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Cell and Gene Therapy

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UniQure, with Sale of Plant, Outsources Hemgenix Manufacturing

The gene therapy developer plans to sell its Lexington, Massachusetts, facility to Genezen, a CDMO that specializes in viral vector production.

Dive Brief:

  • UniQure will sell a gene therapy production plant in Lexington, Massachusetts, to contract manufacturer Genezen in a deal designed to reduce the biotechnology company’s operating expenses.
  • Genezen will pay UniQure $25 million in stock and debt for the facility, as well as offer employment to the “majority” of UniQure staff currently working at the Lexington site. UniQure expects to lower its cash burn by $40 million a year as a result of the sale.
  • With the deal, UniQure has effectively outsourced manufacturing of Hemgenix, an approved gene therapy for hemophilia B that it licensed to CSL and still produced. Genezen will also provide development and manufacturing services for UniQure’s experimental gene therapy pipeline under a preferred customer agreement.

Dive Insight:

The Lexington plant is a central production hub for UniQure, which describes it as “one of the world’s leading, most versatile, gene therapy manufacturing facilities.” The company has for years pitched it as a competitive advantage in the field, affording it a level of flexibility and control that outsourcing wouldn’t.

But UniQure is in a different position now, having licensed Hemgenix, its only approved treatment, to CSL and facing cost pressures. In October, the company laid off one-fifth of its staff and shuttered a research facility that was also located in Lexington. The gene therapy field has undergone a retrenchment as some of the first therapies to reach market, Hemgenix included, struggle to gain traction.

Meanwhile, UniQure noted in the risk factors section of its latest annual report that its contract to supply Hemgenix to CSL required “the dedication of significant company resources.” Additionally, CSL has plans to transfer manufacturing technology linked to Hemgenix to a third-party contractor in the future.

“Following such transfer, we may experience challenges in adapting our Lexington facility to meet the manufacturing and supply needs for products other than Hemgenix as a result of excess capacity or our ability to adapt to new processes, among other challenges,” UniQure wrote.

The sale will lower the company’s operating expenses while maintaining preferential access to production capacity at the site under Genezen’s ownership.

Matt Kapusta, UniQure’s CEO, will join Genezen’s board of directors under the deal, which the companies expect to close in the third quarter. UniQure said it is continuing to review its operations for other opportunities to cut costs. As of March 31, the biotech had enough cash to fund operations through the second quarter of 2027.

Genezen will fund the transaction in part with equity provided by Ampersand Capital Partners.

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