(Alliance News) - Clinigen Group PLC announced on Wednesday that the biologics licence application for its leukaemia treatment, Erwinase, was rejected by the US Food and Drug Administration.
Erwinase is a component of a chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukaemia who have developed hypersensitivity to e-coli-derived asparaginase, an enzyme used in medication and food manufacturing.
Despite the delayed roll out in the US, Clinigen maintains its 2022 guidance for earnings before interest, tax, depreciation and amortisation will grow between 5% to 10% from GBP116 million the previous year.
Clinigen said it is in discussions with its partner Porton Biopharma Ltd over the rejected application.
"Although this is disappointing news for patients in the US, we look forward to supporting our partner PBL to ensure that patients in need outside the US are able to access Erwinase. To that end, we continue to supply Erwinase in ex-US markets," Chief Operating Officer Sam Herbert said.
Clinigen added it expects "strong, sustained growth" in the coming years, in line with current market forecasts.
Shares were up 4.2% at 625.00 pence on Wednesday afternoon in London.
By Heather Rydings; heatherrydings@alliancenews.com
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