In November 2008, Azur Pharma Limited and Elan Corporation plc (both of Dublin, Ireland) agreed to develop and commercialize once-daily formulations of clozapine using Elan’s proprietary drug delivery technologies, including its NanoCrystal technology.

Clozapine is currently marketed in immediate release presentations, including Azur's proprietary orally-disintegrating tablet brand, FazaClo. Clozapine is indicated for the management of severely-ill schizophrenic patients who fail to respond adequately to standard drug treatments for schizophrenia, 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.

As described in an Elan company statement, "NanoCrystal technology involves manipulating the particle size of the drug at the nano-scale—somewhere between the width of a DNA strand and an atom. By reducing particle size to the nanometer scale, the exposed surface area of the drug is increased, and thus improving its ability to be absorbed. Applicable to poorly water-soluble compounds, the drug in nano-form can be incorporated into common oral, injectable, and inhaleable dosage forms."

"This agreement continues to validate the robustness and flexibility of our technology platform. We look forward to progressing our work with Azur and assisting them in their efforts to bring a once-daily clozapine to the market," says Shane Cooke, executive vice president, chief financial officer and head of Elan Drug Technologies.

This article was published in Drug Discovery & Development magazine: Vol. 12, No. 1, January, 2009, pp. 10.