Vanda Pharmaceuticals Completes FDA Marketing Authorization Transfer for PONVORY®

Vanda Pharmaceuticals Inc., a prominent biopharmaceutical company, announced a significant development on May 30, 2024. The company has gained ownership of the U.S. New Drug Application and Investigational New Drug Applications for PONVORY® (ponesimod) from a Johnson & Johnson Company. This transfer enables Vanda to fully commercialize PONVORY® within the United States.

"This milestone finalizes the FDA marketing authorization's transfer to Vanda, allowing us to initiate comprehensive commercialization strategies and begin clinical development programs aimed at exploiting Ponvory's full potential in treating various inflammatory disorders," stated Mihael H. Polymeropoulos, M.D., President, CEO, and Chairman of Vanda.

Vanda purchased the U.S. and Canadian rights to PONVORY® on December 7, 2023, from a Johnson & Johnson Company. PONVORY® has received approval from the U.S. Food and Drug Administration (FDA) and Health Canada for treating adults with relapsing forms of multiple sclerosis (RMS). This includes conditions such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

In preparation for the commercial launch of PONVORY® for RMS in the third quarter of 2024, Vanda is deploying several key initiatives. These include establishing a specialized sales team, launching a prescriber awareness program, and implementing an extensive marketing campaign.

Vanda Pharmaceuticals Inc. has established itself as a global leader in the biopharmaceutical sector. The company focuses on developing and commercializing innovative therapies to meet high unmet medical needs and enhance patients' lives.

PONVORY®, developed by Actelion Pharmaceuticals Ltd., a subsidiary of Johnson & Johnson, is a daily oral medication that selectively modulates sphingosine-1-phosphate receptor 1 (S1P1R). This drug is specifically designed to treat adults with relapsing forms of multiple sclerosis. By inhibiting lymphocytes from exiting lymph nodes, PONVORY® reduces lymphocyte levels in the peripheral blood. The medication does not require genetic testing or initial cardiac monitoring for most patients. However, due to the potential for a decreased heart rate at the start of treatment, first-dose monitoring is recommended for patients with specific preexisting cardiac conditions.

Vanda has taken a cautious approach regarding forward-looking statements in their latest press release. These statements encompass Vanda's plans for commercial and clinical development of PONVORY®, including the initiation of various commercial activities. It's essential to note that forward-looking statements are based on current expectations and assumptions, which involve risks, changes, and uncertainties.

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