Genezen Purchases uniQure’s Gene Therapy Operations in Massachusetts
The deal provides the CDMO with ownership of the Lexington facility, allowing for late-phase and commercial gene therapy development and manufacturing of a branded severe Hemophilia B product.
Genezen, a gene therapy contract development and manufacturing organization (CDMO), will be acquiring uniQure's commercial gene therapy operations in Lexington, MA, which adds a manufacturing plant and a team of employees into the mix.1
Per the deal, Genezen would enter into strategic supply agreements for both uniQure's clinical portfolio and CSL's commercial HEMGENIX product, a one-time gene therapy approved that has been proved in the United States and Europe for the treatment of severe and moderately severe Hemophilia B in adults.
The Lexington plant is a commercially-licensed viral vector facility, allowing Genezen to assist customers from preclinical development programs, all the way through the late-phase and commercial manufacturing process. There is even laboratory space—along with a pilot plant—that will serve as Genezen's global adeno-associated virus (AAV) center of excellence. This acquired Lexington plant joins the likes of the CDMO’s Midwest clinical manufacturing operations team in Indianapolis, IN.
"I am thrilled to welcome the Lexington team and the addition of a state-of-the-art, licensed viral vector manufacturing facility to Genezen. This acquisition significantly enhances Genezen's scale and differentiated capabilities, directly aligned with our mission to advance cell and gene therapies by providing top-tier, science-driven development and manufacturing solutions,” said Steve Favaloro, president and CEO of Genezen. “We are honored to deliver these services to our current customers and the patients they serve, and are well positioned to immediately extend our support to even more customers in Lexington."
Members of the uniQure team also look forward to the growth opportunities that lie ahead.
"uniQure has been a pioneer in gene therapy manufacturing for the past 15 years, and we are pleased to have found a partner in Genezen to take the facility and team into its next phase of growth," commented Matt Kapusta, CEO of uniQure. "This transaction provides us with continued access to the world-class manufacturing capabilities we established and the talented, dedicated people who support the facility every day. We look forward to beginning our collaboration with Genezen and are committed to ensuring a seamless transition."
Mike Deem, head of CSL Behring Operations also expressed that, "We are excited to expand our relationship with Genezen and have them take on HEMGENIX commercial supply from the Lexington manufacturing operation, continuing to optimize the manufacturing process and help us ensure a reliable supply for patients."
In other news, the CDMO and Seattle Children's Research Institute, the research division of Seattle Children's Hospital, reached a manufacturing partnership for Seattle Children's Research Institute's X-linked agammaglobulinemia (XLA) program.2 Genzen’s current good manufacturing practice (cGMP) and viral vector process know-how will be utilized to help progress the institute’s gene therapy program centered around the rare primary immunodeficiency condition defined by low levels of immunoglobulins, or antibodies.
"I am extremely excited for our team to support the world-class researchers at Seattle Children's Research Institute as they progress their XLA gene therapy into the clinic,” added Favaloro. “With this program, Seattle Children's is one of our first customers to leverage our Cytegrity producer cell line offering from CSL. The Genezen team is dedicated to a science-first, service-focused approach for our innovator clients—I know our team will add tremendous value to Seattle Children's Hospital and XLA patients."
References
1. Genezen to Acquire uniQure's Commercial Gene Therapy Manufacturing Operations in Lexington, MA. PR Newswire. July 1, 2024. Accessed July 3, 2024. https://www.prnewswire.com/news-releases/genezen-to-acquire-uniqures-commercial-gene-therapy-manufacturing-operations-in-lexington-ma-302186384.html
2. Genezen Announces Strategic Process Development and Manufacturing Partnership Agreement with Seattle Children's Research Institute for X-linked Agammaglobulinemia (XLA) Cell Therapy Program. PR Newswire. March 6, 2024. Accessed July 3, 2024. https://www.prnewswire.com/news-releases/genezen-announces-strategic-process-development-and-manufacturing-partnership-agreement-with-seattle-childrens-research-institute-for-x-linked-agammaglobulinemia-xla-cell-therapy-program-302080874.html?tc=eml_cleartime
Operating Without a Commercial Blueprint: Empowering the Field for Niche Therapy Launches
October 24th 2024How emerging biotech companies can create fruitful partnerships between home office commercial teams and the field force to enable this intelligence gathering, while driving commercial success.
