Novartis Launches Fanapt In US

Fanapt belongs to a class of medications for schizophrenia known as atypical antipsychotics. The FDA approval of Fanapt was supported by two placebo-and active-controlled short-term trials and safety data derived from more than 2,000 patients. Both trials enrolled patients who met the DSM-III/IV criteria for schizophrenia.

In the study, Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia across doses of 12mg to 24mg per day, which is the recommended daily target dose range. Titration to the target dose of 12mg per day can be achieved in four days, said the company.

Reportedly, in October 2009, Vanda Pharmaceuticals (Vanda) and Novartis have entered into an agreement, pursuant to which Novartis has exclusive US and Canadian commercialisation rights to Fanapt.

As per the agreement, Vanda has received an upfront payment of $200m and is eligible for future payments totaling up to $265m upon the achievement of certain commercial and development milestones for Fanapt, as well as royalties based upon net sales.

Novartis assumed the commercialisation and further clinical development activities in the US and Canada, including the development and commercialisation of a long-acting injectable (or depot) formulation of Fanapt.

Vanda retains the right to commercialise Fanapt oral and depot formulations outside the US and Canada. At Novartis’ option, the parties will enter into good faith discussions relating to an agreement for the co-commercialisation of Fanapt outside of the US and Canada or, alternatively, Novartis will receive a royalty based upon net sales.