Azur and Elan to co-develop once-daily clozapine

Azur Pharma has entered into an agreement to develop and commercialize once-daily formulations of clozapine using fellow Ireland-headquartered Elan Corp's proprietary drug delivery technologies, including NanoCrystal.

Clozapine is currently marketed in immediate-release presentations, including Azur's proprietary, orally-disintegrating tablet brand, FazaClo. The drug is indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatments or the condition, and for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorders. Formulation development activities have been underway since 2007 under a preliminary agreement with Elan, and the companies have now elected to progress to a full development program.

Under the terms of the deal, Azur will be responsible for the clinical development program, regulatory approval process, and commercialization of the product in the USA, with an option to expand its rights to countries outside that country. Elan will develop the formulation and manufacture the product and will receive payments on the achievement of development, clinical, and regulatory milestones, as well as manufacturing fees and royalties on sales of the product.