Keyword: Spark Therapeutics
While BioMarin has filed its hem A gene therapy valrox for approvals in the U.S. and EU, Roche is only running a phase 3 lead-in study for SPK-8011.
Roche's $4.3 billion Spark Therapeutics deal is a poster child for extra antitrust scrutiny on biopharma M&As in 2019.
Biopharma M&A got a big boost moneywise in 2019. The three largest delivered more than $150 billion, with Bristol-Myers Squibb's $74 billion takeover of Celgene setting a new record. Oncology was still a hot theme, stringing through a whole year of big dealmaking headlines, just as gene therapy gained popularity.
Gene and cell therapies will make strides in 2020, but their developers will have to address challenges in manufacturing, reimbursement and more.
The 5-0 vote from the five commissioners could ease concerns that the agency has adopted a more stringent criterion in reviewing biopharma M&As.
Though the U.S. FTC has yet to deliver its verdict, the CMA stated that the two authorities have “cooperated closely” in their reviews.
By extending the tender offer for just six days, Roche seems confident it will receive positive reviews from U.S. and U.K. watchdogs in time.
Previously, despite repeated delays, tendered Spark shares stayed relatively stable at around 20%—until now.
Most Spark investors still haven't tendered their shares, despite word of FTC clearance—and the doctor feedback that may have made the difference.
The FTC staff on the Roche-Spark case has reportedly recommended approval of the deal, though top officials will also need to vote on it.