A venture in the East

GAITHERSBURG, Md.—Early September saw the launch of a jointventure between MedImmune, the global biologics arm of AstraZeneca PLC, andresearch and development outsourcing company WuXi AppTec. The joint venture'smain focus will be the development and commercialization in China of MEDI5117,a novel biologic for autoimmune and inflammatory diseases.

"WuXi is delighted to work with MedImmune, an innovativebiologics company, to develop and manufacture a novel product for first use inChina," Dr. Ge Li, chairman and CEO of WuXi AppTec, said in a press release."WuXi is working to build long-term drug development partnerships with leadingbiopharmaceutical companies like MedImmune to help accelerate the developmentof novel medicines for the large and rapidly growing Chinese pharmaceuticalmarket."

MedImmune will provide its technical and developmentexpertise to the undertaking, while WuXi AppTec will be responsible forproviding local regulatory, manufacturing, preclinical and clinical trialsupport. The two companies will split the investment in the joint venture andwill have equal ownership. The joint venture will have the right tocommercialize MEDI5117, though AstraZeneca/MedImmune will have the option toacquire full rights to commercialization. WuXi AppTec will receive revenuebased on services rendered, and MedImmune will be eligible for variousmilestone payments. Specific financial details were not disclosed.

"Wuxi AppTec is a well-known and highly regarded Chinesepharmaceutical services provider, and has research and manufacturingpartnerships with many major global pharmaceutical companies," says TracyRossin, director of corporate public relations for MedImmune. "We have beenimpressed with Wuxi AppTec's ability to execute on its business operationsto-date and look forward to working together to address the healthcare needs ofChinese patients through the codevelopment of potential novel medicines such asMEDI5117."

According to a company spokesperson at WuXi AppTec, thecompanies have worked together before, and discussions regarding this venturehave been ongoing between the companies throughout the year. The spokespersonsays WuXi AppTec is "impressed with MedImmune's world-class capabilities inbiologics and with the risk/reward profile and commercial potential ofMEDI5117."

MEDI5117 is a novel investigational biologic that includesMedImmune's proprietary YTE technology. YTE refers to three mutations thatincrease antibody immunoglobulin binding and result in a longer circulatinghalf-life for an antibody, and the addition of these mutations can bolster thebinding properties of a therapy to lead to antibody therapies with half-livesthree or four times longer than other currently available therapies. MEDI5117is a fully human monoclonal antibody that depletes IL-6, an important mediatorin the production of inflammation and pain, and is being studied in autoimmuneand inflammatory diseases such as rheumatoid arthritis. A local investigationalnew drug application will be filed for the compound in China, after which PhaseI trials will begin.

"MedImmune's biopharmaceutical development team will workclosely with WuXi AppTec to ensure successful manufacturing, processdevelopment and quality control. In addition, MedImmune's clinicians, given theirextensive experience in clinical trial design and execution, will work closelywith WuXi AppTec's team to meet the Chinese regulatory requirements," saysRossin.

Though MEDI5117 will be the focus of the joint venture, bothcompanies say they are optimistic the arrangement could expand to includeadditional opportunities in the future.

"MedImmune's joint venture with WuXi AppTec complementsAstraZeneca's strategy in China, and its ongoing commitment to collaboratingacross Asia in ways that maximize the scientific and local knowledge of itspartners and tap into the region's strong history of innovation," Rossin adds.

The Chinese pharmaceutical market continues to drawsignificant attention lately, thanks to its rapid growth. The market grew from$10 billion in 2004 to $41 billion in 2010, and according to IMS Health, it isexpected to grow to more than $100 billion by 2014.