ROCKVILLE, Md., Dec. 13, 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 Megapharm Ltd., one of Israel's leading private biotech, pharmaceutical and medical nutrition marketing companies, for the commercialization of Fanapt™ in Israel.
"We are excited to reach this step on the path towards making Fanapt™ available in Israel and pleased to have Megapharm as a 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 its presence around the world," added Dr. Polymeropoulos. Megapharm's CEO, Miron Drucker, stated, "we are delighted to have concluded an agreement with Vanda Pharmaceuticals for the marketing of Fanapt™ in Israel. We have been active in the CNS field for many years and are excited to have the opportunity to launch such an important antipsychotic product. This is also an important step in the company's strategy to strengthen our presence and expand our portfolio in this therapeutic area. We are proud that Vanda has chosen us to introduce such an important treatment option for patients who suffer from the symptoms of Schizophrenia."
Under the terms of the agreement, Megapharm will seek regulatory approval for Fanapt™ in Israel. Vanda will supply Megapharm with Fanapt™ drug product for packaging and sale and Megapharm's CNS specialty sales force will promote Fanapt™ to psychiatrists in Israel. The application for regulatory approval of Fanapt™ in Israel was filed in May 2011.
About MegapharmMegapharm Ltd. is one of the leading private biotech, pharmaceutical and medical nutrition marketing companies in Israel with a strong biotech orientation, exclusively representing a number of major American and European pharmaceutical companies. Megapharm has demonstrated dynamic sales growth by developing a strong company presence and expertise in select therapeutic areas and diversified segments of the healthcare business. For more information see www.megapharm.co.il. 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.
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