August 1, 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
-based Biotoscana Farma S.A., a wholly owned affiliate of Biotoscana International, based in
, for the commercialization of Fanapt ™ in
"We are very excited to achieve this step on the path towards making Fanapt ™ available in
and we are very pleased to have Biotoscana as our commercial partner," said
Mihael H. Polymeropoulos
, M.D., Vanda's Chief Executive Officer. "This marks another important milestone for the Fanapt ™ brand as we continue to grow our presence with Fanapt ™ in
," added Dr. Polymeropoulos. Biotoscana's co-founder and CEO,
Ridau, stated, "We are very pleased to partner with Vanda in
with Fanapt ™. Our recently submitted regulatory filing for marketing authorization for Fanapt ™ marks the first step in the process towards the commercial launch of Fanapt™ in
Under the terms of the agreement, Biotoscana will seek regulatory approval for Fanapt ™ in
. Vanda will supply Biotoscana with Fanapt ™ drug product for packaging and sale and Biotoscana's CNS specialty sales force will promote Fanapt ™ to psychiatrists in
in annual sales,
is the 4th largest pharmaceutical market in
(1) Source, IMS/MIDAS, CID Latina
About Biotoscana S.A. and Biotoscana Farma S.A.
Biotoscana International ("Biotoscana") is a privately owned company formed in
in 1995. Through a number of strategic company acquisitions and growth through global licensing partnerships, today Biotoscana is a multinational pharmaceutical company with operating affiliates throughout
. Biotoscana Farma S.A. was formed in
For more on Biotoscana S.A., please visit
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
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
; 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
. 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.