ROCKVILLE, Md. and SHANGHAI, China, June 11, 2015 -- REGENXBIO Inc., a leading biotechnology company in gene therapy, today announced that it has entered into an exclusive strategic manufacturing collaboration with WuXi AppTec, Inc (WuXi). WuXi is a leading technology platform company that provides clients with a broad and integrated portfolio of laboratory and manufacturing services, including expertise in characterization and analysis of biologics. Through this collaboration, REGENXBIO plans to establish efficient, scalable manufacturing processes within current Good Manufacturing Practice (cGMP) guidelines for the production of adeno-associated virus (AAV) gene therapy treatments incorporating REGENXBIO's NAV® Technology.
Under the terms of the agreement, REGENXBIO and WuXi will establish a proprietary production process for NAV Technology treatments designed to enable the rapid advancement of REGENXBIO's and licensees' therapeutic programs from clinical trials through commercialization in WuXi's 145,000 square-foot cGMP facility currently under construction in Philadelphia. This facility is specially designed to accommodate gene therapy products that contain viral vectors such as REGENXBIO's NAV Technology platform. The partnership will combine REGENXBIO's expertise in AAV process development with WuXi's commercial manufacturing proficiency and established infrastructure. As part of the collaboration, REGENXBIO has already initiated with WuXi the production of material to be used in planned clinical trials.
"This partnership leverages WuXi's world-class commercial biologics manufacturing and characterization capabilities, enabling us to develop top-quality manufacturing processes that we can use to advance our NAV Technology gene therapies into the clinic and ultimately through to commercial markets," said Ken Mills, President and CEO of REGENXBIO. "In addition, the proximity of WuXi's new facility to both REGENXBIO's corporate headquarters in Rockville, Maryland, and Dr. Jim Wilson's lab at the University of Pennsylvania is expected to help facilitate a successful collaboration. We look forward to working with WuXi and view this partnership as an important step toward getting meaningful gene therapy treatments to patients."
"This unique collaboration enables WuXi to work closely with REGENXBIO to provide an integrated solution to its gene therapy needs," said Dr. Ge Li, Chairman and CEO of WuXi AppTec. "We are proud to have been chosen by REGENXBIO to manufacture NAV Technology treatments at clinical and commercial scale to the highest quality standards."
REGENXBIO Inc. is the leading next-generation AAV gene therapy company, developing a new class of personalized therapies based on its proprietary NAV® Technology platform for a range of severe diseases with serious unmet needs. NAV Technology includes novel AAV vectors AAV7, AAV8, AAV9, and AAVrh10. REGENXBIO has enabled global partners including Dimension Therapeutics, Baxter Healthcare, AveXis, Audentes Therapeutics, Voyager Therapeutics, Fondazione Telethon, Lysogene, Esteve, and AAVLife to use its NAV Technology. For more information about REGENXBIO, please visit www.regenxbio.com.
About WuXi PharmaTech
WuXi PharmaTech (NYSE:WX) is a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides pharmaceutical, biotechnology, and medical device companies with a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi is also building a platform to provide clinical diagnostic services directly to physicians and their patients globally. WuXi PharmaTech's services are designed to help its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. The operating subsidiaries of WuXi PharmaTech are known as WuXi AppTec. For more information about WuXi AppTec, please visit www.wuxiapptec.com.
REGENXBIO Elizabeth Broder (Investors) +1 646-378-2945 Todd James (Investors) +1 646-378-2926 Annie Starr (Media) +1 973-415-8838 WuXi AppTec Ronald Aldridge (Investors) +1 201-585-2048 Aaron Shi (Media) +8621-5046-4362