Key Developments For Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. (VNDA.O) (Consolidated Issue listed on NASDAQ Global Market)
Vanda Pharmaceuticals Inc. Enters Into Exclusive License Agreement With Novartis AG's Novartis Pharma AG For Commercialization And Development Of Fanapt In U.S. And Canada
Vanda Pharmaceuticals Inc. announced that it has entered into an agreement with Novartis AG's Novartis Pharma AG to commercialize and develop Fanapt, Vanda's anti-psychotic, in the U.S. and Canada. Fanapt is a mixed dopamine D2 / serotonin 5HT2A receptor antagonist. The U.S. anti-psychotic market is approximately $14 billion. Under the terms of the agreement, which amended and restated a prior agreement among the parties, Novartis will have exclusive commercialization rights to Fanapt for the U.S. and Canada. Novartis will be responsible for the further clinical development activities in these territories, including the development and commercialization of a long-acting injectable formulation of Fanapt. Vanda will retain rights to commercialize Fanapt oral and depot formulations outside the U.S. and Canada. At Novartis' option, the parties will enter into good faith discussions relating to an agreement for the co-commercialization of Fanapt outside of the U.S. and Canada or, alternatively, Novartis will receive a royalty on net sales. Under the agreement, Vanda will receive an upfront payment of $200 million and will be eligible for additional payments totaling up to $265 million upon the achievement of certain development and commercial milestones for Fanapt in the U.S. and Canada. Vanda will also receive royalties on the U.S. and Canadian net sales of Fanapt. The consummation of the transaction is expected by the end of 2009.
FDA Approves Vanda Pharmaceuticals Inc.'s Fanapt For Treatment Of Schizophrenia
Vanda Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) has granted marketing approval of Fanapt (iloperidone) for the acute treatment of adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase III clinical studies comparing Fanapt to placebo and active control in patients with schizophrenia, as well as safety data from more than 3,000 patients. Fanapt is a mixed dopamine D2 / serotonin 5HT2A receptor antagonist, and belongs to the class of atypical antipsychotics. The efficacy of Fanapt for the treatment of schizophrenia was supported by two placebo-controlled short-term (four and six week) trials. Both trials enrolled patients who met the DSM-III/IV criteria for schizophrenia, and Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia across doses of 12mg to 24mg per day. The recommended target dose range of Fanapt is 12mg to 24 mg per day. Titration to the target dose of 12mg per day can be achieved in 4 days. The Company plans to make Fanapt available in pharmacies later this year.
Vanda Pharmaceuticals Inc. Reports New Insights into the Mechanism of Action of Antipsychotic Drugs
Vanda Pharmaceuticals Inc. announced the publication in Schizophrenia Research, the official journal of the Schizophrenia International Research Society, of a manuscript entitled 'Common effect of antipsychotics on the biosynthesis and regulation of fatty acids and cholesterol supports a key role of lipid homeostasis in schizophrenia'. This publication highlights the discovery of a major effect of antipsychotics that sheds new light on how these drugs work. Vanda researchers analyzed the mechanism of action of 18 antipsychotics at the molecular level and discovered that they regulate specific genes that control the production and transport of lipids. These findings suggest that antipsychotic drugs may alter the fluidity of cell membranes of neurons, which could result in changes in neuronal connectivity. The antipsychotics tested included Vanda's antipsychotic iloperidone, currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia.
Vanda Pharmaceuticals Inc. Announces Resignation Of Steven A. Shallcross As Chief Financial Officer-Form 8-K
Vanda Pharmaceuticals Inc. announced in its Form 8-K that Steven A. Shallcross, Senior Vice President, Chief Financial Officer and Treasurer has been terminated as resulted in a workforce reduction.
FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission And Sets New Action Date
Vanda Pharmaceuticals Inc. announced that the FDA has accepted Vanda's resubmission of the iloperidone New Drug Application (NDA). Vanda's resubmission was a Complete Response to the not approvable action letter that the Company received on July 25, 2008. The FDA has indicated that it has accepted the Complete Response for review and has set a new target action date of May 6, 2009.
