WASHINGTON, Sept. 10, 2015 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a
favorable Markman ruling has been issued by the United States
District Court for the District of Delaware in the patent infringement lawsuit
filed by Vanda against Roxane Laboratories Inc. (Roxane) regarding
Roxane's submission of an Abbreviated New Drug Application to make
and sell a generic version of Fanapt®.
A Markman ruling, also known as a Claim Construction Ruling, is
a court ruling in which the judge determines the meaning of key
terms from certain disputed patent claims. The Delaware court, which was asked to construe
disputed patent claim terms in U.S. Patent number 8,586,610 ('610),
rejected Roxane's proposed construction of all the disputed claim
terms. The '610 patent is expected to expire in November 2027.
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.
About Fanapt®
Fanapt® is
an atypical antipsychotic agent indicated for the treatment of
schizophrenia in adults. In choosing among treatments, prescribers
should consider the ability of Fanapt® to prolong the QT
interval and the use of other drugs first. Prescribers should also
consider the need to titrate Fanapt® slowly to avoid orthostatic
hypotension, which may lead to delayed effectiveness compared to
some other drugs that do not require similar titration.
IMPORTANT WARNINGS and PRECAUTIONS: increased mortality in
elderly patients with dementia-related psychosis; QT prolongation;
neuroleptic malignant syndrome; tardive dyskinesia; hyperglycemia
and diabetes mellitus; weight gain; seizures; orthostatic
hypotension and syncope; leukopenia, neutropenia and
agranulocytosis; hyperprolactinemia; body temperature regulation;
dysphagia; suicide; priapism; potential for cognitive and motor
impairment.
COMMONLY OBSERVED ADVERSE REACTIONS of FANAPT®
(>=5% and 2x placebo): dizziness, dry mouth, fatigue, nasal
congestion, orthostatic hypotension, somnolence, tachycardia, and
weight increased.
For full US Prescribing Information, including Boxed Warnings
and Important Safety Information, visit our Web site at
www.fanapt.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING
STATEMENTS
Various statements in this release, including,
without limitation, statements regarding the expiration of the '610
patent, 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
are set forth 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, 2014 and quarterly report on
Form 10-Q for the quarter ended June
30, 2015, 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.
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
Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com
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SOURCE Vanda Pharmaceuticals Inc.