The pending shortage is due to “an unanticipated delay” in FDA approval of a plastic component used to manufacture the PAS container. The original component was discontinued by Fresenius Kabi’s supplier, the company reported.
In the U.S., Intercept platelets can be made in a mixture of PAS and plasma on platelets collected using the Amicus apheresis platform.
Fresenius Kabi said it is working with its suppliers and the federal regulatory watchdog to resolve the delay.
In response to the expected impact of the supply disruption, Cerus lowered its product revenue guidance to a range of $38 million to $46 million, down from $43 million to $48 million.
“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,” president & CEO William Greenman said in prepared remarks. “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.”
CERS shares tumbled more than -20% today, trading at $2.35 in mid-morning activity.