MedImmune, the global biologics arm of AstraZeneca, and WuXi AppTec, an R&D 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 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 designed to give a long duration of action.
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.
Bahija Jallal, executive vice president, R&D, MedImmune, said, "This strategic partnership will enable us to establish a leadership presence in developing novel biologics in China, complementing AstraZeneca's investment in this important emerging market."
MEDI5117 is currently in phase I in the U.S. 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.