Biogen Plans First Study For Earlier Use Of MS Drug Tysabri

Biogen Idec Inc. (BIIB) is planning the first clinical trial that could lead to use of controversial multiple sclerosis treatment Tysabri, sold with Elan Corp. (ELN), at earlier stages of the disease.

The long-term trial, dubbed Surpass, will measure the effectiveness of Tysabri in patients with active MS that have switched from either Teva Pharmaceutical Industries Ltd.'s (TEVA) Copaxone or Rebif, sold by Pfizer Inc. (PFE) and Germany's Merck KGaA (MRK.XE, MKGAY).

Tysabri is considered a highly effective therapy for MS, and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped amid concerns about the risk of a rare brain infection that led to its 18-month market withdrawal beginning in 2005. The study comes after Tysabri brought in more than $1 billion in 2009, and it is part of Biogen's push to accelerate Tysabri's growth.

It also comes amid increased competition in MS treatments. Novartis AG (NVS, NOVN.VX) and Germany's Merck KGaA (MKGAY, MRK.XE) could launch oral treatments for the disease this year, a notable advance compared to the injections and infusions required with current drugs.

The goal of the Surpass trial is to get physicians to use Tysabri when patients aren't responding to their current therapy, rather than switching them to more mainstream therapies.

Beside Copaxone and Rebif, other common options include Biogen's Avonex and Bayer AG's (BAY.XE BAYRY) Betaseron, while Tysabri is generally reserved for patients with very aggressive disease or have no other options.

"We are trying to establish that there is no use in switching around [prior to using Tysabri]," Biogen spokeswoman Naomi Aoki. The company is signing up sites for the trial and has yet to enroll the first of an estimated 1,800 patients.

The study will follow participants for about two years and isn't likely to yield data until 2013 or 2014. If successful, the result should allow Biogen to update Tysabri's label and allow it to market the earlier use to physicians.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; [e-mail]