Novartis Enters Into Agreement With Vanda

Published: 13-Oct-2009

Addition of the FDA approved oral therapy for Schizophrenia, Fanapt to strengthen Novartis psychiatry portfolio

Novartis has entered into an agreement for exclusive US and Canadian rights to Fanapt(iloperidone), a new oral medication that is approved by the US Food and Drug Administration (FDA) for the acute treatment of adults with schizophrenia. Reportedly, Fanapt belongs to a class of medication for schizophrenia known as atypical antipsychotics. Novartis plans to launch Fanapt in the US in early 2010.

As part of the agreement with Vanda Pharmaceuticals (Vanda), Novartis will have exclusive commercialisation rights to the oral formulation of this medicine in the US and Canada for which it has to pay $200 million. Further it will have exclusive rights to develop and commercialise a long-acting injectable (depot) formulation of this medicine for these markets.

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. Vanda completed Phase III clinical trials in 2006 and gained US regulatory approval for this medicine in May 2009.

Ludwig Hantson, head of Pharma North America, CEO, Novartis, said: "Schizophrenia remains one of the most chronic and debilitating of the major psychiatric illnesses, underscoring the need for new treatment options. With the launch of Fanapt in early 2010, we will broaden our presence in psychiatry and build on the heritage of Novartis in offering innovative treatments for devastating psychiatric diseases."

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