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news.Azur Pharma, a developer of specialist therapeutic products, has entered into an agreement with Elan, a neuroscience-based biotechnology company, to develop and commercialize once-daily formulations of clozapine using Elan's proprietary drug delivery technologies, including its NanoCrystal technology.
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Under the terms of the agreement, Azur will be responsible for the clinical development program, the regulatory approval process, and the commercialization of the product in the US, with an option to expand its rights to countries outside the US.
Elan will develop the formulation and manufacture the product. Elan will receive payments upon the achievement of development, clinical, and regulatory milestones, and manufacturing fees and royalties on sales of the product.
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.
Shane Cooke, CFO and head of Elan Drug Technologies, said: “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.”