Vanda Pharmaceuticals acquires U.S. and Canadian rights to Ponvory (ponesimod), a selective S1P1R modulator, approved for patients with relapsing multiple sclerosis.

Ponvory is approved by the FDA and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Ponvory has a proven safety profile with over 10 years of data.

In a clinical study, Ponvory was shown to be superior to Aubagio, another approved drug for multiple sclerosis (MS), in the annual rate of relapse and it was also associated with fewer T2 and T1 MRI lesions versus the comparator. Approximately 9 out of 10 people taking Ponvory did not experience disability progression over 2 years (as measured by the time to 3-month Confirmed Disability Progression). The effect of Ponvory on the decrease of circulating lymphocytes is reversible so lymphocytes quickly return to baseline levels after discontinuation of Ponvory. This rapid reversible effect is important for people needing to pause therapy for a vaccine. For women of childbearing age who want to become pregnant, Ponvory is eliminated from the body in about 7 days after stopping treatment.

Under the terms of the agreement, Vanda paid $100 million to acquire the U.S. and Canadian rights to Ponvory. Janssen will continue to operate the business pursuant to a Transitional Business License Agreement, during which time, Vanda and Janssen will transition regulatory and supply responsibility for Ponvory to Vanda.