Date: 2012-09-10
Type of information: Joint-venture agreement
Compound: MEDI5117
Company: MedImmune (USA), the global biologics arm of AstraZeneca (UK), WuXi AppTec (China)
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Immunological diseases
Type agreement: joint venture
development
commercialisation
Action mechanism: MEDI5117 is currently being studied in autoimmune and inflammatory diseases such as rheumatoid arthritis. MEDI5117, a novel investigational biologic, is a fully human monoclonal antibody that depletes IL-6 and bears MedImmune’s proprietary half-life extending mutation (known as the “YTE” technology) designed to give a long duration of action. IL-6 is known to be an important mediator in the production of inflammation and pain in a variety of disease states.
Disease: autoimmune diseases, inflammatory diseases
Details: MedImmune, the global biologics arm of AstraZeneca, and WuXi AppTec, a leading research and development outsourcing company, have formed a joint venture to develop and commercialize MEDI5117, a novel biologic for autoimmune and inflammatory diseases, in China.MedImmune will provide technical and development expertise, while WuXi AppTec will provide local regulatory, manufacturing, pre-clinical and clinical trial support. When undertaking clinical trial development in China, the government requires local manufacture of medicines that have not been approved in other markets. MEDI5117 is currently in phase I in the US and Europe. In China, a local investigational new drug (IND) application will be filed for MEDI5117. Following that process, phase I trials will be initiated.
The joint venture will control the development of MEDI5117 for autoimmune and inflammatory diseases in China, and the two companies will have equal ownership in the joint venture. AstraZeneca / MedImmune will have the option to acquire the full rights to commercialize MEDI5117; otherwise, the joint venture will have the right to commercialize the product. WuXi AppTec will earn revenue based on services provided to the joint venture. MedImmune will receive various milestone payments as the program progresses.
Financial terms:
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