February 04, 2010
BTG Receives First European Regulatory Approval for DigiFab™
London, UK, 04 February 2010
- DigiFab™ Approved in Switzerland -
BTG plc (LSE: BGC), the specialty pharmaceuticals company, today announces that Swissmedic, the Swiss Agency for Therapeutic Products, has approved the antidote DigiFab™ for the treatment of patients with life-threatening digitalis intoxication. DigiFab™ is already available in Switzerland under a conditional marketing authorisation and in other European Countries under named patient programmes.
BTG plc has a licensing agreement with Beacon Pharmaceuticals Ltd for the marketing of DigiFab™ in Europe and Beacon has sub-licensed DigiFab™ distribution in Switzerland to Proreo Pharma AG.
DigiFab™ has been licensed by the US Food and Drug Administration since 2001 and BTG is establishing commercial operations to market DigiFab™ in the US from 1st October 2010. DigiFab™ is currently under review by the MHRA, the UK regulator and by Health Canada, the Canadian regulatory authority. BTG plans to seek additional European approvals in due course via the mutual recognition procedure.
Digoxin, also known as digitalis, is a drug used to treat congestive heart failure and to slow heart rate in some cardiac disturbances. It has a narrow therapeutic window, meaning it is easy to move from therapeutic levels to toxic levels as a result of overdose, slow elimination or interaction with other drugs. DigiFab™ works by binding and neutralising digoxin, facilitating its redistribution away from target tissues and elimination from the body.
Louise Makin, BTG’s CEO, commented: “We are delighted to announce BTG’s first European approval for DigiFab™. This comes as we continue to progress preparations to market both CroFab™ and DigiFab™ in the US from 1st October 2010.”
For further information contact:
Ashley Tapp, Communications Manager
+44 (0)20 7575 1513; mobile: +44 (0)7790 811554
Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7575 0000
+44 (0)20 7831 3113