Biogen Starts Patient Enrollment - Analyst Blog

Biogen Idec (BIIB) and Abbott (ABT) recently announced that they have started enrolling patients for their phase III study with daclizumab. The study– DECIDE, will evaluate the efficacy and safety of daclizumab in patients suffering from relapsing-remitting multiple sclerosis (RRMS). The candidate will be compared with Biogen’s Avonex.

 

With the enrolment of the first patient, Biogen will have to make a $30 million milestone payment to Abbott. Abbott gained access to daclizumab with its recent acquisition of Facet Biotech.

 

The worldwide, randomized, double-blind, active-comparator phase III study will be conducted with about 1,500 RRMS patients across 28 countries. A once-monthly subcutaneous formulation of daclizumab will be evaluated as a monotherapy.

 

Daclizumab is currently undergoing another study as well. The candidate is in a phase IIb registration-enabling study (SELECT), which is evaluating its efficacy and safety (150 mg or 300 mg) as a monotherapy.

 

The successful development of daclizumab should help strengthen Biogen’s product portfolio. Biogen is the market leader in therapies used to treatment multiple sclerosis (MS) and the company is working on consolidating its position in the multiple sclerosis market. Multiple sclerosis is one of the most common neurological disorders and is estimated to affect more than 2.5 million people worldwide.

 

Biogen’s largest product, Avonex, posted sales of $2,322.9 million, up 5.5%, in 2009. Meanwhile, Tysabri, Biogen’s second multiple sclerosis product, continued to see an increase in patients despite carrying a black box warning for the risk of progressive multifocal leukoencephalopathy (PML) and other cautionary language. Tysabri crossed $1 billion in sales in 2009.

 

Besides daclizumab, other multiple sclerosis candidates in Biogen’s pipeline include Ampyra, which was launched recently in the US by Acorda (ACOR) and BG-12, which is currently in phase III trials. Biogen is responsible for the non-US development and commercialization of Ampyra and has filed for both Canadian and EU approval of the product.

 

We currently have a Neutral recommendation on Biogen. We are encouraged to see that the company is working on expanding its multiple sclerosis and oncology pipeline. Besides this, Biogen has a number of other mid-to-late stage drugs in other therapeutic areas that could contribute significantly to growth in the next several years.

 

Although Biogen’s core business should remain stable in the coming quarters, we believe investor focus will remain on the occurrence of additional cases of PML associated with the use of Tysabri.