Could Spark Therapeutics’ merger with Roche finally get the go-ahead?

Spark Therapeutics’ merger with Roche has moved a step closer after the UK’s competition watchdog okayed the $4.8 billion deal, ahead of a regulatory deadline later today in the US.

The gene therapy firm agreed a deal to merger with the Swiss pharma giant in February, but completion has been repeatedly pushed back while competition regulators deliberated over the deal.

After unconditional clearance by the UK’s Competition and Markets Authority, the only remaining barrier is the Federal Trade Commission, which is still mulling over the deal.

But the CMA said it had cooperated closely with the FTC in making its decision, suggesting that Roche may get the merger over the line later today, which marks the end of the review period under US antitrust regulations.

The CMA explained that it had been examining whether the deal could negatively affect future treatment choices for haemophilia A in the UK.

Spark is developing gene therapy treatment for haemophilia, while Roche already makes Hemlibra, a recently approved prophylactic injection designed to reduce bleeds in patients with the blood disease.

In a statement outlining the thinking behind its decision, the CMA said that gene therapy treatments are likely to compete with Hemlibra in the future.

But the CMA found that Spark is not the only supplier developing its gene therapy treatment, and its products are not considered to have any clinical or commercial advantages over those being developed by other suppliers.

BioMarin and Sangamo Therapeutics are also developing gene therapies for haemophilia A, with the former considered to be closest to market with its valoctocogene roxaparvovec, or valrox.

The CMA’s investigation also found that there are several innovative non-gene therapy products under development that are likely to become viable alternatives to Roche and Spark’s treatments.

The CMA therefore found that the deal between Roche and Spark would not negatively affect competition because UK health services and patients will still have an adequate choice of alternatives.