Organon achieves milestone in Asenapine development collaboration
Organon announced the achievement of a development milestone for asenapine, a novel psychotherapeutic investigational drug for the treatment of psychotic and mood disorders, which will result in a retroactive change in the division of full phase III development costs, with Pfizer increasing its share. The agreed future revenue sharing will remain in place. The milestone relates to satisfactory results in the companies' clinical trial program.
The achievement of the milestone, of which no further specifics were disclosed, reconfirms the commitment of both companies to fully explore the clinical potential.
Asenapine is a novel psychotherapeutic investigational drug being developed for the treatment of psychotic and mood disorders. It has a unique neuropharmacological receptor signature that distinguishes it from current antipsychotics, antidepressants and mood stabilizers. Early clinical results indicate that asenapine will restore balance to a patient's life through superior relief of negative symptoms and strong control of positive symptoms in schizophrenia. Reduction of manic symptoms in bipolar disorder are also being evaluated. Current knowledge suggests asenapine to have an excellent safety profile and to be well tolerated. The phase III clinical development program is expected to be finalized by the end of 2006, with an NDA submission foreseen early 2007.
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