UK-based biotechnology company BTG plc (BGC.L) said Thursday that Swissmedic, the Swiss Agency for Therapeutic Products approved its antidote Digifab to treat heart drug digoxin intoxication.
Digoxin, also known as digitalis, is 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. Digoxin toxicity causes potentially life-threatening heart rhythm disturbances. The first antidote for digoxin to be approved by the FDA is GlaskoSmithKline Plc's (GSK) Digibind or Lanoxin. (approved in 1986)
In the U.S. around 0.4% of all hospital admissions, 1.1% of outpatients on digoxin, and 10-18% of nursing home patients develop toxicity. Annual prescriptions of digoxin in the U.S. total 16 million. Internationally, nearly 2.1% of inpatients on digoxin and 0.3% of all admissions develop toxicity.
Digifab is a sterile, purified, lyophilized preparation of digoxin-immune ovine Fab immunoglobulin fragments obtained from the blood of healthy sheep immunized with a digoxin derivative. The drug works by lowering the amount of digoxin in the blood thereby reducing its cardio-toxic effects.
BTG has a licensing agreement with Beacon Pharmaceuticals Ltd. for the marketing of Digifab in Europe, which in turn has sub-licensed the distribution rights in Switzerland to Proreo Pharma AG.
Digifab was approved by the FDA in 2001. BTG added Digifab and antivenom CroFab to its portfolio when it acquired Protherics PLC in December 2008.
Digifab is marketed by Nycomed in the U.S and by Beacon Pharmaceuticals in the EU, excluding Nordic countries, and by BTG in the rest of the world. BTG's current lisencing agreement with Nycomed US, the US specialty pharmaceutical business of Switzerland's Nycomed International, expires in October 2010, upon which it intends to establish commercial operations on its own.
BTG informed that Digifab is already available in Switzerland under a conditional marketing authorization and in other European Countries under named patient programmes. BTG's licensee Beacon Pharmaceuticals Ltd. has sub-licensed the distribution rights in Switzerland to Proreo Pharma AG.
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.
BTG noted that it has acquired the intellectual property for the use of Digifab and GSK's Digibind, polyclonal ovine antibody fragments, currently assessed for potential treatment of severe pre-eclampsia and eclampsia, a life-threatening complication occurring in 10% of pregnancies worldwide per year. Currently there are no approved therapies available to treat pre-eclampsia and few products in development.
BTG's pipeline comprises development programmes in oncology, neurological and other disorders including treatment of varicose veins, oesophageal cancer, hypertension, multiple sclerosis and migraine.
The company also has drug development programs in partnerships with Genzyme Corp. (GENZ), Johnson & Johnson's (JNJ) Cougar Biotechnology, AstraZeneca plc (AZN) and Onyx Pharma (ONXX) to name a few.
"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," noted Louise Makin, BTG's CEO.
BGC.L is currently trading at 181.90 pence, on the LSE.
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