Juvisé to market, develop Ponvory outside North America
Therapy outperformed Aubagio in Phase 3 OPTIMUM study
The French company Juvisé Pharmaceuticals has acquired the rights to develop and market the approved multiple sclerosis (MS) therapy Ponvory (ponesimod) outside the U.S. and Canada.
The global rights were acquired from Actelion Pharmaceuticals, the therapy’s original developer and now part of Johnson & Johnson Innovative Medicine. Juvisé will work closely with Johnson & Johnson to ensure the transition is smooth and that Ponvory remains available to patients. The medication will be produced in France and Switzerland.
“We are very excited about Ponvory and its potential to have a very positive impact on the lives of patients with multiple sclerosis,” Frédéric Mascha, founder and president of Juvisé Pharmaceuticals, said in a company press release.
The transaction was funded as a result of the French sovereign fund Bpifrance and Pemberton Asset Management, a private credit manager in Europe, acquiring a minority stake in Juvisé. Financial details from the transactions weren’t disclosed.
The company will use its expertise to develop and market Ponvory, with a focus on Europe, where the medication is available in 30 countries for adults with relapsing forms of MS and active disease, as defined by certain clinical or imaging features.
“We are proud to establish a new partnership with a major pharmaceutical company and to have two strong partners such as Bpifrance and Pemberton enter our capital to support our future growth,” Mascha said.
What is Ponvory?
Ponvory reduces brain and spinal cord inflammation by trapping immune cells inside lymph nodes, small organs where immune cells are matured and kept stored.
This reduces the amount of immune cells that reach the brain to cause inflammation, lowering the risk of relapses and slowing the development of lesions.
The therapy was first approved in the U.S. in March 2021, where it’s indicated for adults with relapsing forms of MS, including relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), or clinically isolated syndrome. The approval in the European Union came in May of the same year for adults with relapsing forms of MS and active disease.
The approvals were supported by data from the Phase 3 OPTIMUM trial (NCT02425644), which compared the safety and effectiveness of Ponvory against Aubagio (teriflunomide), an older oral disease-modifying therapy (DMT) approved for MS.
The results confirmed Ponvory’s superiority at lowering relapse rates, reducing the number of new disease lesions, and easing fatigue. No differences were seen regarding disability progression, although very few patients on either treatment experienced it.
Based on the findings, Ponvory became the first oral MS treatment to significantly improve outcomes compared with Aubagio in a head-to-head trial, Juvisé said in its press release.
“This acquisition is a strategic step for Juvisé as it expands our portfolio with the first patent protected product with strong development potential over the coming years. It is in line with what we have been doing for the past 16 years, which is providing essential medications to patients and specialist doctors,” Masha said.
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