ROCKVILLE, Md., July 26, 2011 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (NASDAQ: VNDA) announced today that the
European Medicines Agency (EMA) accepted for evaluation Vanda's
Marketing Authorization Application (MAA) for oral iloperidone
tablets. Iloperidone is an atypical antipsychotic for the
treatment of schizophrenia in adults.
"The submission in the European Union is an important milestone
towards advancing the iloperidone franchise," said Mihael H. Polymeropoulos, M.D., Vanda's
President and CEO. "This continues our efforts to expand the
availability of Fanapt® to markets outside the U.S. and
Canada."
Iloperidone is currently marketed in the U.S. by Novartis
Pharmaceuticals Corporation, an affiliate of Vanda's sublicensor
Novartis Pharma AG, under the name Fanapt®. Under a 2009
agreement, Novartis has exclusive rights relating to the
development and commercialization of iloperidone in the U.S. and
Canada. Under the terms of
such agreement, Vanda retained rights to commercialize iloperidone
oral and long-acting injectable formulations outside the U.S. and
Canada.
About Schizophrenia
Schizophrenia is a chronic, severe and disabling mental
disorder, characterized by profound disruptions in thinking,
affecting language, perception, and the sense of self. It often
includes psychotic experiences, such as hearing voices or
delusions. Schizophrenia typically begins in late adolescence or
early adulthood and affects approximately 5 million Europeans or
1.0% of the E.U. population.
About Fanapt®
Fanapt® belongs to a class of medications for schizophrenia
known as atypical antipsychotics. Fanapt® has been approved
by the U.S. Food and Drug Administration for the treatment of
schizophrenia in adults. For full U.S. prescribing information,
please visit www.fanapt.com.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company
focused on the development and commercialization of products for
central nervous system disorders. For more on Vanda, please visit
http://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," "targets," "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 the company's forward-looking statements
include, among others: the extent and effectiveness of the
development, sales and marketing and distribution support Fanapt®
receives; Vanda's ability to successfully commercialize Fanapt®
outside of the U.S. and Canada;
delays in the completion of Vanda's clinical trials; a failure of
Vanda's products, product candidates or partnered products to be
demonstrably safe and effective; Vanda's failure to obtain
regulatory approval for its products, product candidates or
partnered products or to comply with ongoing regulatory
requirements; a lack of acceptance of Vanda's products, product
candidates or partnered products in the marketplace, or a failure
to become or remain profitable; Vanda's expectations regarding
trends with respect to its costs and expenses; Vanda's inability to
obtain the capital necessary to fund additional research and
development activities; Vanda's failure to identify or obtain
rights to new products or product candidates; Vanda's failure to
develop or obtain sales, marketing and distribution resources and
expertise or to otherwise manage its growth; limitations on Vanda's
ability to utilize some or all of its prior net operating losses
and research and development credits; a loss of any of Vanda's key
scientists or management personnel; losses incurred from product
liability claims made against Vanda; a loss of rights to develop
and commercialize Vanda's products or product candidates under its
license and sublicense agreements 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, 2010 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.
Media Contact:
Cristina Murphy
+1-240-599-4500
cristina.murphy@vandapharma.com
SOURCE Vanda Pharmaceuticals Inc.