WASHINGTON, May 30, 2024
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today announced that ownership of the U.S. New Drug Application and
Investigational New Drug Applications for PONVORY®
(ponesimod) has been transferred to Vanda from a Johnson &
Johnson Company, which now fully allows Vanda to commercialize
PONVORY® in the U.S.
"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 U.S. and Canadian rights to PONVORY®
from a Johnson & Johnson Company on December 7, 2023. PONVORY® is
approved by the U.S. Food and Drug Administration (FDA) 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 (RMS).
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 U.S. and Canadian rights to PONVORY®
from Actelion Pharmaceuticals Ltd., a Johnson & Johnson Company
on December 7, 2023.
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.ponvoryus.com. The
PONVORY® Orange Book listed patent with the latest
expiry date is set to expire in October
2042.
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 U.S.
in the third quarter of 2024 and initiate its clinical development
program for PONVORY® in the treatment of inflammatory
disorders other than RMS, the results of any clinical trials
conducted for PONVORY® in the treatment of such
disorders, and Vanda's ability to obtain regulatory approval of
PONVORY® for any such disorders and Vanda's ability to
successfully create a specialty sales force, a prescriber awareness
program and a comprehensive marketing program for
PONVORY®. 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 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
Jim Golden / Jack Kelleher / Dan
Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.