Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma GmbH Enter into Strategic Clinical and Commercial Manufacturing Agreements with bluebird bio

ALLENDALE, N.J. & MUNICH–(BUSINESS WIRE)–Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) and apceth Biopharma GmbH (apceth), both subsidiaries of Hitachi Chemical Co., Ltd. (Hitachi Chemical) today announced that they have expanded their relationship with bluebird bio (NASDAQ: BLUE) with long-term development and manufacturing services agreements for clinical and commercial supply for multiple therapies, including:

• Late stage drug product manufacturing at facilities in both Germany (apceth) and the United States (HCATS) for bluebird bio’s LentiGlobin™ for the treatment of patients with sickle cell disease (SCD) and commercial drug product manufacturing of LentiGlobin™ for SCD in both the United States and Europe
• Expanded commercial drug product manufacturing capacity in Europe for ZYNTEGLO^®▼ (autologous CD34+ cells encoding β^A-T87Q-globin gene), a one-time gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β⁰/β⁰ genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available
• Expanded clinical and commercial manufacturing capacity for bluebird’s investigational Lenti-D for cerebral Adrenoleukodystrophy (CALD) in Europe

These agreements are the latest in a long-standing partnership between bluebird bio and Hitachi Chemical. In 2011, HCATS, which represents the North America region of Hitachi Chemical’s global regenerative medicine business, and bluebird bio entered into their first clinical services agreement. A commercial drug product manufacturing service agreement was also established between bluebird bio and apceth (which represents the Europe region of Hitachi Chemical’s global regenerative medicine business) in 2016. In January 2020, apceth announced its readiness to begin commercial manufacturing of ZYNTEGLO^®▼ with bluebird’s announcement of the launch in Germany.

“With three products in our severe genetic disease franchise to potentially launch between now and 2022, securing long-term commercial drug product manufacturing capacity is critical to our ability to deliver for patients, ” said Nick Leschly, chief bluebird. “Our partnership with Hitachi Chemical is a significant example of our continued progress on this front and we believe Hitachi Chemical’s recent expansion will help support our growing commercial needs. We are pleased to benefit from their expertise as well as their footprint in both the US and Europe as we work to bring transformative therapies to patients in need.”

“We are excited to partner with bluebird bio through our new U.S. facility, utilizing our state-of-the-art capabilities and systems for late-stage clinical testing and ultimately commercial production once all applicable regulatory approvals are granted,” said Robert Preti, Ph.D., Chief Strategy Officer, Hitachi Chemical Life Science Business Headquarters. “It is our honor to support bluebird bio in the manufacture of their potentially transformative gene therapies, to the benefit of patients in both the United States and Europe, as the foundation for our collaboration to address this devastating disease.”

“We are very happy to deepen our trustful and productive strategic partnership with bluebird bio,” commented Dr. Christine Guenther, Deputy General Manager of the Hitachi Chemical Regenerative Medicine Business Sector and CEO of apceth Biopharma GmbH. “The apceth team is proud to be part of bluebird bio’s most exciting pioneering work for the advancement of cell and gene therapies and to supply patients suffering from severe genetic illnesses with potentially life-changing treatments.”

^▼This medicinal product is subject to additional monitoring.

About Hitachi Chemical’s Regenerative Medicine Business

Hitachi Chemical provides cell and gene therapy contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 200,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry.

For more information on North America services, please visit www.pctcelltherapy.com
For more information on Europe services, please visit www.apceth.com
For more information on Japan services, please visit www.hitachi-chem.co.jp/english/

Contacts

Hitachi Chemical Advanced Therapeutics Solutions:

Eric Powers

Director, Marketing and Communications

[email protected]

apceth Biopharma GmbH:

Almut Windhager

Manager, Business Development and Communications

[email protected]