Vanda Pharmaceuticals Announces Completion of Transfer of FDA Marketing Authorization for PONVORY®
Vanda Pharmaceuticals announced the completion of the transfer of the U.S. New Drug Application and Investigational New Drug Applications for PONVORY® (ponesimod) from a Johnson & Johnson Company on May 30, 2024. This milestone enables Vanda to fully commercialize PONVORY® in the U.S. and commence clinical development programs. PONVORY® is approved by the FDA and Health Canada for treating adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease (RMS). Vanda acquired U.S. and Canadian rights to PONVORY® on December 7, 2023. In preparation for a Q3 2024 commercial launch, Vanda is creating a specialty sales force, a prescriber awareness program, and a comprehensive marketing strategy.
- Completion of FDA marketing authorization transfer for PONVORY®.
- Vanda can now fully commercialize PONVORY® in the U.S.
- Initiating clinical development programs for PONVORY®.
- PONVORY® is FDA and Health Canada approved for treating RMS.
- Vanda is preparing a specialty sales force and marketing strategy for Q3 2024 launch.
- No immediate revenue generation as PONVORY® launch is planned for Q3 2024.
- High initial costs for creating a specialty sales force and marketing strategy.
- Dependence on successful commercialization and market acceptance of PONVORY®.
The transfer of FDA marketing authorization for PONVORY® to Vanda Pharmaceuticals marks a significant strategic move for the company. Financially, this means Vanda now fully controls the commercial potential of this drug, which can directly impact its revenue streams. The planned commercial launch in Q3 2024 and subsequent marketing activities are likely to increase expenses in the short term. However, if executed well, these initiatives could drive substantial revenue growth in the long term.
Investors should note that while this asset acquisition can diversify and strengthen Vanda’s portfolio, it also comes with inherent risks, such as market competition and the effectiveness of their commercialization strategy. It’s important to monitor how well Vanda executes its market entry and manages its operational costs.
Rating: 1
The pharmaceutical market for treatments of relapsing forms of multiple sclerosis (RMS) is highly competitive, featuring established players with significant market shares. PONVORY® holds potential as it addresses a spectrum of conditions under RMS, but Vanda’s success will hinge on its capability to differentiate this drug from others in the market through effective marketing and educating prescribers.
The creation of a specialty sales force and prescriber awareness program is a strategic move to build a strong market presence. However, the effectiveness of these initiatives will depend on Vanda’s ability to convey the clinical benefits of PONVORY® effectively and capture a significant share of the market. Investors should watch for updates on market penetration and sales metrics post-launch.
Rating: 1
"This milestone completes the transfer of the FDA marketing authorization to Vanda and allows Vanda to commence full commercialization efforts and begin clinical development programs as we seek to maximize the potential of Ponvory in the treatment of a host of inflammatory disorders," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.
Vanda acquired
In anticipation of the commercial launch of PONVORY® for RMS in the third quarter of 2024, Vanda is initiating a host of commercial activities including the creation of a specialty sales force, a prescriber awareness program and a comprehensive marketing program.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
About PONVORY®
Vanda acquired
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, statements regarding Vanda's commercial and clinical development plans for PONVORY® and the initiation of commercial activities are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to execute the commercial launch of PONVORY® in the
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Corporate Contact:
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Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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Collected Strategies
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SOURCE Vanda Pharmaceuticals Inc.
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