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 debilitating disorder."
Vanda anticipates making HETLIOZ™ commercially available in the
second quarter of 2014.
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.
About HETLIOZ™
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™
Indication
HETLIOZ™ is indicated for the treatment of Non-24-Hour
Sleep-Wake Disorder (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.
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.
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
SOURCE Vanda Pharmaceuticals Inc.