Pharmaceutical group Elan and its US partner Biogen have begun Phase III trials on their Antegren treatment for multiple sclerosis and Crohn's Disease. Phase III is the final stage of testing on patients before an application can be made for drug approval by the Food and Drugs Administration.
The confirmation that Antegren testing had progressed to Phase III did not come as a surprise to the market and had little impact on Elan's share price. The Phase III testing had been anticipated but, if these final trials are successful and approval for the treatment is forthcoming, it opens up a potential $1 billion (€1.11 billion) market for Elan and Biogen.
The Phase III trials on MS patients have already begun and trials on Crohn's patients are expected to begin before the end of the year. According to Elan, Antegren was generally well tolerated by Phase II patients and the common adverse effects were headache and urinary tract infections in the case of MS sufferers, and headache and abdominal pain in the case of Crohn's Disease sufferers. The reaction from analysts was positive and ABN Amro Stockbrokers said Antegren had the potential to be a key driver of Elan's growth in the long term, with $150 million sales in 2005. NCB said: "We believe that Antegren may be a new and effective treatment for MS and Crohn's Disease patients due to its greater efficacy and potentially favourable side-effect profile."
NCB suggested the first half of 2005 as a likely launch date for the drug if the current trials are successful.