US clears Novartis' deal with GlaxoSmithKline, contingent on sale of BRAF, MEK inhibitors

The US Federal Trade Commission said Monday that Novartis agreed to divest all assets related to its experimental BRAF and MEK inhibitors in order to gain antitrust clearance for its $16-billion acquisition of GlaxoSmithKline's portfolio of cancer drugs. Last month, Novartis agreed to sell global rights to the experimental BRAF inhibitor encorafenib to Array BioPharma for an undisclosed sum. The Swiss drugmaker had previously reached a deal to return full rights to the experimental MEK inhibitor binimetinib to Array.

In its decision, the FTC stated that if the transaction proceeded as planned, Novartis would likely delay or terminate the development of its BRAF and MEK inhibitors as single products and in combination. The regulator noted that as a consequence, Novartis' acquisition of GlaxoSmithKline's cancer therapies would "likely cause significant competitive harm in the US markets for both the BRAF and MEK inhibitors, ultimately raising prices for consumers and depriving them of potentially superior products."

According to the FTC, under the terms of the proposed consent agreement, Novartis is required to provide transitional services to Array to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition is not reduced. The agency noted that it worked with several antitrust authorities in other markets, including the European Commission, which granted clearance to the asset swap last month after both companies agreed to divest certain products.

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