UK Regulator Unconditionally Clears Roche’s Purchase of Spark Therapeutics

The UK Competition and Markets Authority (CMA) announced Monday the clearance of Roche’s proposed purchase of Spark Therapeutics after concluding that the deal would not negatively affect competition for haemophilia A treatments. The Swiss drugmaker noted that the offer period under the transaction, which is still being reviewed by US regulators, is currently scheduled to expire on December 19.

Roche reached an agreement in February to buy Spark for $114.50 per share in cash, or approximately $4.3 billion, in an effort to bolster its haemophilia A portfolio with the addition of experimental gene therapies, including SPK-8011. The Swiss drugmaker, which currently markets Hemlibra (emicizumab) for the treatment of patients with haemophilia A with or without factor VIII inhibitors, said at the time that the purchase was expected to close in the second quarter.

However, Roche has had to extend the offer period for the deal on a number of occasions, initially noting in April that a review of the transaction by the US Federal Trade Commission (FTC) was taking longer than anticipated. Meanwhile, the CMA opened an investigation into the proposed purchase in June, later seeking comments from any interested parties as part of its probe.

On Monday, the CMA said that while gene therapies, such as SPK-8011, are likely to compete with Hemlibra in the future, there are a number of other companies developing gene therapy treatments. The regulator added that Spark’s “products are not currently considered to hold any particular clinical or commercial advantages over those being developed by other suppliers.” The CMA added that there are also “several innovative non-gene therapy products under development that are likely to become viable alternatives to Roche and Spark’s treatments.”

The CMA said that it has closely cooperated with the FTC as part of its investigation. A report recently suggested that staff at the US regulator recommended that Roche’s proposed purchase of Spark be approved without requiring the sale of any assets.