Recently, Novartis (NVS) launched Fanapt (iloperidone) in the U.S. Its twice daily tablets are for the treatment of schizophrenia in adults. Fanapt received approval from the US Food and Drug Administration (FDA) in May 2009.
Clinical trials have shown that Fanapt improved symptoms in schizophrenic patients compared to a placebo therapy. The most common adverse drug reactions were dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia and weight gain.
Under an agreement with Vanda Pharmaceuticals (VNDA), Novartis acquired exclusive commercialization rights to Fanapt in the U.S. and Canada in October 2009. In addition, Novartis has the rights to develop and commercialize an injectable form of the drug for these markets. Vanda will receive an upfront payment of $200 million as well as the potential to receive milestone payments of up to $265 million. Vanda also will receive royalties on the US and Canadian net sales of Fanapt.
In December 2009, Eli Lilly (LLY) received FDA approval for Zyprexa Relprevv (olanzapine), the new extended-release injectable version of its blockbuster drug Zyprexa for the treatment of schizophrenia in adults. With respect to treatment option, the approval is significant as the Zyprexa Relprevv injection maintains therapeutic drug levels for up to four weeks, when the disease relapses following irregular intake of prescribed medications. Long-acting treatments play a beneficial role since non-adherence to medication is a big problem for the patients.
Schizophrenia is a chronic, severe and disabling mental disorder affecting 2.4 million Americans or about 1.1% of the adult population in the U.S. While there is no cure for the disease, proper medication can keep it in check. As per estimates, the global schizophrenia market was valued at $15.9 billion in 2008 which is expected to reach $17.2 billion by 2015.
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