Vanda Pharmaceuticals Inc. has recently announced the successful acquisition of the U.S. and Canadian rights to PONVORY® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company. This strategic move comes as PONVORY® holds approval from both the U.S. Food and Drug Administration (FDA) and Health Canada for the treatment of adults with relapsing forms of multiple sclerosis (RMS), encompassing clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. With a robust safety profile backed by over a decade of data, PONVORY® has demonstrated superiority over Aubagio®, another approved multiple sclerosis drug, in annual relapse rates. Furthermore, it is associated with fewer T2 and T1 MRI lesions compared to its counterpart, and about 9 out of 10 individuals taking PONVORY® did not experience disability progression over a span of two years.
Notably, the reversible effect of PONVORY® on circulating lymphocytes allows for a swift return to baseline levels after discontinuation, proving crucial for individuals requiring a therapy pause for vaccination. Additionally, for women of childbearing age seeking pregnancy, PONVORY® is eliminated from the body approximately seven days after treatment cessation.
Beyond its application in multiple sclerosis, PONVORY® exhibits promise as a therapeutic candidate for various inflammatory and autoimmune disorders, ranging from psoriasis to ulcerative colitis. Clinical studies have demonstrated its efficacy in reducing symptoms and signs of psoriasis.
The acquisition agreement involves a payment of $100 million by Vanda for the U.S. and Canadian rights to PONVORY®. During a Transitional Business License Agreement, Janssen will continue to operate the business, facilitating the smooth transition of regulatory and supply responsibilities for PONVORY® to Vanda.