Janssen, a subsidiary of Johnson & Johnson JNJ, announced that its pipeline candidate, ponesimod demonstrated superior efficacy to Sanofi’s SNY blockbuster multiple sclerosis (“MS”) drug, Aubagio, in a phase III study. The head-to-head late-stage OPTIMUM study evaluated 20 mg dose of ponesimod in patients with relapsing MS versus 14 mg dosage of Aubagio.
Data from the OPTIMUM study showed that ponesimod reduced annualized relapse rate in MS patients by statistically significant 30.5% compared to Aubagio up to 108 weeks following the treatment. The candidate also achieved a 56% reduction in cumulative number of combined unique active lesions compared to Sanofi’s drug. Data from the study was presented at the annual conference of The European Committee for Treatment and Research in Multiple Sclerosis held in Stockholm, Sweden.
J&J is planning to file regulatory applications in the United States and Europe for approval of ponesimod for treating relapsing forms of MS.
Share price of J&J has increased 1.6% against the industry’s decline of 2% year to date.
Please note that ponesimod was added to J&J’s pipeline with the June 2017 $30 billion acquisition of Swiss biotech, Actelion.
However, several companies are developing their candidates or commercializing drugs targeting relapsing MS. Sanofi itself has another drug, Lemtrada, for treating relapsing MS. Moreover, it is developing Aubagio for pediatric MS patients. However, Aubagio is set to face generic competition, starting 2023.
Novartis NVS successfully completed two late-stage studies evaluating its pipeline candidate, ofatumumab for the treatment of relapsing forms of MS last month. Ofatumumab also demonstrated superiority to Aubagio in clinical studies. Meanwhile, in June, Celgene’s CELG regulatory applications seeking approval for its MS candidate, ozanimod, were accepted for review in the United States as well as in Europe. Moreover, Biogen holds a strong position in the MS market with a wide range of products.
Ponesimod is likely to face competition from currently available therapies and upcoming branded as well generic drugs targeting MS.
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