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Agreement

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Date: 2010-09-09
Biotech partner: Shire Pharmaceuticals (UK) Acceleron Pharma (USA)
Type of agreement: * R&D
* licensing
* commercialization/ distribution
* development
Compound: activin receptor type IIB (ActRIIB) class of molecules including ACE-031
Disease area: Duchenne Muscular Dystrophy
Development phase: ACE-031 is currently in Phase 2a
Nature of the agreement: Shire plc is expanding its Human Genetic Therapies pipeline through the exclusive license, in markets outside of North America, for the activin receptor type IIB (ActRIIB) class of molecules being developed by Acceleron Pharma.
The collaboration will initially investigate ACE-031, Acceleron’s lead ActRIIB drug candidate, currently in a Phase 2a trial for the treatment of patients with Duchenne Muscular Dystrophy.
Shire and Acceleron will jointly collaborate on a worldwide development program to advance ACE-031 into a global Phase 2/3 clinical program designed to demonstrate disease modification in DMD patients. Shire will utilize its Lexington, Massachusetts manufacturing facility to produce commercial supplies of the product for both parties. If marketing authorization is received, Acceleron will commercialize ACE-031 in the U.S. and Canada, and Shire has the exclusive right to commercialize the therapy in the rest of the world.
Financial terms of the agreement: Under the terms of the agreement, Shire will make an upfront payment to Acceleron of $45 million. Acceleron is eligible to receive additional development, regulatory and sales milestone payments of up to $165 million for the successful commercialization of ACE-031 in DMD, up to an additional $288 million for successful commercialization of other indications and molecules, and royalties on product sales. Shire will also make a contribution to global development costs.


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