DigiFab™ for digoxin intoxification
DigiFab™ fact sheet
Digoxin Immune Fab fact sheet
Pre-eclampsia fact sheet
Efficacy Study of Digibind® for Treatment of Severe Pre-eclampsia
DigiFab™ [Digoxin Immune Fab (Ovine)] is a treatment for life-threatening digoxin toxicity or overdose. Digoxin is a widely prescribed drug for the treatment of cardiac conditions, which has a narrow therapeutic range meaning that its effective dose is close to levels where the drug becomes toxic. As a result, digoxin can cause life threatening toxicity if patients inadvertently overdose or there is a gradual build up in the body during normal treatment, or when accidentally ingested by small children.
It is estimated that approximately 7,500 cases of digoxin poisoning occur every year in Europe and the US, providing a market for digoxin antidotes estimated at between US$30-35 million per annum (company estimates). It is estimated that 16 million digoxin prescriptions were written in the US in 2006 (IMS data). Digoxin has a narrow therapeutic range, and toxicity is estimated to occur in 26% to 29% of all patients. Moreover, reported digoxin toxicities in the US were 10.5% higher in 2005 than in 1995 (AAPCC data). DigiFab™ is now the market leader in the US digoxin toxicity market, estimated to be worth approximately US$25 million per annum.
DigiFab™ was launched in the US in February 2002 by our marketing partner Fougera Inc, a division of Altana Inc. DigiFab™ is clinically interchangeable with Digibind® (GlaxoSmithKline plc), its only competitor in the US. DigiFab™ is offered at a significant price advantage to Digibind®, thereby making it an attractive option for hospital formularies. Active marketing programmes are establishing DigiFab™ as the market leader in the US.
We, together with Beacon Pharmaceuticals, our sales and marketing partner in Europe, submitted a European marketing application for DigiFab™ in September 2004. The European market for digoxin antidotes, which is believed to be worth around €5-10 million, represents a strategically important market to us in our goal to replace GlaxoSmithKline's Digibind® as the global market leader. Subject to regulatory review, we expect to receive marketing approval in the UK in the first half of 2007, in other European countries in the following six to twelve months and in Canada in 2008. In addition, Protherics recently announced an agreement with Roche to replace its digoxin antidote, Digitalis-Antidot®, with DigiFab™ to facilitate its withdrawal from the market.
We have also acquired the intellectual property for the use of polyclonal ovine antibody fragments, such as DigiFab™ and GSK’s Digibind® for the treatment of severe pre-eclampsia and eclampsia (a life-threatening complication of pregnancy).
For information about the study please click here.
DigiFab™ is also used in Sri Lanka for the treatment of Oleander poisoning, a plant commonly found in South-East Asia which contains digitalis-like substances, after accidental or deliberate ingestion.
Adverse reactions that could occur with the use of DigiFab™ include exacerbation of low cardiac output states and congestive heart failure due to the withdrawal of inotropic effect of digitalis, hypokalemia due to reactivation of the sodium-potassium ATPase, rapid ventricular response in patients with atrial fibrillation due to withdrawal of the effects of digitalis on the atrioventricular node and rare allergic reactions.
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