Roche’s headquarters in Basel, Switzerland

Regulators have finally given Roche the green light to complete its acquisition of gene therapy developer Spark Therapeutics.

The Basel, Switzerland-based drugmaker said Tuesday that it had completed its $4.3 billion deal to acquire Philadelphia-based Spark, which will continue to operate as an independent company within Roche. Roche had said Monday that the Federal Trade Commission and the U.K.’s Competition and Markets Authority closed their 10-month investigation into the deal and whether it would harm competition in the hemophilia A treatment space. Spark’s website now includes a pop-up stating that it is part of the Roche Group.

“We are excited about this important milestone because we believe that together, Roche and Spark will be able to significantly improve the lives of patients through innovative gene therapies,” Roche CEO Severin Schwan said in a statement. “This acquisition supports our long-lasting commitment to bringing transformational therapies and innovative approaches to people around the world with serious diseases.”

The deal had been announced in February, but was delayed amid concerns among regulators that Roche could have an incentive to delay or discontinue development of Spark’s Phase III gene therapy for hemophilia A, SPK-8011, given that the Swiss drugmaker already markets a potentially market-leading therapy for the disease, Hemlibra (emicizumab-kxwh). Spark markets the first gene therapy to win Food and Drug Administration approval, Luxturna (voretigene neparvovec-rzyl), for an inherited form of blindness.

“The evidence developed during staff’s investigation did not indicate that Roche would have the incentive to delay or terminate Spark’s developmental effort for its hemophilia A gene therapy, or that the acquisition would affect Roche’s incentives regarding Hemlibra,” read a statement about the conclusion of the investigation from the FTC. “Among other things, Apark is only one of several companies developing a gene therapy treatment for hemophilia A. as the other companies endeavor to bring their gene therapies to market, Roche would have the incentive to accelerate, rather than decelerate the development of Spark’s gene therapy in order to compete for gene therapy patients.”

Other companies developing gene therapies for hemophilia A include BioMarin, which has a gene therapy called BMN 270 (valoctocogene roxaparvovec) in Phase III development, and Sangamo Therapeutics, which is partnered with Pfizer in the development of its Phase I/II candidate, SB-525.

Photo: Roche