WASHINGTON, Dec. 7, 2023
/PRNewswire/ -- 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.
Stifel acted as exclusive financial advisor to Vanda with
respect to this acquisition.
About PONVORY®
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
References
- Kappos L., Fox RJ., Burcklen M. (2021). Ponesimod Compared With
Teriflunomide in Patients With Relapsing Multiple Sclerosis in the
Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical
Trial. JAMA neurology, 78(5), 558–567.
https://doi.org/10.1001/jamaneurol.2021.0405
- Vaclavkova, A., Chimenti, S., Arenberger, P., Holló, P., Sator,
P. G., Burcklen, M., Stefani, M., & D'Ambrosio, D. (2014). Oral
ponesimod in patients with chronic plaque psoriasis: a randomised,
double-blind, placebo-controlled phase 2 trial. Lancet
(London,
England), 384(9959), 2036–2045.
https://doi.org/10.1016/S0140-6736(14)60803-5
- D'Ambrosio, D., Freedman, M. S., & Prinz, J. (2016).
Ponesimod, a selective S1P1 receptor modulator: a potential
treatment for multiple sclerosis and other immune-mediated
diseases. Therapeutic advances in chronic
disease, 7(1), 18–33.
https://doi.org/10.1177/2040622315617354
- Datamonitor Healthcare – Multiple Sclerosis (MS) Patient-Based
Market Forecast published October
2023 and Datamonitor Healthcare – Ulcerative Colitis
Patient-Based Market Forecast published March 2023.
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.
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 commercial success 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:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-acquires-us-and-canadian-rights-to-ponvory-ponesimod-a-selective-s1p1r-modulator-approved-for-patients-with-relapsing-multiple-sclerosis-302008402.html
SOURCE Vanda Pharmaceuticals Inc.