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J&J Files NDA for Multiple Sclerosis Drug Ponesimod in U.S.

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Johnson & Johnson (JNJ - Free Report) submitted a new drug application (NDA) to the FDA seeking approval of ponesimod for treating adults with relapsing forms of multiple sclerosis (RMS). Please note that a marketing application seeking approval of ponesimod in Europe was filed earlier this month.

J&J’s shares have outperformed the large-cap pharma industry in the past year. The stock has declined 7.4% in the said timeframe compared with the industry’s 12.8% decrease.

 

The regulatory filings were based on data from the head-to-head OPTIMUM phase III study. In the study, ponesimod, a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, demonstrated superior efficacy to Sanofi’s (SNY - Free Report) MS drug, Aubagio on the primary endpoint of reduced annualized relapse rate (ARR), as well as most secondary endpoints. Data from the OPTIMUM study showed that ponesimod reduced ARR in MS patients by a statistically significant 30.5% compared to Aubagio, up to 108 weeks following the treatment.

Please note that ponesimod was added to J&J’s pipeline with the June 2017 $30-billion acquisition of Swiss biotech, Actelion.

Multiple sclerosis is a crowded market, with many companies already having drugs in their portfolio approved for this indication. Biogen (BIIB - Free Report) holds a strong position with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. Israel-based Teva Pharmceuticals (TEVA - Free Report) has long been in the market with its widely used drug, Copaxone, which has now lost patent protection and generics are rapidly eroding its revenues.

Novartis’ portfolio comprises approved drugs like Gilenya and Extavia for the treatment of relapsed MS. Novartis’s Mayzent (siponimod), a next generation, selective sphingosine 1-phosphate receptor modulator, was approved to treat RMS in March 2019. Meanwhile, Novartis’ regulatory applications seeking approval of subcutaneous ofatumumab, a novel B-cell to treat RMS, were accepted for review by the FDA and European Medicines Agency (EMA) in late February. Ofatumumab is marketed by Novartis for oncology indications as an intravenous infusion under the brand name, Arzerra.

Meanwhile, in June 2019, Celgene’s (now a part of Bristol-Myers) regulatory applications seeking approval for its MS candidate, ozanimod, were accepted for review in the United States as well as in Europe with an approval in United States expected this year.

J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

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