Roche delays Spark merger again amid reviews in US and UK

Roche’s $4.3 billion takeover of US gene therapy specialist Spark Therapeutics has been pushed back again because regulators are concerned over its impact on competition.

The company hoped to have the takeover done and dusted by now, but US antitrust authorities have asked for more time to review the transaction.

The companies had hoped to file pre-merger documents in March, then delayed until 9 May before extending the filing to 29 May.

This latest delay pushes the deadline back to July 31 and has been caused by a request for more information from the US Federal Trade Commission, in connection with its review.

The UK’s Competition and Markets Authority has also opened an investigation, although there has been no official statement about the issues that are holding up the deal.

The FTC does not comment on cases it is reviewing, while the UK regulator is trying to determine whether the deal could hurt competition in Britain.

In previous reviews issues with pharma mergers have been resolved by remedies where certain business units have been sold off to ensure fair levels of competition in the UK market.

Roche is hoping to use the deal to gain access to Spark’s experimental gene therapy for haemophilia A.

The Swiss firm already markets the haemophilia A drug Hemlibra (emicizumab), so gaining access to a gene therapy would put it in a strong position in this market, potentially offering patients a one-shot gene treatment or a powerful prophylactic drug.

Any merger would also set up an interesting situation in ophthalmology, where Roche’s Swiss rival Novartis has European rights to the ophthalmology gene therapy Luxturna for a rare inherited eye disorder.

Roche added that it has already bought around 21.1% of Spark’s shares, although shareholders who have already tendered their Spark shares will not have to re-tender them or take any other action as a result of the delay.