WASHINGTON, Jan. 25,
2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and
Trademark Office has issued a notice of allowance for its
PONVORY® (ponesimod) patent application, number
17/962,968, covering methods for reducing clinical management
events before or during the treatment of multiple sclerosis and
methods for reinitiating treatment after missed doses. When issued,
this patent is anticipated to expire on October 10, 2042. Upon issuance, Vanda intends to
list this patent in the U.S. Food and Drug Administration
publication Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly known as the Orange Book.
Vanda acquired rights to U.S. and Canadian rights to
PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a
Johnson & Johnson Company. PONVORY® is approved
by the U.S. Food and Drug Administration and Health Canada to treat
adults with relapsing forms of multiple sclerosis, to include
clinically isolated syndrome, relapsing-remitting disease and
active secondary progressive disease.
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 Twitter @vandapharma.
About PONVORY®
PONVORY® (ponesimod) is a daily oral selective
sphingosine-1-phosphate receptor 1 (S1P1R) modulator, indicated to
treat adults with relapsing forms of multiple sclerosis, 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 www.ponvory.com. The
PONVORY® Orange Book listed patent with the latest
expiry date is set to expire in December
2035.
About Multiple Sclerosis
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.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not
limited to statements regarding the USPTO's plans to issue the new
PONVORY® patent, the anticipated life of the patent and
Vanda's intentions to list the patent in the Orange Book, 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, the payment by Vanda to the USPTO
of all fees required prior to the issuance of the patent, the
ultimate issuance of the patent by the USPTO and Vanda's ability to
protect its intellectual property rights and defend the new
PONVORY® patent against any attempt to invalidate it.
Therefore, no assurance can be given that the actual 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 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:
Kevin
Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.