Protherics of the UK says that it has put forward a New Drug Submission to the Health Products and Food Branch of Health Canada for DigiFab, its digoxin toxicity drug.
The company noted that DigiFab (digoxin immune fab) is the leading treatment of its type in the USA, where it is approved for the treatment of life-threatening or potentially life-threatening digoxin toxicity or overdose. It added that subject to regulatory review, Protherics expects 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.
Andrew Heath, chief executive at Protherics, claimed that "DigiFab is now the established market leader in the digoxin antidote market, worth an estimated $30 million per annum, and we are consolidating this position by making our product more widely available outside of the US,” where the sector is worth around $5-10 million a year. He went on to say that “it is important to maximise our revenue-generating opportunities from our niche-marketed products, in parallel with delivering value from our recently-expanded development pipeline."
Dr Heath was referring to Protherics’ just-completed acquisition of the USA's MacroMed for $25 million, which gives it access to the latter's OncoGel, a formulation of paclitaxel for oesophageal and brain cancers, an agreement to in-license intellectual property from Glenveigh Pharmaceuticals for the use of ovine polyclonal antibody fragments for the treatment of pre-eclampsia and eclampsia and a licensing and development deal with Advancell of Spain for acadesine, a treatment for B-cell chronic lymphocytic leukaemia.