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December 22, 2008
By: Tim Wright
Editor-in-Chief, Contract Pharma
AstraZeneca and MAP Pharmaceuticals have formed an exclusive worldwide agreement to develop and commercialize Unit Dose Budesonide (UDB), MAP Pharmaceuticals’ proprietary nebulized formulation of budesonide. UDB is being developed by MAP Pharmaceuticals as a potential treatment for pediatric asthma and is currently in Phase III. UDB has the potential to be nebulized more quickly and at a lower nominal dose than the commercially available product. AZ will pay MAP an upfront cash payment of $40 million and an additional $35 million upon the successful achievement of primary endpoint and safety results in the currently ongoing Phase III study. MAP is also eligible to receive as much as $240 million in other potential development and regulatory milestones, as well as additional progressively demanding sales performance-related milestone payments of as much as $585 million in the event the product is a “considerable commercial success,” according to an AZ statement. MAP and AZ will develop UDB in the U.S. and AZ has rights to develop and commercialize UDB outside of the U.S. MAP is eligible to receive significant double-digit royalty payments on net sales of UDB worldwide, and AZ will support and fund the establishment of a MAP sales force to co-promote UDB in the U.S. for a certain period of time after product launch. AZ will be responsible for future UDB development costs and will reimburse MAP for the costs of future UDB development activities with respect to U.S. registration. David Brennan, AZ’s chief executive officer, remarked, “MAP Pharmaceuticals’ advancement in UDB represents an important potential new option for treating children confronting asthma. AstraZeneca’s heritage in treating pediatric asthma, combined with MAP’s expertise can open new areas of opportunity for both companies and has the potential to bring significant medical benefit to the wider community.” UDB is being developed utilising a license to Elan’s proprietary NanoCrystal Technology. The small size and stability of NanoCrystal drug particles are designed to enable improved delivery efficiency of drug formulations to the lung via nebulization, according to AZ.
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