Biogen Idec Announces Strides In Clinical Studies For MS Treatments
By Lori Clapper
Biogen Idec announced clinical study results for three of its Multiple Sclerosis (MS) treatments at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis in Boston last week.
Biogen presented clinical study results from the following treatments:
Zinbryta: Biogen and AbbVie presented their final results from the Phase 3 DECIDE clinical trial of Zinbryta (daclizumab high-yield process), dosed subcutaneously once a month. The data showed a statistically significant reduction of disease activity in people with relapsing-remitting multiple sclerosis (RRMS) compared to Avonex (interferon beta-1a).
The primary endpoint for the drug was to see an annualized relapse rate (ARR) of 45 percent compared to patients treated with Avonex.
Tecfidera: In addition, Biogen presented five-year results from its ENDORSE Phase 3 extension study of Tecfidera (dimethyl fumarate), which resulted in a strong and sustained efficacy in a broad range of people living with RRMS.
The safety profile remained consistent among all patients who took Tecfidera, including those who were treated for up to 7.5 years, according to a company press release. And in newly diagnosed patients, the DEFINE and CONFIRM studies of Tecfidera had a positive, long-term effect on MS relapse rates, disability progression, and MRI measures in these patients.
“Tecfidera continues to provide patients with effective oral treatment for MS that is supported by a growing body of data reinforcing its benefits and favorable safety profile,” Alfred Sandrock, group SVP and CMO at Biogen Idec, said. “These new ENDORSE results provide further insight into the positive impact of using Tecfidera early in the course of MS and for long-term treatment of this chronic disease.”
Plegridy: The Phase 3 ADVANCE clinical trial of Plegridy demonstrated that the drug continued to have a positive effect on people with relapsing forms of multiple sclerosis (RMS) more than a year past the study.
“A significantly higher proportion of patients taking Plegridy during both years of the study experienced no evidence of disease activity (NEDA) – defined as the absence of clinical and MRI disease activity over two years of treatment – compared to those who switched to Plegridy from placebo,” the company said.
The successful progression of MS clinical trials is good news for MS sufferers. Although there are a number of new treatments currently in the pipeline, most are in early phases of research, the Boston Globe reported.
Of course, this data also suggests good things ahead for the company in term of prominence in the market. “Worldwide sales of MS drugs totaled more than $16 billion last year and are projected to top $20 billion within the next two to three years, with MS pills accounting for about half of the sales,” said Eric Schmidt, biotech analyst at New-York based investment bank Cowen & Co. “The MS market is in need of a variety of therapeutic approaches.”
He added that Biogen’s current “blockbuster” MS drugs Avonex, Tysabri, and Tecfidera, generate more than $1 billion in revenue annually.