Genezen to Acquire Massachusetts Gene Therapy Manufacturing Operations from uniQure
The acquisition of uniQure’s Lexington, Mass., manufacturing operations will boost Genezen’s late-phase and commercial gene therapy development and manufacturing services.
Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com
Genezen, a gene therapy contract development and manufacturing organization (CDMO), and uniQure, a gene therapy company, announced on July 1, 2024 that they have entered into an agreement under which Genezen will acquire uniQure’s commercial gene therapy operations in Lexington, Mass., for a total consideration of $25 million. The transaction price consists of $12.5 million of newly issued Series C preferred stock and a convertible note valued at $12.5 million. Matt Kapusta, uniQure’s CEO, will join the board of Genezen at closing of transaction, which is expected early in the third quarter of 2024, according to an uniQure company press release.
Under the agreement, Genezen will be responsible for manufacturing global commercial supply of CSL Behring’s HEMGENIX (etranacogene dezaparvovec-drlb), an adeno-associated virus (AAV) vector-based gene therapy approved in the United States and Europe for treating adults with hemophilia B (1,2).
The Lexington site is a commercially licensed viral vector facility. Its acquisition will enable Genezen to offer services from preclinical development programs through to late-phase and commercial manufacturing. The facility also houses state-of-the-art laboratory space and a pilot plant that is expected to serve as a global AAV center of excellence for Genezen and to complement Genezen's existing clinical manufacturing operations and team in Indianapolis, Ind.
"I am thrilled to welcome the Lexington team and the addition of a state-of-the-art, licensed viral vector manufacturing facility to Genezen,” said Steve Favaloro, president and chief executive officer, Genezen, in a Genezen press release. “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. 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."
The acquisition agreement marks a significant step forward for uniQure in achieving a key strategic goal. “We have been focused on meaningfully reducing costs while maintaining our ability to develop and potentially commercialize our gene therapy product candidates. This transaction achieves these objectives by unlocking significant cost savings while maintaining preferential access to world-class gene therapy manufacturing,” Kapusta said in the uniQure press release.
Kapusta also explained that UniQure is continuing to closely review its business to identify additional opportunities for cost reduction. The company expects to announce further progress toward its goal in the third quarter of 2024. “We believe a more streamlined uniQure enhances our strategic flexibility for value-creating opportunities and furthers our mission to deliver transformative medicines for patients in need,” Kapusta stated in the release.
References
1. FDA. HEMGENIX BLA approval letter. fda.gov, Nov. 22, 2022.
2. EMA. Hemgenix Product Information Page. ema.europa.eu (accessed July 3, 2024).
