Vanda Pharmaceuticals Steps Up in the Fight Against Multiple Sclerosis

Introduction

Vanda Pharmaceuticals Inc. has announced the successful transfer of FDA marketing authorization for PONVORY® (ponesimod), a treatment for various forms of multiple sclerosis (MS), from a Johnson & Johnson company. The transfer represents a significant milestone, enabling Vanda to fully commercialize the drug in the United States.

What is PONVORY®?

PONVORY® is a selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator taken daily as an oral medication. It is designed to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

The drug works by blocking lymphocytes from leaving the lymph nodes, which reduces their numbers in the peripheral blood. This activity helps to manage the immune response that causes the relapses in MS.

The Significance of FDA Transfer

The FDA transfer of PONVORY® marks a pivotal development for Vanda. This transfer means that Vanda now holds the U.S. New Drug Application and Investigational New Drug Applications, allowing them to proceed with full commercialization and the start of new clinical development programs.

According to Mihael H. Polymeropoulos, M.D., President, CEO, and Chairman of Vanda, the milestone supports efforts to maximize Ponvory's potential in treating a variety of inflammatory disorders, beyond MS.

Commercialization Efforts Begin

Vanda has announced the launch of various commercial activities to prepare for PONVORY®'s wide release in the U.S. market. These include establishing a specialty sales force, creating prescriber awareness programs, and implementing comprehensive marketing initiatives.

The company aims to deliver these efforts in time for the expected commercial launch in the third quarter of 2024.

PONVORY®: A Future-Ready Medication

One of the key advantages of PONVORY® is that it does not require genetic testing or first-dose cardiac monitoring for most patients. However, for those with certain preexisting heart conditions, first-dose monitoring is still recommended due to the drug's impact on heart rate.

The product's Orange Book listed patent is set to expire in October 2042, giving Vanda a long runway to maximize its commercial potential.

About Vanda Pharmaceuticals

Vanda is a global biopharmaceutical company recognized for developing and commercializing innovative treatments for unmet medical needs. The acquisition of PONVORY® enables Vanda to expand its portfolio and strengthen its position in the healthcare market.

Regulatory & Forward-Looking Statements

Vanda's announcement includes statements about future prospects, such as the anticipated success of PONVORY®'s launch and clinical trials for other indications. However, these forward-looking statements carry risks and uncertainties. Actual outcomes may differ, and it is crucial for stakeholders to consider these factors rationally.

Investors are advised to review the risks listed in Vanda's recent Annual and Quarterly Reports.

Contact Information

For more details on Vanda Pharmaceuticals Inc. and their initiatives, you can visit their official website or reach out to their corporate contacts provided in the announcement.