Vanda Announces Trial Date for Fanapt® Patent Cases

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Apr 13, 2015, 05:45 ET

WASHINGTON, April 13, 2015 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced a February 29, 2016 trial date for two pending cases against Roxane Laboratories Inc. regarding Roxane's submission of an Abbreviated New Drug Application (ANDA) to obtain approval to make and sell generic Fanapt^® (iloperidone oral tablets). The two cases, C.A. No. 14-757 (D. Del.) and C.A. No. 13-1973 (D. Del.), have been consolidated by agreement of the parties and are scheduled to be tried together in a four-day bench trial beginning on February 29, 2016.

In C.A. No. 14-757-GMS, Vanda is asserting U.S. Patent No. 8,586,610 ('610 patent), covering methods of treating schizophrenia by administering Fanapt^® to certain patients, while in C.A. No. 13-1973-GMS, Vanda is asserting the U.S. composition of matter patent for Fanapt^®, U.S. Patent No. RE39,198 (the RE'198 patent). Both patents are listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The '610 patent expires November 2027 and the RE'198 patent expires November 2016.

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.

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this release 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 statements include, among others, Vanda's assumptions regarding the life of the Fanapt^® patents 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, 2014, 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

Corporate Contact:
Jim Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
[email protected]

Media Contact:
Laney Landsman
Vice President
Makovsky
(212) 508-9643
[email protected]

SOURCE Vanda Pharmaceuticals Inc.