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AstraZeneca forges CRO alliance to bring biologic to China

MedImmune Subsidiary forms joint venture with WuXi

AstraZeneca's MedImmune subsidiary has formed a joint venture with contract research organisation (CRO) WuXi AppTec to bring inflammatory disease candidate MEDI5117 to the Chinese market.

MedImmune will contribute its technical and development expertise to the 50:50 partnership, while WuXi will provide local regulatory, manufacturing, pre-clinical and clinical trial support.

MEDI5117 is a fully human interleukin-6 (IL-6) targeting monoclonal antibody that was developed using MedImmune's YTE technology, which has extended the antibody's half-life and clearance in the body.

The mAb is currently in phase I studies in the US and Europe, and has potential in a broad range of inflammatory and autoimmune diseases, notably rheumatoid arthritis. As yet an application to start clinical trials in China has not been filed.

The deal is slightly different from the typical pharma/CRO relationship in that the joint venture will control the development of MEDI5117 in China, and the two companies will have equal ownership in the project. WuXi - which is China's largest national CRO - will earn fee-for-service revenues from the agreement.

Medimmune retains an option to gain full control of MEDI5117 at the point of commercialisation, and is eligible for milestone payments as the programme progresses.

"This strategic partnership will enable us to establish a leadership presence in developing novel biologics in China, complementing AZ's investment in this important emerging market," said Medimmune's executive vice president for R&D Bahija Jallal.

In an interview with Reuters, Jallal said tapping into WuXi's local expertise would carve six years off the time to get MEDI5117 onto the market in China. Traditionally, foreign pharma companies have had to apply for an import license in China after securing approval in other markets.

"WuXi is working to build long-term drug development partnerships with leading biopharmaceutical companies like MedImmune to help accelerate the development of novel medicines for the large and rapidly growing Chinese pharmaceutical market," commented Ge Li, the CRO's chairman and chief executive.

11th September 2012

From: Research, Sales

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