ROCKVILLE, Md., July 11, 2011 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical
company focused on the development and commercialization of
products for central nervous system disorders, today announced its
exclusive license agreement with Probiomed S.A. de C.V., a wholly
owned pharmaceutical operating unit of Proquifin S.A. de C.V., for
the commercialization of Fanapt™ in Mexico.
"We are very excited to achieve this step on the path towards
making Fanapt™ available in Mexico
and are very pleased to have Probiomed as our commercial partner,"
said Mihael H. Polymeropoulos, M.D.,
Vanda's Chief Executive Officer. "This marks an important
milestone for the Fanapt™ brand," added Dr. Polymeropoulos.
Probiomed's founder and CEO, Jaime
Uribe de la Mora, stated, "Fanapt™ represents a strategic
franchise opportunity for our company's neurosciences business
unit. We are very pleased to be Vanda's partner for Fanapt™
in Mexico. We expect to
submit the regulatory dossier for market authorization review by
the end of 2011."
Under the terms of the agreement, Probiomed will seek regulatory
approval for Fanapt™ in Mexico.
Vanda will supply Probiomed with Fanapt™ drug product for
sale and Probiomed's specialty sales force will promote Fanapt™ to
psychiatrists and commercialize the drug in Mexico.
With a market of $9.3 billion in
annual sales, Mexico is the second
largest pharmaceutical market in Latin
America and the 14th largest pharmaceutical market in the
world.(1)
(1) Source, IMS
About Probiomed
Probiomed is a privately owned Mexican company with more than 40
years of experience in research, development, manufacturing and
commercialization of pharmaceutical, biotechnology and vaccines for
human health. Probiomed's neuroscience expertise includes
development, manufacturing, sales and marketing of antipsychotics
and medicines to treat depression, anxiety and bi-polar diseases,
in addition to other central nervous system disorders.
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 Pharmaceuticals
Inc., 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/Investor Inquiries
Cristina Murphy
Cristina.murphy@vandapharma.com
240-599-4500
SOURCE Vanda Pharmaceuticals Inc.