BTG plc (BGC.L) Receives First European Regulatory Approval for DigiFab(TM)
2/4/2010 11:54:02 AM
London, UK, 4 February 2010: 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.”
BTG is an international specialty pharmaceuticals company that is developing and commercialising products targeting critical care, cancer, neurological and other disorders. The company is also seeking to acquire new products to develop and market to hospital specialists, and is building a sustainable business financed by revenues from sales of its critical care products and from royalties and milestone payments on partnered products. For further information, visit: www.btgplc.com.
About Beacon Pharmaceuticals Ltd
For further information, visit: www.beaconpharma.co.uk