Neurocrine Biosciences Inc announced the issuance of U.S. Patent No. 6,544,999 (the '999 patent) covering a stable polymorph of its proprietary compound indiplon for the treatment of insomnia. The '999 patent will provide Neurocrine with patent protection for this important crystalline form of indiplon until the year 2020.
"This new patent complements the patent portfolio which we are developing around this important product for the treatment of insomnia. We have previously received patents covering different synthetic schemes for the synthesis of indiplon, the modified release formulation of indiplon, and methods of making and converting polymorphs of indiplon. We had previously announced the issuance of U.S. Patent No. 6,399,621 which covers indiplon and the use of indiplon for the treatment of sleep disorders last summer," said Margaret Valeur-Jensen, Senior Vice President, General Counsel and Corporate Secretary of Neurocrine Biosciences. "The '999 patent is the latest to issue from our indiplon portfolio and we expect the issuance of our other patent applications which will further expand and extend worldwide protection for this compound."
Neurocrine recently entered into a global agreement with Pfizer Inc for the exclusive worldwide development and commercialization of indiplon. Pfizer will also fund the ongoing development of indiplon and pay royalties on worldwide sales and co-promotion fees in the United States. The companies will develop and co-promote indiplon in the United States with Pfizer holding an exclusive license to develop and market indiplon outside the United States. Additionally, Pfizer will support the creation of a 200-member Neurocrine sales force to reach psychiatrists and sleep specialists. Neurocrine will detail Zoloft to U.S. psychiatrists after submission of the indiplon New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) expected in early 2004.
Indiplon is a unique non-benzodiazepine that acts on a specific site of the GABA-A receptor. It is through this mechanism that the currently marketed non-benzodiazepine therapeutics also produce their sleep-promoting effects. However, indiplon is more potent than the currently marketed non- benzodiazepines at the specific subtype of receptors within the brain believed to be responsible for promoting sleep.
Insomnia is a prevalent neurological disorder in the United States, with more than one-half of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundation's (NSF) Sleep in America Poll 2002. Approximately 35% of the adult population reports that they experience insomnia every night or almost every night. Despite this widespread prevalence, insomnia remains a disorder with high unmet medical needs.