WASHINGTON, April 9, 2014 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced the
availability of HETLIOZ™. HETLIOZ™ is the first treatment
approved by the U.S Food and Drug Administration (FDA) for
Non-24-Hour Sleep-Wake Disorder (Non-24), a serious chronic
circadian rhythm disorder that affects up to 70 percent of people
who are totally blind.
Vanda has launched HETLIOZSolutions™ to support
and facilitate the treatment of totally blind people living with
Non-24. HETLIOZSolutions™ will provide patients with
a host of resources including information about Non-24 and
HETLIOZ™, insurance support, overview of financial assistance
programs, and pharmacy access.
"The availability of HETLIOZ marks a major milestone for totally
blind people who have been without an approved, safe and effective
treatment for Non-24. We are also excited to bring a broad range of
services to patients through HETLIOZSolutions," said
Mihael H. Polymeropoulos, M.D.,
Vanda's President and Chief Executive Officer.
HETLIOZ™, which was approved by the FDA in January 2014, is available through specialty
pharmacies in the U.S.
About HETLIOZ™
Full HETLIOZ™ Prescribing Information and the Prescription and
Service Request form 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 potentially 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 Non-24-Hour Sleep-Wake Disorder
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. For more information on Non-24, please
visit www.Non-24.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.
U.S. full prescribing information for HETLIOZ™ is available
at www.HETLIOZ.com.
HETLIOZ™ is a trademark of Vanda Pharmaceuticals
Inc.
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 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, 2013, 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.
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.