Novartis, Biogen Idec release more strong data on hot-selling MS pills

Novartis ($NVS) and Biogen Idec ($BIIB) continued to roll out new data about their multiple sclerosis treatments yesterday at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting in Copenhagen, Denmark. The day after showing that two of their respective therapies provided better results with earlier treatments, the companies followed up with analyses of safety and brain volume loss for their oral drugs, both of which have already gained significant market share in treating the disease.

Thursday, Novartis announced new data showing that continued Gilenya (fingolimod) treatment led to a reduction in brain volume loss in patients with relapsing forms of MS. The company touts the blockbuster as the only oral treatment that reduces the rate of brain volume loss--one of the best indicators of disability progression over the long-term, it says. Patients with higher rates of brain volume loss were more likely to see the disease progress, while those who remained MS-free had consistently lower rates of brain volume loss. And using Gilenya for four years instead of two was more effective to that end, with four-year treatment cutting brain volume loss by a third.

Dr. Timothy Wright, Novartis' global head of development, called the data very encouraging for the drug. "They are from studies that took place over four years and show that Gilenya both reduces brain volume loss and slows the pace of disability progression for patients with MS. These are key treatment goals for patients with this chronic and debilitating illness," he said.

That news followed analyses Novartis unveiled earlier in the conference comparing Gilenya with other standard MS treatments. In a study using data gathered from a disease registry and a health claims database, Gilenya sliced the annualized relapse rate by about 50% compared with Teva's ($TEVA) Copaxone (glatiramer acetate) or interferon drugs. Patients with a history of relapse also saw fewer of them after making the switch to Novartis' therapy. The MS drug, which has rapidly grown market share since its 2010 launch, raked in $889 million in the first half of this year, and analysts expect it to reach peak sales of about $2.5 billion in 2018. 

The day after releasing positive data for its injectable drug Tysabri (natalizumab), Biogen Idec presented safety and efficacy data for its oral MS drug Tecfidera (dimethyl fumarate), which made a splash when it rolled out about 6 months ago. Data from Biogen Idec's ENDORSE study showed that Tecfidera reduced disease activity in patients taking the drug for four years, while those receiving treatment for 6.5 years saw no new or worsening safety issues. "Because MS is a chronic, life-long disease, physicians and patients need to know they are taking a treatment that will offer them sustained efficacy over the long-term with a consistent safety profile," said Doug Williams, Biogen's EVP of R&D.

Additionally, analyses from separate trials showed that Tecfidera significantly reduced relapses in treatment-naïve patients and delayed the disease's overall progression. That data should give the drug a boost as it continues to compete with earlier-to-market MS pills Gilenya and Sanofi's ($SNY) Aubagio (teriflunomide). After pulling in $192.1 million between its April launch and the end of 2013's first half, analysts project the drug will hit $3.78 billion in sales by 2018.

More study results will follow at the ECTRIMS meeting, which wraps up tomorrow.  

- get the statement from Biogen
- check out the Novartis release

Special Reports: Top 15 Drug Launch Superstars - Gilenya - Tecfidera | Top 15 highest paid biopharma R&D chiefs - Doug Williams

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