The old saying goes, “good things come to those who wait”— but in Sanofi’s case, more waiting on US regulators to approve its Translate Bio buyout is likely far from a good thing.
On Aug. 27, Sanofi and Translate refiled their premerger notification with the FTC after the agency indicated in “informal discussions” that it needed more time to review the biotech and pharma giant’s tie-up, Translate said in an SEC filing.
The new deadline for the FTC’s review is Sept. 13, but that could be extended if the FTC opts to deny the merger approval of Translate files for more time, the biotech said.
“Withdrawing and refiling pre-merger notifications is a standard procedure in order to provide additional time for antitrust review of certain transactions,” Translate said. “(Sanofi) and (Translate) continue to work cooperatively with the FTC in its review of the proposed transaction, and continue to expect to complete the transaction subject to the satisfaction or permitted waiver of the conditions to closing.”
While Sanofi and Translate pooh-pooh the delay, it comes amid a much more wary review process at the FTC, which under the Biden administration has telegraphed its intent to not be viewed as a rubber stamp for industry. So far, in the first half of the year, M&A in biopharma has been mostly restricted to deals of this type — minor bolt-ons that are a far cry from deals like the $63 billion pact AbbVie and Allergan signed last year.
If the pushback does escalate, it would represent a thorn in the side of Sanofi and CEO Paul Hudson, who has looked to turn the pharma’s vaccine arm into a next-gen mRNA powerhouse on a par with its large competitors.
In early August, Sanofi announced it would buy out Translate, a prior collaborator on the French drug giant’s push into mRNA vaccines, for a cool $3.2 billion. Sanofi, just a year before, shelled out $425 million and $1.9 billion in biobucks to expand its existing collaboration with Translate, and the merger made that escalating dalliance official.
The original partnership, signed in 2018, gave Sanofi global rights to any of Translate’s mRNA products for infectious disease, which could set the drug giant up for a future role as a leader in next-gen cell therapy. The pact was signed under the onus of Sanofi Pasteur, the drugmaker’s massive vaccines arm.