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Novartis Pharma AG 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. Novartis plans to launch Fanapt in the US in early 2010.
As part of the agreement with Vanda Pharmaceuticals Inc, Novartis will have exclusive commercialisation rights to the oral formulation of this medicine in the US and Canada as well as exclusive rights to develop and commercialise a long-acting injectable (or “depot”) formulation of this medicine for these markets.
Schizophrenia is a severe psychiatric disorder that is estimated to affect more than 2 million adults in the US and nearly 250,000 Canadians. Fanapt belongs to a class of medication for schizophrenia known as atypical antipsychotics.
“Schizophrenia remains one of the most chronic and debilitating of the major psychiatric illnesses, underscoring the need for new treatment options,” said Ludwig Hantson, Head of Pharma North America, CEO, Novartis Pharmaceuticals Corporation.
“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.”
Novartis was a pioneer in offering Clozaril (clozapine) as the first atypical antipsychotic medication in the 1970s, which was considered a breakthrough for patients with treatment-resistant schizophrenia. Novartis also offers medications for Alzheimer’s disease, attention deficit hyperactivity disorder (ADHD), Parkinson’s disease and multiple sclerosis.
Vanda completed phase III clinical trials in 2006 and gained US regulatory approval for this medicine in May 2009.