Astellas Celebrates the Opening of Its New Large-Scale Gene Therapy Manufacturing Facility in North Carolina

- 135,000 square-foot state-of-the-art gene therapy manufacturing facility located in Sanford, N.C., officially opened June 8

- Facility to support clinical- and commercial-scale manufacturing of Astellas' adeno-associated virus (AAV) vectors for gene therapies

- Astellas' $100 million investment in Lee County facility to support more than 200 new jobs

TOKYO and SANFORD, N.C., June 8, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the opening of a new late-stage clinical and commercial manufacturing facility in Sanford, N.C. The facility will allow the company to expand its resources and team to establish a robust, global supply chain and expand its therapeutic and geographic scope.

"Our new manufacturing facility symbolizes our company's continued dedication to the advancement of novel life-changing gene therapies for patients with severe diseases and a significant unmet need, as well as our commitment to the Sanford community," said Mathew Pletcher, Ph.D., Senior Vice President and Division Head of Gene Therapy Research and Technical Operations at Astellas Gene Therapies. "This state-of-the-art facility builds on our existing manufacturing network in Tsukuba, Japan, and South San Francisco, California, and will serve as a major driver of our pipeline, partnerships, and technology. This new facility is a key enabler of our mission to develop safe, effective, and transformative gene therapies as swiftly as possible. As such, Sanford's manufacturing capabilities will allow us to produce materials for multiple programs in parallel as opposed to in sequence and offer commercial-scale manufacturing ability to any future approved therapies. This is critical to rapidly advance our programs and drive the next phase of growth for Astellas."

Through the expansion of Astellas' integrated global manufacturing infrastructure, the company is working to increase its manufacturing capabilities and achieve greater scalability and affordability for gene therapies. The Sanford facility enables continual learning and efficient knowledge-sharing, helping to improve the pace and effectiveness of drug development. The 135,000 square-foot standalone facility will be good manufacturing practices (GMP) compliant and is designed to provide clinical- and commercial-scale manufacturing capabilities for Astellas' pipeline of AAV gene therapies. The company's $100 million investment will also support global supply chain needs and in-house quality control testing, as well as the creation of more than 200 jobs through 2026. The new facility located at 6074 Enterprise Park Drive joins the vibrant biopharmaceutical research and manufacturing community established in Lee County.

"Sanford, North Carolina is a premier location for Astellas Gene Therapies to expand its manufacturing operations," said Governor Roy Cooper. "Our state's skilled workforce, leading academic institutions and healthy business environment provide all the resources they need to foster innovation and continued success."

With the establishment of the Astellas Gene Therapies Center of Excellence following the 2020 acquisition of Audentes Therapeutics Inc., Astellas is a leader in genetic medicines, working alongside its world-renowned partners to build a portfolio of potentially life-changing gene therapies. Astellas strives to identify, develop and deliver transformative therapies for patients with genetic diseases who currently have few or no effective treatment options.

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+^® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines with the potential to deliver transformative value for patients. Based on an innovative scientific approach and industry leading internal manufacturing capability and expertise, we are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown and will also advance additional Astellas gene therapy programs toward clinical investigation. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, N.C. 

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

SOURCE Astellas Pharma Inc.