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Vanda Pharmaceuticals, Inc.

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European Medicines Agency Accepts Fanaptum® (iloperidone) Marketing Authorization Application for the Treatment of Schizophrenia in Adults
WASHINGTON, Dec. 22, 2015 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that its Marketing Authorization Application (MAA) for oral Fanaptum® tablets has been accepted for evaluation by the European Medicines Agency (EMA) for the treatment of schizophrenia in adults.

"The MAA validation demonstrates Vanda's commitment to offer another option to the healthcare community to treat a severe, disabling mental disorder," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "This continues our efforts to expand the availability of iloperidone to people who we believe would benefit from this treatment option."

The MAA is primarily supported by data from two placebo- and active-controlled clinical trials and one long term randomized clinical trial. Fanaptum® was shown to be superior to placebo in controlling symptoms of schizophrenia.

Iloperidone is currently approved in the U.S. as Fanapt® for the treatment of schizophrenia in adults. Fanapt® is also approved and marketed in Israel and Mexico.
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Source: press release, 12/22/15. http://phx.corporate-ir.net/phoenix.zhtml?c=196233&p=irol-newsArticle&ID...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Fanapt (Iloperidone) PsychiatrySchizophreniaAntipsychotic (atypical)5-HT2c serotonin receptor

Mechanism of action: Fanapt (Iloperidone), a SM atypical anti-psychotic, has activity on both dopamine and serotonin receptors with a low binding affinity to the dopamine D2 receptor and high affinity for the 5-HT2 receptor.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-12-16

Results: Pending