Elan expects Tysabri drug to achieve blockbuster status

Irish biotech group Elan expects its multiple sclerosis treatment, Tysabri, to achieve blockbuster status by the end of this year.

Company chief executive Kelly Martin said sales of the drug were running at an annualised rate of $500 million (€343 million) at the end of last year and he expected that figure to hit $1 billion by the end of 2008.

For 2007 as a whole, Tysabri recorded sales of $343 million. The number of doctors prescribing the treatment, which is strictly supervised, doubled over the course of 2007 to 2,500.

The success of Tysabri, which has also been approved recently in the United States as a treatment for Crohn's disease, was cited yesterday as the driving force behind the 36 per cent increase in revenues at the company.

Elan recorded an increase in net losses for the year as a whole - $405 million last year against $267.3 million in 2006. Chief financial officer Shane Cooke said the 2006 figure includes exceptional gains from the sale of European rights to its Prialt drug and a court settlement award. The 2007 loss includes $103.4 million in charges related to the arrival of generic competition for its Maxipime drug earlier than expected, restructuring of its US operations and the early repayment of debt.

On the basis of earnings before interest, tax, depreciation and amortisation (Ebitda), Elan recorded a loss of $30.4 million for 2007, down from $91.1 million in 2006 and under its projected figure of $50 million. Research and development costs jumped 21 per cent to $260.4 million for 2007 as a whole, and by 40 per cent in the fourth quarter as the company ramps up its Alzheimer's programmes.

The company is again projecting a full year Ebitda loss of around €50 million this year as it invests heavily in R&D on a string of Alzheimer's therapies.

However, Mr Martin said the company expected to be "Ebitda positive" in the second half of 2008.

Elan hopes to disclose headline data on the Phase II trials of its most advanced Alzheimer's programme by mid-year and hopes to present full data at the 12th International Conference on Alzheimer's Disease and Related Disorders at the end of July.

Tysabri moved into profit in the fourth quarter of 2007 and 21,000 multiple sclerosis sufferers are now using the drug, up from around 7,500 this time last year. There has been a significant increase in the number of patients outside the US using the therapy in recent months.

Elan expects to start treating US Crohn's patients within the next month, although the drug will not be available in Europe, where regulators have blocked it. Mr Martin said it could be three years before it returned to European regulators with the benefit of data from the US rollout.