MedImmune signs China deal
pharmafile | September 11, 2012 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | AstraZeneca, China, MedImmune, WuXi, emerging markets, rheumatoid arthritis
MedImmune has sealed a joint venture with Shanghai-based WuXi AppTec to develop a novel biologic for autoimmune and inflammatory diseases for the Chinese market.
MEDI5117 is currently in Phase I in Europe and the US for conditions such as rheumatoid arthritis and the plan is to make an investigational new drug application in China and begin Phase I trials there too.
MedImmune has signed the deal with the Chinese CRO and drug development firm because of the regulatory and logistical demands of conducting clinical trials in China.
MedImmune, the biologics arm of AstraZeneca, will be in charge of developing the drug in China while WuXi is to give local regulatory, manufacturing, pre-clinical and clinical trial support.
The companies will have equal ownership in the joint venture, with AstraZeneca/MedImmune given the option to acquire full rights to commercialise MEDI5117.
WuXi AppTec will be paid according to the services it provides to the project while MedImmune is in line to receive various milestone payments.
The drug is a fully human monoclonal antibody which depletes IL-6, a key element in producing inflammation and pain in a variety of diseases. The molecule carries MedImmune’s proprietary adaptation – ‘YTE’ technology – which is designed to extend the time it is active.
This is a key therapy area for AstraZeneca: in May, it bought its way into Amgen’s inflammation portfolio with a $50 million upfront payment to co-develop and commercialise five monoclonal antibodies.
China also represents a vital geographical area, of course: AstraZeneca is the largest multinational pharma company in China’s prescription market and has more than 4,700 employees there covering in manufacturing, sales, clinical research, and new product development.
The Chinese pharma market grew from $10 billion in 2004 to $41 billion in 2010 and, according to IMS Health, will reach more than $100 billion in the next two years.
AstraZeneca was quick to spot these possibilities: in May 2006 it announced a $100 million R&D investment, which included the establishment of the AstraZeneca Innovation Centre China in Shanghai.
Such experience may be crucial for the new deal: any medicines used in clinical trials in China that have not been approved in other markets must be manufactured locally by law.
“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,” said Bahija Jallal, MedImmune’s executive vice president, R&D.
“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,” said WuXi chairman Ge Li.
Adam Hill
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