Swiss pharma giant Novartis NVS announced positive results on pipeline candidate ofatumumab (OMB157) from two late-stage studies for the treatment of relapsing forms of multiple sclerosis (RMS).
The phase III ASCLEPIOS I and II studies investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once-daily oral dose of Sanofi’s SNY Aubagio 14mg in adults with RMS.
Data from the head-to-head studies showed that ofatumumab was superior to Aubagio in MS patients with a favorable safety profile. Both studies met the primary endpoints. Ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as annualized relapse rate (ARR). Key secondary endpoints of delaying time to confirmed disability progression were also met. Novartis plans to initiate submissions to health authorities by the end of 2019.
Ofatumumab works by binding to the CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion. If approved, ofatumumab has the potential to become a treatment option for a broad RMS population, including early MS. It will also be the first B-cell therapy that can be self-administered at home.
Novartis initiated a phase III program on ofatumumab in RMS in August 2016 after obtaining rights from Genmab in all indications, including MS, in December 2015. We note that ofatumumab is marketed by the company for oncology indications as an intravenous infusion under the brand name, Arzerra.
Novartis’ shares have gained 3.8% in the year so far against the industry’s decline of 1.7%.
A potential approval will strengthen the company’s MS portfolio, which includes approved drugs like Gilenya and Extavia (interferon beta-1b for subcutaneous injection). Earlier this year, Novartis obtained FDA approval for Mayzent (siponimod), a next-generation, selective sphingosine 1-phosphate receptor modulator, for the treatment of adults with RMS. The FDA approved the drug for the treatment of secondary progressive multiple sclerosis (SPMS) with active disease, relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS).
Novartis’ generic division, Sandoz, markets Glatopa, a generic version of Teva Pharmaceuticals’ TEVA Copaxone (both 20 and 40 mg).
However, competition is stiff in the market. We note that Biogen, Inc. BIIB holds a strong position in the MS market, with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy.
Novartis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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