Full Press Release Details
Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to
PONVORY (ponesimod), a Selective S1P1R Modulator Approved for Patients with Relapsing Multiple Sclerosis
WASHINGTON, December 7, 2023 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it 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).1
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.2
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.
exclusive financial advisor to Vanda with respect to this acquisition.
PONVORY (ponesimod) is a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator, indicated to treat adults with relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease and active secondary
progressive disease. PONVORY blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. PONVORY does not require genetic testing or first-dose cardiac monitoring for most patients. Because initiation of PONVORY treatment results in a
decrease in heart rate, first-dose monitoring is recommended in patients with certain preexisting cardiac conditions. For full U.S. Prescribing Information for PONVORY , including Important
Safety Information, visit https://www.ponvory.com/.
The PONVORY Orange Book listed
patent with the latest expiry date is set to expire in December 2035.
About Multiple Sclerosis
MS is a chronic autoimmune inflammatory disease of the central nervous system (CNS) in which immune cells attack myelin (the protective casing that insulates
nerve cells), damaging or destroying it and causing inflammation. This affects how the CNS processes information and communicates with the rest of the body, causing the neurologic signs and symptoms of MS. Symptoms vary by person, but common
symptoms include fatigue, balance and walking problems, numbness or tingling, dizziness and vertigo, vision problems, bladder and bowel problems and weakness.
About Sphingosine-1-Phosphate Receptor 1 Modulators
PONVORY (ponesimod) belongs in the molecular class of sphingosine-1-phosphate (S1P) analogs that act as modulators of the S1P receptor (S1PR). There are five S1PR (1-5) subtypes with different tissue distribution and
functional specificity. PONVORY is a selective ligand for the S1P1R subtype. It has been speculated that selectivity for S1P1R, rapid onset and reversibility of pharmacological effects, and
an optimized titration regimen may differentiate ponesimod from fingolimod, the first of the oral S1PR modulators in the treatment of multiple sclerosis, and may lead to better safety and
tolerability.3 Besides fingolimod (FDA approved in 2010), there are four additional FDA-approved members in the S1P modulator class that include siponimod
(2019), ozanimod (2020), ponesimod (2021) and etrasimod (2023). With the exception of etrasimod, all other drugs are currently approved for the treatment of MS. Ozanimod and etrasimod are approved for the treatment of ulcerative colitis.
The S1PR modulators act by preventing the egress of lymphocytes from the lymph nodes and as such reduce the number of circulating lymphocytes leading to a
decrease of the autoimmune response at the target site.
Based on the latest Datamonitor market forecasts for multiple sclerosis and ulcerative colitis,
the S1P market in the U.S. is expected to be approximately $2 billion in 2024 and to grow to approximately $3.5 billion in 2028.4
About Vanda Pharmaceuticals
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to statements regarding the impact that the acquisition of PONVORY will have on Vanda s commercial portfolio, the potential of PONVORY to treat a diverse group of inflammatory/autoimmune disorders,
the post-closing transitional plans to operate the U.S. and Canadian PONVORY business during the transition period, the parties plans to transition regulatory and supply responsibility
for PONVORY to Vanda, the duration of the patent protection for PONVORY , the potential differentiation of PONVORY from other drugs in its class, the safety and tolerability of PONVORY , and the size and growth of the potential U.S. market for the class
of S1P1R modulators 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 successfully commercialize PONVORY , the results of any clinical trials conducted for PONVORY in
the treatment of other inflammatory/autoimmune disorders and Vanda s ability to obtain regulatory approval of PONVORY for any such additional indications, the seller s ability to
effectively operate the U.S. and Canadian PONVORY business during the transition period, the parties ability to transition regulatory and supply responsibility for PONVORY to Vanda, the ability of the parties to successfully defend any challenge to the PONVORY patents, the ability of the identified
characteristics of PONVORY and an optimized titration regimen to differentiate it from other drugs in its class and result in better safety and tolerability, and the market acceptance and
of S1P1R modulators. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the
expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda s business and market, particularly those identified in the
Cautionary Note Regarding Forward-Looking Statements , Risk Factors and Management s Discussion and Analysis of Financial Condition and Results of Operations sections of Vanda s most recent Annual Report
on Form 10-K, as updated by Vanda s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings
with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
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 Current Report on Form 8-K 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.
Vanda Corporate Contact:
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals Inc.