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Azur Pharma and Elan Corporation (NYSE: ELN) Sign Agreement to Develop a Once-Daily Clozapine

DUBLIN, November 10 /PRNewswire/ -- Azur Pharma Limited ("Azur") today announced that it has entered into an agreement to develop and commercialise once-daily formulations of clozapine using Elan Corporation plc's ("Elan")(NYSE:ELN) proprietary drug delivery technologies, including its NanoCrystal(r) technology.

Clozapine is currently marketed in immediate release presentations, including Azur's proprietary orally disintegrating tablet brand, FazaClo(r). 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 behaviour 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 programme.

Seamus Mulligan, Chairman and Chief Executive of Azur, commented, "We are pleased to collaborate with Elan to apply their unique patented drug delivery technologies to this important drug. We have already made significant progress under our preliminary agreement. This represents a very significant commercial opportunity that will leverage Azur's existing infrastructure and knowledge of the clozapine market, and build on Azur's other FazaClo line extension programmes."

Under the terms of the agreement, Azur will be responsible for the clinical development programme, the regulatory approval process, and the commercialisation 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.

"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," commented Shane Cooke, Executive Vice President, Chief Financial Officer and Head of Elan Drug Technologies.

About Azur Pharma Azur is a privately held pharmaceutical company dedicated to enhancing patients' lives by developing and marketing pharmaceutical products in specialist therapeutic areas. Azur's strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development and approved pharmaceutical products. (Website:

NanoCrystal(r) Technology is a registered trademark of Elan Pharma International Limited, Ireland. For more information on Elan's drug delivery technologies including the NanoCrystal(r) Technology, please visit

SOURCE Azur Pharma Limited
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