FDA Approves HETLIOZ™ (tasimelteon) for the Treatment of Non-24-Hour
Non-24 is highly prevalent among the totally blind
WASHINGTON, Jan. 31, 2014
WASHINGTON, Jan. 31, 2014 /PRNewswire/ --Vanda Pharmaceuticals Inc. (VANDA)
(NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration
(FDA) has approved HETLIOZ™ (tasimelteon) 20mg capsules for the treatment of
Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ™ is the first FDA approved
medication for Non-24.
Non-24 was first described more than 60 years ago, and 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. Non-24 affects the
majority of totally blind individuals and it is estimated that approximately
80,000 Americans have the disorder.
"The FDA approval of HETLIOZ™ would not have been accomplished without the
heroic efforts of blind patients and their advocates," said Mihael H.
Polymeropoulos, M.D., Vanda's President and Chief Executive Officer. "We are
committed to providing much needed support to patients with Non-24 and
facilitating access to this new therapeutic option."
The approval of HETLIOZ™ was based on two key efficacy studies and the safety
has been evaluated in over 1,300 individuals.
The most common adverse reactions in the clinical trials were headache,
increased alanine aminotransferase, nightmares or unusual dreams, upper
respiratory or urinary tract infection. 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.
"Totally blind people have struggled with the problems brought on by
Non-24-Hour Sleep-Wake Disorder, sometimes for their entire life, without
understanding what causes it and without being able to do anything about it,"
said Steven W. Lockley, Ph.D., Division of Sleep Medicine, Brigham and Women's
Hospital, a teaching affiliate of Harvard Medical School. "Today's FDA
approval of HETLIOZ™ means that, for the first time, these patients have
access to an approved, safe and effective treatment for their difficult
Vanda anticipates making HETLIOZ™ commercially available in the second quarter
Conference Call for Investors
Vanda Pharmaceuticals will host a conference call for investors, Monday,
February 3, 2014 at 10:00 AM ET, to discuss the FDA's approval of HETLIOZ™.
Investors can call 1-888-895-5271 (domestic) and 1-847-619-6547
(international) and use passcode 36581091. A replay of the call will be
available beginning Monday, February 3, 2014 at 12:30 PM ET and will be
accessible until Monday, February 10, 2014, at 11:59 PM ET. The replay
call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for
international callers. The access number is 36581091.
The conference call will be broadcast simultaneously on Vanda's website,
www.vandapharma.com. Investors should click on the Investor Relations tab and
are advised to go to the website at least 15 minutes early to register,
download, and install any necessary software or presentations. The call will
also be archived on Vanda's website for a period of 30 days.
Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com
For more information about HETLIOZ™ call 1-844-HETLIOZ (1-844-438-5469).
Indication and Important Safety Information About HETLIOZ™
HETLIOZ™ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder
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
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
Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of products for the treatment of central
nervous system disorders. For more on Vanda, please visit www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release are "forward-looking statements" under the
securities laws. Words such as, but not limited to, "believe," "expect,"
"anticipate," "estimate," "intend," "plan," "project," "target," "goal,"
"likely," "will," "would," and "could," or the negative of these terms and
similar expressions or words, identify forward-looking statements.
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 the
U.S., uncertainty as to the market awareness of Non-24 and the market
acceptance of HETLIOZ™, Vanda's dependence on third-party manufacturers to
manufacture HETLIOZ™ in sufficient quantities and quality, Vanda's limited
sales and marketing infrastructure, 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, 2012 which is 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.
U.S. full prescribing information for HETLIOZ™ is available at www.HETLIOZ.com
HETLIOZ™ is a registered trademark of Vanda Pharmaceuticals Inc.
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
Assistant Vice President
SOURCE Vanda Pharmaceuticals Inc.
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