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Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia
Date:10/12/2009

00 million for the exclusive rights to commercialize the oral tablet, which is already approved in the US, in the territory of the US and Canada, as well as to develop and commercialize a depot formulation of Fanapt for patients in this territory. Vanda will be eligible for additional payments upon achieving defined development and commercial milestones and will also receive sales royalties. Vanda will retain rights to develop and commercialize Fanapt outside the territory of US and Canada, but Novartis has the option to enter into discussions with Vanda to co-commercialize Fanapt or receive sales royalties outside this territory. The consummation of the transaction is subject to the receipt of customary regulatory approvals, which are expected by the end of 2009.

Important Safety Information

Fanapt is indicated for the acute treatment of schizophrenia in adults.

Increased Mortality: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. Fanapt is not approved for the treatment of patients with dementia-related psychosis.

QT Prolongation: In an open-label QTc study in patients with schizophrenia or schizoaffective disorder (N=160), Fanapt was associated with QTc prolongation of 9 msec at an iloperidone dose of 12 mg twice daily. This affect was augmented by the presence of CYP450, 2D6 or 3A4 metabolic inhibition. The use of Fanapt should be avoided in combination with other drugs that are known to prolong QTc. Caution is warranted when prescribing Fanapt with drugs that inhibit Fanapt metabolism.

Neuroleptic Malignant Syndrome (NMS):A potentially fatal symptom complex, has been reported in association with administration of antipsychotic drugs. Clinical manifestations include hyperpyrexia, muscle rigidity, altered mental sta
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SOURCE Novartis Pharmaceuticals Corporation
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