AstraZeneca and MAP Pharmaceuticals, Inc. announced 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 clinical development. UDB has the potential to be nebulized at a lower nominal dose than the commercially available product.
Under the terms of the agreement, AstraZeneca will pay MAP Pharmaceuticals 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 clinical study.
In addition, upon the occurrence of certain events and conditions, MAP Pharmaceuticals is eligible to receive up to $240 million in other potential development and regulatory milestones.
The agreement also provides for additional progressively demanding sales performance-related milestone payments of up to $585 million in the event the product is a considerable commercial success.
This agreement is subject to review by the United States Government under the Hart-Scott-Rodino Act and becomes effective after the expiration or earlier termination of the waiting period (or any extension thereof).
AstraZeneca also will support and fund the establishment of a MAP Pharmaceuticals sales force to co-promote UDB in the United States for a certain period of time after product launch. MAP Pharmaceuticals is also eligible to receive significant double-digit royalty payments on net sales of UDB worldwide.
MAP Pharmaceuticals and AstraZeneca will develop UDB in the United States and AstraZeneca has rights to develop and commercialize UDB outside of the United States. Under the agreement, AstraZeneca will be responsible for future UDB development costs and AstraZeneca will reimburse MAP Pharmaceuticals for the costs of future UDB development activities with respect to United States registration incurred by MAP Pharmaceuticals.
David Brennan, Chief Executive Officer of AstraZeneca said, "MAP Pharmaceuticals' advancement in Unit Dose Budesonide represents an important potential new option for treating children confronting asthma. AstraZeneca's heritage in treating pediatric asthma, combined with MAP Pharmaceuticals' 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 utilizing 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.