Biogen, Roche & Novartis Present Data on MS Drugs in Spain
Quite a few pharma/biotech companies presented encouraging data on their multiple sclerosis (MS) candidates at the 31st Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Barcelona, Spain held this week.
The MS market is getting more crowded with existing players coming out with new drugs and new entrants trying to enter the market.
Market leader Biogen Inc. BIIB, with key drugs like Tecfidera, Avonex and Tysabri, is collaborating with AbbVie ABBV for another MS candidate, Zinbryta. Results from the phase III study, DECIDE, on Zinbryta was published in the New England Journal of Medicine. Data was also presented at the ECTRIMS by the lead investigators of the study.
The study shows that once-monthly Zinbryta improved results on key measures of MS disease activity in patients with relapsing-remitting MS compared to interferon beta-1a 30 mcg intramuscular injection. A post-hoc analysis of data from the study showed Zinbryta was effective in increasing the percentage of patients who showed improved cognitive processing speed and decreased 24-week confirmed disability progression across a broad range of subgroups at two years compared to interferon beta-1a IM. The candidate is currently under review in the U.S and the EU.
Meanwhile, Swiss oncology major, Roche RHHBY announced positive data from phase III studies, OPERA I and OPERA II, on MS candidate, ocrelizumab . The data will be presented at ECTRIMS.
The candidate is being evaluated for the treatment of patients suffering from MS and primary progressive multiple sclerosis (PPMS). Data from the studies showed that ocrelizumab was superior to interferon beta-1a (Rebif) in lowering the three major markers of disease activity over the two-year controlled treatment period in patients suffering from relapsing MS.
Additionally, a separate study, ORATORIO, showed that ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks (the primary endpoint) and 24 weeks (a secondary endpoint) compared to placebo in patients suffering from PPMS. Consequently, the study met its primary endpoint. In addition, the study met other secondary endpoints of reducing the time required to walk 25 feet, the volume of chronic inflammatory brain lesions and brain volume loss.
The results bode well for Roche, which is trying to expand its portfolio beyond oncology to immunology, neuroscience and ophthalmology. Roche plans to submit data from all three studies to the FDA by early 2016.
Novartis NVS also presented new analysis at ECTRIMS from two phase III trials (FREEDOMS and FREEDOMS II) on MS drug Gilenya, which reinforced its long-term effectiveness. The company conducted a follow-up analysis of pooled data from the FREEDOMS and FREEDOMS II core and extension trials to assess no evidence of disease activity each year for seven years in patients with relapsing MS. Apart from Gilenya, Novartis’ Extavia is approved in the EU to treat people with RRMS and secondary progressive MS.
As per National Institutes of Health – National Institute of Neurological Disorders and Stroke and Multiple Sclerosis International Federation, MS is a chronic disease that affects an estimated 2.3 million people around the world with no cure. Hence, the MS market still has a lot of scope for new treatments.
While Biogen and Roche carry a Zacks Rank #3 (Hold), Novartis is a Zacks Rank #4 (Sell) stock. AbbVie carries a Zacks Rank #2 (Buy).
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