After rebounding from FDA setback, uniQure goes all in on gene therapy with $55M Corlieve buy

uniQure
UniQure is buying Corlieve Therapeutics to beef up its gene therapy pipeline. (uniQure)

Two months after the FDA lifted a clinical hold on its hemophilia gene therapy, uniQure is throwing down some cash for another.

The Dutch biotech will pay 46.3 million euros ($55 million) upfront in cash to acquire French gene therapy company Corlieve Therapeutics. The boards of both companies have approved the transaction, with completion anticipated in the early third quarter pending review by French authorities, according to a Tuesday press release.

Shareholders seemed to react negatively to the news, with uniQure's shares dropping nearly 7.5% to $30.43 apiece as of 3:49 p.m. ET. 

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UniQure picks up Corlieve's lead program, a gene therapy using miRNA silencing technology, to treat temporal lobe epilepsy (TLE), which affects about 1.3 million people in the U.S. and Europe. The program targets suppression of aberrantly expressed kainate receptors in the hippocampus, the company said. 

The program, known as AMT-260, is a collaboration with Regenxbio, which has equity in Corlieve and is eligible to receive milestone payments and royalties.

As part of the uniQure deal, Corlieve will also receive up to 43.7 million euros ($52.1 million) for development milestones through phase 1/2 and another 160 million euros ($191 million) for phase 3 and approvals in the U.S. and EU. 

“The groundbreaking work of the Corlieve team, in collaboration with Drs. [Christophe] Mulle and [Valerie] Crepel, has led to compelling preclinical results in temporal lobe epilepsy that we believe can strategically leverage uniQure’s leading position in developing and delivering gene therapies that employ miRNA silencing technology," said uniQure CEO Matt Kapusta in a statement. "We look forward to welcoming the Corlieve team into the uniQure family as we join forces to advance this important and potentially transformative therapy into clinical studies."

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The acquisition comes on the same day uniQure revealed positive 52-week clinical data from the HOPE-B pivotal gene therapy trial. The therapy, called etranacogene dezaparvovec, was previously subject to an FDA clinical hold after a patient who received it was diagnosed with cancer, but the agency allowed the trial to continue in April.

UniQure said the company held talks with the FDA earlier this month and expects to seek approval for the therapy in the first quarter of next year with its partner, CSL Behring.