Swiss regulatory authorities cleared BTG’s DigiFab as an antidote for patients with life-threatening digitalis overdose. It is a polyclonal ovine antibody fragment-based therapy.
The approval is the first for DigiFab in Europe, although BTG pointed out that the drug is already available in Switzerland under a conditional marketing authorization as well as in other European countries under named-patient programs. DigiFab is also under regulatory review in Canada and the U.K.
Additional European marketing authorizations will be sought via the mutual recognition procedure. BTG has licensing agreements with Beacon Pharmaceuticals for marketing DigiFab in Europe. Beacon has sublicensed the drug’s distribution in Switzerland to Proreo Pharma.
BTG acquired DigiFab as part of its £218 million share-based buyout of Protherics in December 2009. The therapy was licensed in the U.S. in 2001 and has to date been marketed in the country by Nycomed, which also markets BTG’s CroFab™ as an antivenom for American Crotalid snake bites.
BTG contractually regains U.S. marketing rights to both CroFab and DigiFab later this year. It confirmed that it is busy ramping up its own commercial operations in the U.S. to enable direct marketing from October.