CDMO Genezen buys uniQure Hemgenix plant for $25m

The deal sees contract development and manufacturing organization (CDMO) Genezen agree to buy the plant for $25 million, half of which will be in Series C Preferred Stock and half in a convertible note.

The sale fulfils one of uniQure’s key goals of reducing cash burn, spokesperson Tom Malone told BioProcess Insider. “The proposed divestiture streamlines uniQure’s operations and represents an important milestone in our ongoing efforts to significantly reduce expenses.

“The divestment of this single asset allows us to save approximately $40 million per year and still have access to a world-class manufacturing facility as a preferred customer for our clinical and R&D needs.”

The facility produces Hemgenix (etranacogene dezaparvovec), which in 2022 became the first gene therapy to win US Food and Drug Administration (FDA) approval for hemophilia B. It also became the most expensive drug in the world with a list price of $3.5 million.

CSL Behring commercializes the adeno-associated virus (AAV) based therapy having bought the licensing rights from UniQure for $450 million in 2020. uniQure continued to produce drug substance and drug product from the 80,000 square-foot facility in Lexington, but Malone said the Lexington site will become a secondary supplier after CSL initiated the process of undertaking a tech-transfer for the manufacture of Hemgenix.

However, with the sale Genezen will continue to supply CSL from Lexington “for as long as CSL chooses,” Malone told us, “certainly until the tech transfer process that CSL is embarking on is complete, which is expected to still be some time down the road from now.”

He added: “Genezen was also able to employ the vast majority of employees at the facility, which was important to us. We believe that this is a win-win for both companies.”

A Genezen spokesperson confirmed most staff will make the transition from uniQure and told us: “The deal adds significant capability and scale to the business by adding a commercially licensed facility and team. We are now able to provide our customers with preclinical to commercial vector development and manufacturing services across our sites.”

The facility, which will serve as Genezen’s AAV center of excellence and commercial manufacturing site, also complements the CDMO’s existing clinical manufacturing operations in Indianapolis, Indiana.