American regulator blocks distribution of cancer treatment
American regulators have blocked pharmaceutical group Clinigen from distributing an enzyme used to treat leukaemia.
Clinigen agreed an exclusive worldwide licensing agreement for Erwinase that began in January and its manufacturer Porton Biopharma (PBL) has since pursued a strategy of obtaining marketing authorisations in its name in numerous territories.
However PBL has now received a Complete Response Letter from the US Food and Drug Administration refusing the licence application.
Erwinase is used to treat patients with acute lymphoblastic leukaemia, a type of cancer that particularly affects children. It was first registered in the UK in 1985 and approval was originally obtained from the US FDA in 2011.
Sam Herbert, group chief operating officer at Clinigen, said: “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.”
Clinigen currently supplies Erwinase into more than 30 licensed and unlicensed markets outside the US.
Despite the setback, Burton-based Clinigen expects profits to be unaffected because of a recent negotiation of more favourable commercial terms with PBL and the continued strength of its pipeline.
Clinigen has maintained its guidance for the current financial year of EBITDA growth of 5-10%, and said it “continues to expect strong, sustained growth in the years thereafter” in line with current market forecasts.