Roche has said a delay in the U.S. regulatory review of its $4.3 billion takeover of Spark Therapeutics is “not unusual.” But a third delay is anything but normal.
The Swiss drugmaker is postponing the refiling of its premerger notification and report form to the Federal Trade Commission for a third time, this time for two weeks to around May 23, the pair said Tuesday. The reason, again, is that the antitrust agency needs more time to complete its evaluation, according to the companies.
Just when—if ever—will the deal close? “There is no change in assumptions,” a Roche spokesperson told FiercePharma in a statement. “We expect it will be completed according to our guidance in the first half of 2019.”
It may be understandable if an FTC review takes longer when two large companies with potential business overlap are merging, such as with Bayer’s $62 billion acquisition of Monsanto. But major stalling on a less-than-$5 billion deal, as in the Roche-Spark case, is quite uncommon in the biopharma world. Roche, though—just as it did with the second extension unveiled in April—insisted that the delay “is not unusual in a transaction of this type.”
Is there any possible antitrust risk that requires careful examination on the FTC’s part? It doesn’t appear so. Spark is known as a gene therapy specialist with Luxturna as the first FDA-approved treatment of its kind. But Roche is new to gene therapy and is counting on the takeover to tap into the booming area.
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Hemophilia A seems like the most likely scenario where combining the two companies’ businesses could create a formidable force. Roche’s hemophilia A therapy Hemlibra is already growing rapidly, and Spark’s experimental gene therapy SPK-8011 could serve as a follow-up. But there are clear rivals out there.
BioMarin’s valoctocogene roxaparvovec is already ahead of SPK-8011 in development, and earlier results also indicated it might be a better contender than the Spark drug. An early-phase gene therapy from uniQure, called AMT-180, also holds potential to treat all hemophilia A patients regardless of inhibitor status as Hemlibra does, the company said last November.
Repeated regulatory delays are just one problem with the Spark merger. Fewer and fewer Spark investors have tendered their shares as endorsement for the merger, forcing Roche to push back its offer further to June 14. As of May 13, about 21.0% of Spark’s outstanding shares had been tendered, Roche said, down from 26.1% on Apr. 25, which was itself lower than the 29.4% from early April.
Roche had previously tried to play down the decline, explaining that “a significant portion of shareholders customarily tender their shares during the last day of the tender offer period.” It also insisted that the decline is no indication of lack of support.