Tue Apr 16, 1:25 PM ET
CAMBRIDGE, Mass. -(Dow Jones)- Biogen Inc. (NasdaqNM: BGEN - news) (BGEN)
launched an international multi-center study to determine the long-term
safety, tolerability and efficiency of its multiple sclerosis drug Avonex,
compared with Serono S.A.'s ( SRA) Rebif.
In a press release Tuesday, Biogen said Thomas Murray, M.D. of Dalhousie University in Halifax , Canada, will head the research initiative as the principal investigator.
"This study will be the first to evaluate the effect of these two interferon therapies over a sustained and long period of time in patients with relapsing multiple sclerosis," Murray said.
To evaluate the long-term effect of therapy on the disease, the two-phase study will first evaluate patients who have been on either Avonex or Rebif therapy for a minimum of 15 to a maximum of 21 months prior to enrollment in the trial and have an Expanded Disability Status Scale score between 0.0 and 5.5.
An EDSS score is an established neurological scale that measures physical disability.
The patients will be divided into two groups: one includes patients who were treated with a 30 mcg dose of Avonex administered intramuscularly once a week and the other includes patients treated with 44 mcg of Rebif administered subcutaneously three times a week.
The second phase of the study will follow these patients and others for an additional three years to evaluate efficiency of Avonex on a number of clinical and MRI measures.
The study's clinical research team will include neurologists and other MS researchers.
As reported earlier in March, the U.S. Food and Drug Administration (news - web sites) allowed Swiss biotechnology company Serono to sell its multiple-sclerosis drug Rebif in the U.S. , one year earlier than expected.
This has effectively broken Avonex's orphan drug status, and sent shares of Biogen into a downward spiral.
Shares of Biogen recently traded at $45.28, down $1.10, or 2.4%, on Nasdaq volume of 1,576,600 shares. Average daily volume is 3.36 million shares.
Shares of Serono were recently trading up 6 cents, or 0.3%, to $21.25.
Company Web site: http://www.biogen.com
-Hongyun Liu; Dow Jones Newswires; 201-938-7477
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