WASHINGTON, Aug. 1, 2016 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that
HETLIOZ® (tasimelteon) is now available for the treatment of
Non-24-Hour Sleep-Wake Disorder (Non-24) in Germany.
"The launch of HETLIOZ in Germany reflects our continued focus to bring
a treatment option to Non-24 patients across the globe," said
Gian Piero Reverberi, Vanda's Senior
Vice President and Chief Commercial Officer. "We are very pleased
with our first HETLIOZ launch outside of the United States and look forward to making
HETLIOZ available in additional countries in the coming years."
In July 2015, the European
Commission (EC) approved HETLIOZ® for the treatment of Non-24 in
totally blind adults in all 28 European Union (EU) member states as
well as European Economic Area members Iceland, Liechtenstein and Norway.
About Non-24-Hour Sleep-Wake Disorder
Non-24 is a chronic, circadian rhythm disorder resulting from the
misalignment of the endogenous master body clock to the 24-hour
day, disrupting the sleep-wake cycle. The sleep disturbance causes
significant distress or impairment in social, occupational and
other important areas of functioning.
About HETLIOZ®
HETLIOZ® is a melatonin receptor agonist. HETLIOZ® has been
approved by the EC and received orphan drug designation for the
treatment of Non-24 in totally blind adults in the EU. For full EU
prescribing information, please visit http://www.ema.europa.eu.
HETLIOZ® has been approved by the U.S. Food and Drug
Administration and received orphan drug designation for the
treatment of Non-24. For full U.S. prescribing information,
please visit www.hetlioz.com.
U.S. Indication and Important Safety Information About
HETLIOZ®
Indication
In the U.S., HETLIOZ® is indicated for the treatment of Non-24.
Important Safety Information
HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients
should limit their activity to preparing for going to bed, because
HETLIOZ® can impair the performance of activities requiring
complete mental alertness.
The most common adverse reactions (incidence >5% and at least
twice as high on HETLIOZ® than on placebo) were headache, increased
alanine aminotransferase, nightmares or unusual dreams, upper
respiratory or urinary tract infection. The risk of adverse
reactions may be greater in elderly (>65 years) patients than
younger patients because exposure to HETLIOZ® is increased by
approximately 2-fold compared with younger patients.
Use of HETLIOZ® should be avoided in combination with
fluvoxamine or other strong CYP1A2 inhibitors, because of a
potentially large increase in exposure of HETLIOZ®, and a greater
risk of adverse reactions. HETLIOZ® should be avoided in
combination with rifampin or other CYP3A4 inducers, because of a
potentially large decrease in exposure of HETLIOZ®, with reduced
efficacy.
There are no adequate and well-controlled studies of HETLIOZ® in
pregnant women. Based on animal data, HETLIOZ® may cause fetal
harm. HETLIOZ® should be used during pregnancy only if the
potential benefit justifies the potential risks. Caution should be
exercised when HETLIOZ® is administered to a nursing woman.
HETLIOZ® has not been studied in patients with severe hepatic
impairment and is not recommended in these patients.
Safety and effectiveness of HETLIOZ® in pediatric patients have
not been established.
About Vanda Pharmaceuticals Inc.
Vanda is a specialty
pharmaceutical company focused on the development and
commercialization of novel therapies to address high unmet medical
needs and improve the lives of patients. For more on Vanda
Pharmaceuticals, please visit www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release are "forward-looking statements"
under the securities laws. Forward-looking statements are based
upon current expectations that involve risks, changes in
circumstances, assumptions 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 (alone or
with others) HETLIOZ® in additional countries and other factors
that are described in the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's annual report on Form 10-K for the
fiscal year ended December 31, 2015
and quarterly report on Form 10-Q for the quarter ended
June 30, 2016, which are on file with
the SEC and available on the SEC's website at www.sec.gov. In
addition to the risks described above and in Vanda's annual report
on Form 10-K and quarterly reports on Form 10-Q, other unknown or
unpredictable factors also could affect Vanda's results. There can
be no assurance 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.
Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
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 release is provided
only as of the date of this 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.
HETLIOZ® is a registered trademark of Vanda Pharmaceuticals
Inc.
Corporate Contact:
Jim Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Laney Landsman
Assistant Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com
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SOURCE Vanda Pharmaceuticals Inc.