Clinigen Erwinaze License Application Rejected by FDA in Current Form
December 01 2021 - 4:49AM
Dow Jones News
By Joe Hoppe
Clinigen Group PLC said Wednesday that the U.S. Food and Drug
Administration has issued a complete response letter to its partner
Porton Biopharma Ltd., rejecting its leukemia treatment license
application in its current form.
The pharmaceutical services and products company said Porton is
in the process of reviewing the letter and will provide it updates
as soon as discussions with the FDA have been completed.
The company signed a global licensing and distribution agreement
with Porton in April 2020 to commercialize and distribute Erwinaze,
an acute lymphoblastic leukemia treatment designed for patients who
have developed hypersensitivity to E. coli-derived treatments.
Clinigen supplies Erwinaze to more than 30 licensed and unlicensed
markets outside the U.S.
Given that the company has recently negotiated more favorable
terms with Porton, cost-savings linked to the delayed rollout of
Erwinaze in the U.S. and its strong pipeline, Clinigen maintained
its fiscal 2022 guidance for earnings growth of 5% to 10%, and
continues to expect strong growth thereafter.
At 0903 GMT, shares were down 47.0 pence, or 7.9%, at 550.5
pence.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
December 01, 2021 04:34 ET (09:34 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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