Vanda Pharmaceuticals has acquired U.S. and Canadian rights to PONVORY (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.
PONVORY is approved by the U.S. Food and Drug Administration (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.
“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,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board.
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.
The mechanism of action of PONVORY makes it also a potential therapeutic candidate for the treatment of a diverse group of inflammatory/autoimmune disorders ranging from psoriasis to ulcerative colitis. In a randomized placebo controlled clinical study, PONVORY has also been shown to reduce the symptoms and signs of psoriasis.
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.