GAITHERSBURG, MD and SHANGHAI, China
MedImmune, the global biologics arm of AstraZeneca, and WuXi AppTec, a leading research and development outsourcing company, today announced that they 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.
“We are pleased to partner with WuXi AppTec, a company with strong leadership in the Chinese pharmaceutical R&D sector, to help us address the healthcare needs of Chinese patients through the co-development of MEDI5117,” said Bahija Jallal, Executive Vice President, Research & Development, MedImmune. “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.”
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.
“WuXi is delighted to work with MedImmune, an innovative biologics company, to develop and manufacture a novel product for first use in China,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “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.”
Today’s announcement supports AstraZeneca’s ongoing commitment to collaborating across Asia in ways that maximize the scientific and local knowledge of its partners and tap into the region’s strong history of innovation.
The Chinese government’s focus on healthcare reform, along with its investment in improving healthcare infrastructure and expanding medical insurance coverage, are expected to continue to drive growth and demand for quality medicines over the long term. China also continues to increase its biomedical R&D investment, fuelled by sustained GDP growth. The Chinese pharmaceutical market grew from $10 billion in 2004 to $41 billion in 2010 and, according to IMS Health, is projected to grow to over $100 billion by 2014.
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. 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.
Cautionary Note Regarding Forward-Looking Statements for WuXi PharmaTech
Statements in this release contain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the Private Securities Litigation Reform Act of 1995, including, among others, the development and commercialization of MEDI5117; the anticipated benefits of the joint venture to the parties; the ability of the joint venture to accelerate the development of novel medicines for the Chinese market; the Chinese government’s focus on healthcare reform and improving healthcare infrastructure; the expansion of medical insurance coverage in China; the expected growth in demand for quality medicines; and the projected growth of the Chinese pharmaceutical market.
These forward-looking statements are not historical facts but instead represent only our belief regarding future events, many of which, by their nature, are inherently uncertain and outside of our control. WuXi PharmaTech’s, including WuXi’s and the joint venture’s, actual results and financial condition and other circumstances may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Among other factors, the parties may not realize the anticipated benefits of the joint venture; the joint venture may experience operational difficulties or management distraction; and MedImmune’s and WuXi’s interests may not be fully aligned initially or may diverge in the future. Further, the state of the global economy may continue to be uncertain; WuXi may fail to capitalize on the opportunities presented; the pressures being felt by WuXi’s customers and pharmaceutical industry consolidation may adversely impact its business and the trends for outsourced and offshored R&D and manufacturing for longer than expected or more severely than expected; WuXi may not enjoy the anticipated benefits of the Abgent and MedKey acquisitions or other planned investments and capital expenditures (including investments made through our corporate venture fund) on a timely basis or at all; WuXi may need to modify the nature and level of its investments and capital expenditures; WuXi may not maintain its preferred provider status with its clients and may be unable to successfully expand its capabilities to meet client needs; WuXi may face increased margin pressure as a result of renminbi appreciation and increased labor inflation in China and the company’s investments; and WuXi may not repurchase its ADSs as anticipated for market or other reasons. In addition, other factors that could cause WuXi ‘s actual results to differ from what it currently anticipates include failure to generate sufficient future cash flows or to secure any required future financing on acceptable terms or at all; failure to retain key personnel; WuXi’s reliance on a limited number of customers to continue to account for a high percentage of its revenues; the risk of payment failure by any of its large customers, which could significantly harm its cash flows and profitability; WuXi ‘s dependence upon the continued service of our senior management and key scientific personnel, and WuXi ‘s ability to retain its existing customers or expand its customer base. You should read the financial information contained in this release in conjunction with the consolidated financial statements and related notes thereto included in WuXi‘s 2011 Annual Report on Form 20-F filed with the Securities and Exchange Commission and available on the Securities and Exchange Commission’s website at http://www.sec.gov. For additional information on these and other important factors that could adversely affect WuXi‘s business, financial condition, results of operations and prospects, see “Risk Factors” beginning on page 6 of WuXi‘s 2011 Annual Report on Form 20-F. WuXi‘s results of operations for second-quarter 2012 are not necessarily indicative of our operating results for any future periods. All projections in this release are based on limited information currently available to WuXi, which is subject to change. Although these projections and the factors influencing them will likely change, WuXi undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release, except as required by law. Such information speaks only as of the date of this release.
MedImmune, the global biologics arm of AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com.
About WuXi AppTec
WuXi AppTec is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi AppTec’s services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXi AppTec is the name for the operating subsidiaries of WuXi PharmaTech. For more information, please visit: http://www.wuxiapptec.com.