Antegren goes for European approval

ELAN submitted its flagship Antegren drug for approval by European regulators as a treatment for Crohn’s disease yesterday, saying tests showed it worked over a 12-month period.

Antegren, which is being developed with US partner Biogen Idec, has led a dramatic recovery in Elan’s fortunes, after its stock plunged 90% in 2002 on concerns about liquidity and an accounting probe by US market regulators.

Analysts think the medicine, which is being developed primarily as a treatment for multiple sclerosis, but also for Crohn’s and rheumatoid arthritis, could generate annual sales of more than $1 billion.

Elan said new data showed 54% of Crohn’s patients recorded a continued response to Antegren after 12 months of a final Phase III clinical trial.

This compared with a response rate of 20% from patients on a placebo and a 61% response rate recorded by patients on Antegren after six months.

Some 39% of patients treated by Antegren remained in remission after 12 months, versus 15% of those on a placebo and 44% after six months.

In addition, 49% of Antegren patients who had previously received steroid therapy were able to withdraw from steroids at the end of the 12-month period, compared with 20% of placebo-treated patients.

“This filing and the presentation of 12-month data from the ENACT-2 study represent important milestones in our development of natalizumab (Antegren) as a treatment for Crohn’s disease,” said Lars Ekman, executive vice president and president for research and development.

Crohn’s disease is a chronic and progressive inflammatory disease of the gastrointestinal tract, which cases diarrhoea, abdominal cramps, often fever and at times rectal bleeding.

Elan and Biogen submitted Antegren for US approval as a treatment for multiple sclerosis in May and announced in June they had received a priority review from the US Food and Drug Administration to speed up the assessment process.