Dov Pharmaceutical Inc has received confirmation from Neurocrine Biosciences Inc and Wyeth that the United States composition of matter patent for indiplon (no. 6,399,621) issued to a former Wyeth subsidiary (American Cyanamid) in June 2002 falls under the license agreement to Dov from American Cyanamid, and the sublicense agreement to Neurocrine from Dov. Dr. Bernard Beer, President of Dov, is the senior inventor on the new patent. With this new patent, the Dov/Neurocrine sublicense agreement and its underlying royalty payments extend until at least 2020.
In addition, in November 2002 Neurocrine announced positive results from its first phase III clinical trial with indiplon-IR capsules, achieving both primary and secondary endpoints of sleep initiation. Neurocrine further reported: With this trial, indiplon has been studied in approximately 2000 subjects and patients and the results have been consistently positive.
In addition to this Phase III study, Neurocrine is currently conducting four additional Phase III clinical trials with indiplon-IR and three Phase III clinical trials with indiplon-MR. Neurocrine has initiated and is completing all of its multiple Phase III safety and efficacy trials to support a New Drug Application (NDA) registration with the Food and Drug Administration. The NDA will include two formulations of indiplon: indiplon-IR capsules and indiplon-MR tablets for multiple indications associated with insomnia.