Zeev's Turnips Patch-No Politics (ZEEV)

[James T Kirk]

UPDATE - Elan, Biogen drug works in follow-on Crohn's trial
Tuesday May 18, 4:12 pm ET

(Adds timing of filing with EU)

NEW YORK, May 18 (Reuters) - An experimental drug to treat a severe bowel disorder cut symptoms for six months among patients who had responded to the treatment in an earlier trial, co-developers Elan Corp Plc and Biogen Idec Inc. said on Tuesday.

The results, presented at a medical meeting in New Orleans, prompted the companies to announce they would file with the European Medicines Agency, for approval of the drug in bowel disorder Crohn's disease in the fourth quarter of 2004.

The late-stage trial of the drug Antegren followed a three-month trial disclosed last July in which Antegren failed to prove significantly effective in treating Crohn's disease, a bowel disease whose symptoms include diarrhea, abdominal pain and fever.

The six-month trial reported on Tuesday included those patients from the first trial who had responded to the drug initially to see if they would continue to benefit. Both trials compared the effectiveness of Antegren against a placebo.

In the trial for Crohn's disease, 61 percent of patients taking Antegren were still responding to the therapy after six months, compared with 29 percent of patients on a placebo. The results were statistically significant.

Elan (Irish:ELN.I - News; NYSE:ELN - News) and Biogen Idec (NasdaqNM:BIIB - News) are also testing Antegren for multiple sclerosis, a bigger market. The medicine is considered the jewel in the experimental pipelines of both companies, which both need new drugs to drive profit growth.

The companies reiterated an earlier intention to submit a U.S. marketing application before the end of the current quarter for Antegren as a treatment for multiple sclerosis.

Elan is recovering from a financial crisis in 2002, when its stock plunged and investors worried if it would be able to pay its big debt load after a U.S. probe into accounting practices. But the Irish drugmaker has sold assets, narrowed its focus, and said last week its first-quarter loss narrowed.

Biogen Idec was formed from the merger late last year of Biogen Inc. and Idec Pharmaceuticals Inc. Its biggest-selling drug is multiple sclerosis treatment Avonex. Antegren is intended to be a follow-on, and perhaps improved, method of treating multiple sclerosis.

Antegren is designed to stop the migration of immune cells into chronically inflamed tissue where they cause or exacerbate inflammation, a product of both Crohn's and multiple sclerosis. Crohn's disease affects about 1 million people worldwide.

In the 339-patient clinical trial reported on Tuesday, the companies also said 44 percent of patients maintained remission of Crohn's after six months, compared with 26 percent on a placebo. The difference was considered statistically significant. (--additional reporting by Kim Dixon in Chicago)

http://biz.yahoo.com/rc/040518/health_elan_biogen_2.html