J&J's head-to-head PhIII data promise drug launch into crowded MS market
J&J announced positive data from a head-to-head Phase III trial squaring their S1P1 MS drug ponesimod against Sanofi’s Aubagio, setting up an FDA filing later this year and a possible 2020 launch into an increasingly crowded space.
A J&J launch will fly against steep headwinds. Novartis’s Mayzent (siponimod), tabbed by CEO Vas Narasimhan as a potential blockbuster, gained FDA approval in March based off a placebo study. The same month, Celgene re-filed its FDA application for ozanimod, leveraging data from a head-to-head trial against Avonex. And in August, TG Therapeutics announced positive results from its Phase II study of ublituximab, and Novartis announced positive results from their other MS drug Arzerra (ofatumumab) in its head-to-head trial against Aubagio.
J&J says it plans on moving forward with marketing applications in the US and Europe, and despite the crowded MS field, it would be the only direct rival to Novartis’s S1P Gilenya and Mayzent. Novartis announced today data from their Phase III EXPAND trial indicated Mayzent can help patients retain mobility for four years longer on average.
All of these drugs target relapsing forms of multiple sclerosis and will have to compete with Roche’s landmark blockbuster Ocrevus (ocrelizumab). It’ll be a limited competition, however; neither Novartis, Celgene nor TG has shown that their drugs are also effective as primary progressive treatments. That dual status is what helped propel Ocrevus to the top of the market.
J&J purchased ponesimod in their $30 billion Actelion buyout close to 3 years ago when they beat out Sanofi, whose management had insulted Actelion CEO, Jean-Paul Clozel, with “the tenor and content” of their negotiations.
The J&J study’s primary endpoint was annual relapse rate (ARR), as it was for Novartis and Celgene. They found an ARR of just over 20% for ponesimod, compared with 29% from Aubagio. The trial covered 1,133 participants over 108 weeks across 162 location. Data from Novartis’s head-to-head trial and TG Therapeutics’s Phase II are being presented this week.
The J&J drug also fared well in several secondary endpoints, including fatigue and cumulative number of combined unique active lesions found by MRI.
S1P drugs work by blocking lymphocyte immune cells from crossing the blood-brain barrier and damaging myelin, the fatty substance that surrounds nerve cells and that, in MS patients, is attacked by the body’s own immune system. Novartis’s Mayzent and the Celgene are also S1P drugs. Arzerra and the TG Therapeutics compounds are anti-CD20 drugs that target the CD20 receptor on the lymphocytes while they are circulating in the blood and before they cause inflammation in the nervous system. .
S1P drugs are also being investigated as a treatment for psoriasis.