Actelion will grant rights for the drug in the US and Canadian regions to Vanda for $100m.
Janssen will progress business operations until the execution of a business licence agreement transfers the regulatory and supply responsibility of Ponvory to Vanda.
The US Food and Drug Administration (FDA) and Health Canada have approved the drug for RMS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
A once-a-day oral modulator of sphingosine-1-phosphate receptor 1 (S1P1R), Ponvory has an established safety profile with more than a decade of data.
The drug was demonstrated to be superior in the annual rate of multiple sclerosis relapse to another approved treatment, Aubagio, in a clinical trial.
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Nine out of ten individuals in the Ponvory arm did not have disability progression for more than two years.
Its effect on the reduction in circulating lymphocytes is reversible and lymphocyte levels can reach baseline following discontinuation of the treatment.
This quick reversible effect is vital for individuals who have to pause drug use to receive a vaccine or for women who intend to become pregnant.
Vanda president, CEO and board chairman Mihael Polymeropoulos stated: “The acquisition of Ponvory is a significant milestone for Vanda, as it expands our commercial portfolio and gives us access to a versatile immune response modifier that can potentially have broad application in treating a number of autoimmune-based disorders.”
The latest development comes after the FDA accepted the new drug application (NDA) filed by Vanda for tradipitant to treat gastroparesis.
Tradipitant is the first therapy to receive an FDA review for gastroparesis in more than 30 years.