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J&J advances MS drug candidate toward US, EU markets

  • An experimental drug developed by Johnson & Johnson for multiple sclerosis succeeded in a head-to-head study against Sanofi’s on-market therapy Aubagio, according to a Thursday statement from the pharma giant. 
  • Ponesimod, which J&J acquired via its $30 billion buyout of Actelion Pharmaceuticals two years ago, met the Phase 3 trial’s primary goal, which measured annualized relapse rates through two years. 
  • Detailed results were not disclosed, although J&J noted that the study also met “most” of its four secondary endpoints. Regulatory submissions in the U.S. and EU are planned for later this year, J&J said.

J&J’s 2017 deal to acquire Actelion centered on the Swiss biotech’s portfolio of drugs for a condition called pulmonary arterial hypertension. Ponesimod, already in late-stage development at the time, was largely a footnote.

But with a positive Phase 3 outcome now read out, the drug could help J&J rebuild its aging neuroscience business — a process begun with this year’s approval of depression drug Spravato (esketamine).

Unlike some of its pharma peers, J&J lacks a presence in multiple sclerosis, which by the drugmaker’s count is one of the most lucrative neuroscience markets. The highly competitive field is led by Biogen, Novartis, Sanofi and, most recently, Roche. 

Ponesimod is an S1P modulator, a class of drugs designed to limit the damage done to the protective sheaths surrounding nerve cells.

Novartis currently has two S1P modulators approved for multiple sclerosis, Gilenya (fingolimod) and the newer Mayzent (siponimod). A potential rival developed by Celgene, meanwhile, was a key pipeline asset attracting Bristol-Myers Squibb in its buyout of the large-cap biotech.  

In the Phase 3 study that J&J said succeeded, ponesimod was pitted against Sanofi’s Aubagio (teriflunomide). More than 1,100 patients with relapsing multiple sclerosis were enrolled in the trial, which lasted 108 weeks. 

No actual data of how ponesimod compared to Aubagio were released, but J&J said it would present results at the upcoming Congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Another large Phase 3 study, currently ongoing, compares ponesimod to placebo in patients treated with Biogen’s Tecfidera (dimethyl fumarate). 

Were J&J to win approval of ponesimod in relapsing multiple sclerosis, it would enter a market in transition. Roche’s success with its drug Ocrevus (ocrelizumab) has put pressure on incumbents like Biogen and Sanofi, and the pharma now estimates nearly four in 10 patients starting treatment receive its drug. 

Confidence among Roche executives is so high, in fact, a recent analyst question on the impact of new competitors on Ocrevus prompted a rare boast.

“We have seen an impact — the impact is that Ocrevus share goes up,” said Bill Anderson, head of Roche Pharmaceuticals, on a Thursday conference call, referring to the introduction of competing drugs from Novartis and Merck KGaA this year. 

“So, yes, we hope there are more competitive launches like that.”

For its part, J&J doesn’t appear to expect blockbuster sales from ponesimod, were it to be approved. A recent R&D presentation featuring ten experimental drugs J&J expected to deliver more than $1 billion in peak annual sales did not include ponesimod.