guidance as a result of the expected impact of the platelet additive solution (:PAS) supply disruption on INTERCEPT platelet production :
Co 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.
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.
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