Monday, April 11, 2011

FDA approves Invega "paliperidone! for children while Vanda Pharmaceutical: clinical trial for Fanapt "iloperidone"

Yes. Invega for children 12-17 years old:
TITUSVILLE, N.J.April 11, 2011 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) on April 6 approved INVEGA® (paliperidone) extended-release tablets for the treatment of schizophrenia in adolescents 12 to 17 years of age. The efficacy of INVEGA® to treat schizophrenia in adolescents was established in one six-week clinical study. INVEGA® is an atypical antipsychotic medication and was first approved in the U.S. in December 2006 for the treatment of schizophrenia in adults. Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., markets INVEGA® in the U.S.

whole article here.
Vanda Pharmaceutical wants all the money from Fanapt

Rockville-based biopharmaceutical company Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) has announced that Novartis Pharmaceuticals Corp., an affiliate of Vanda's sub-licensor Novartis Pharma AG, has initiated a clinical study to evaluate the long-acting injectable formulation of Fanapt (iloperidone).
The Phase 1 study will evaluate the safety and pharmacokinetic profiles of two different long-acting formulations in patients with schizophrenia. Vanda Pharmaceuticals is focused on the development and commercialization of clinical-stage products for central nervous system disorders.
Vanda Pharmaceuticals said that under a 2009 agreement, Novartis has exclusive rights to the depot formulation of Fanapt in the U.S. and Canada. Vanda has exclusive rights to the depot formulation outside the U.S. and Canada, but Switzerland-based Novartis has the option to enter into discussions with Vanda to co-commercialize Fanapt or receive sales royalties for such territory. (emphasis mine, the lunatic)
Schizophrenia is a chronic, severe and disabling mental disorder, characterized by profound disruptions in thinking, affecting language, perception and the sense of self. It often includes psychotic experiences, such as hearing voices or delusions. Schizophrenia typically begins in late adolescence or early adulthood and affects 2.4 million Americans, or 1.1 percent of the U.S. adult population.

After all these good news we can be at peace.

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