USA— The Federal Trade Commission (FTC) in the US is taking more time to review the proposed merger between two diabetes drug developers, Sanofi and Provention Bio.
Sanofi had to withdraw and refile its proposal to acquire Provention Bio in order to give the FTC more time to complete its review.
This effectively reset the FTC’s 15-day preliminary review clock for a cash tender transaction and the agency now has until the end of April 25 to make a decision. Sanofi is extending its offer to buy all of Provention’s shares by six days to the end of April 26.
Sanofi is aiming to take over Provention at a cost of US$25 per share in a deal valued at US$2.9 billion.
Despite the FTC delay, Sanofi still expects to close the deal in the second quarter of this year. The centerpiece of the deal is Tzield, the first and only FDA-approved treatment to delay the onset of Type 1 diabetes.
Type 1 diabetes is a genetic disease where the body’s immune system attacks the insulin-producing cells in the pancreas, while Type 2 diabetes is often linked to lifestyle factors and occurs when the body doesn’t make enough insulin or doesn’t use insulin effectively.
Despite the differences between the two types of diabetes, Sanofi is hoping to acquire Provention Bio, which would enable them to take over Tzield, the first and only FDA-approved treatment to delay the onset of Type 1 diabetes.
Sanofi views the proposed takeover of Provention as a strategic fit, building on a previous co-promotion pact, under which Sanofi lent its commercialization expertise.
However, the Federal Trade Commission (FTC) is taking longer than expected to review the proposed acquisition, leading Sanofi to withdraw and refile its proposal.
The FTC has until April 25 to make a decision, resetting the 15-day preliminary review clock for a cash tender transaction. Sanofi has extended its offer to buy all of Provention Bio’s shares by six days until April 26.
Meanwhile, the biopharma industry is eagerly awaiting the FTC’s ruling on Pfizer’s proposed US$43 billion acquisition of cancer drug developer Seagen.
In a potential bid to resolve any anti-competition concerns, Pfizer recently ended its long-term collaboration with Merck KGaA on the PD-L1 inhibitor Bavencio.
The FDA had approved Bavencio as a front-line maintenance treatment for bladder cancer patients who had responded to chemotherapy in 2020.
Last week, the FDA approved a combination of Seagen’s antibody-drug conjugate Padcev and Merck & Co.’s PD-1 inhibitor Keytruda as a front-line treatment for bladder cancer patients who couldn’t take cisplatin-based chemotherapy.
If Pfizer were to acquire both Bavencio and Padcev in bladder cancer, it could potentially raise concerns at the FTC. The focus is now on whether the FTC will approve both the Sanofi-Provention and Pfizer-Seagen deals.
In recent years, the FTC has been lenient in its review of major deals involving drugmakers, though it is currently trying to unwind the already-closed US$8 billion merger between medtech companies Illumina and Grail.
Despite this, longer review periods have become increasingly common. Sanofi, for instance, had to refile its US$3.2 billion acquisition of Translate Bio in 2021 to give the FTC more time for review.
Similarly, the FTC has sent Amgen and Horizon Therapeutics a second request for information on their US$28 billion merger, a deal that Sanofi lost to Amgen.
However, the recent resignation of Republican Commissioner Christine Wilson could complicate the agency’s future enforcement actions.
Wilson had previously expressed concern about the FTC’s aggressive antitrust approach to biopharma deals.
Her departure could thus leave the agency in flux regarding its stance on future deals, including Sanofi’s proposed acquisition of Provention Bio.
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