Novartis' MS hopes expand after positive trial
- Novartis reported positive results of a Phase 3 trial in secondary progressive multiple sclerosis (SPMS) at 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in London this weekend.
- BAF312, selective sphingosine-1-phosphate (S1P) receptor modulator, reduced the risk of three-month confirmed disability progression by 21% compared with placebo (p=0.013).
- As well as reducing disability progression across a variety of predefined subgroups, the drug also significantly reduced annualized relapse rate, change in brain volume, and change in volume of brain lesions. The timed 25-foot walk test did not show a significant reduction, though.
Multiple sclerosis (MS) affects around 2.3 million people worldwide. SPMS is a more advanced form of the disease that currently has few treatment options. Therefore, the positive topline results of its Phase 3 EXPAND study of BAF312 (siponimod) have given patient's something to celebrate.
Analysts at Jefferies suggest that the positive results from this large study could mean an earlier than expected approval, and that it could be a leading treatment for around a third of patients with MS. This could make it a high-margin blockbuster.
If BAF312 does gain approval, it could make up for the impending patent loss of Gilenya (fingolimod), approved for relapsing remitting MS (RRMS). Gilenya is Novartis' second-highest selling drug. It had earnings of $2.78 billion worldwide in 2015.
There are a number of big pharma and biotech aiming for the MS market, but there have been plenty of setbacks in the space. Biogen's natalizumab was hit hard in Phase 3; its ASCEND study did not meet its primary and secondary endpoints in SPMS, although it did improve upper limb function. And another of Biogen's drugs is facing challenges. Opicinumab was hoped to not only slow but reverse nerve damage in RRMS. While it didn't meet the primary endpoint in Phase 3, Biogen remains confident. However, Biogen, with AbbVie, has succeeded in getting Zinbryta (daclizumab) to the market for RRMS, but has had to accept a boxed warning and restricted distribution because of safety risks..
Teva's laquinimod, which was the hope to replace Copaxone as it goes off patent and faces generic competition, has had problems in its Phase 3 ALLEGRO study, when the high dose of the drug was withdrawn in the light of non-fatal cardiovascular events. The company announced Monday that the U.S. Food and Drug Administration has rescinded its Special Protocol Assessment for the drug.
Roche has had more success in Phase 3 trials. Roche's drug Ocrevus (ocrelizumab) was more successful than placebo in primary progressive multiple sclerosis than Merck KGaA's Rebif in relapsing multiple sclerosis, according to post-hoc analyses. Ocrevus has gained priority review status from the FDA, with a decision scheduled for late December 2016. Approval would make it the first multiple sclerosis treatment approved for both relapsing-remitting and primary progressive forms.
- Novartis Statement
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