Boulder, Colorado-based Array BioPharma will acquire the assets as part of the deal. Under the terms of the proposed consent agreement, Novartis is required to provide most of the leg work to keep the potential treatments on track in their development, which includes transitional and manufacturing support to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in these markets is not reduced.
“Array is well suited to acquire LGX818 and MEK162 because it initially developed MEK162 and is currently a partner with Novartis in the development of both products,” the FTC said.
In order to address competition concerns raised by the European Commission, Array also has agreed to obtain an experienced partner for global development and European commercialization of both of the developing drugs, known as binimetinib and encorafenib.
Physicians use BRAF and MEK inhibitors separately, and increasingly in combination, to treat melanoma. Both products are also being developed to treat a variety of other cancers.
According to a complaint filed with the FTC, Swiss-based Novartis and London-based GSK are two of a small number of companies with either a BRAF or MEK inhibitors currently on the market or in development, and two of only three companies marketing or developing a BRAF/MEK combination product to treat melanoma.
The FTC said that if the acquisition had moved forward without the divestment, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product, which “would likely cause significant competitive harm in the US markets,” according to the FTC.
The FTC voted 5-0 to accept the complaint and proposed consent order for public comment. The agreement will be subject to public comment for 30 days, after which the Commission will decide whether to make the proposed consent order final.
The FTC also said it worked with staff of the antitrust agencies in Australia, Canada, and the European Union on the proposed transaction and potential remedies. “This coordination led to compatible approaches on a global scale, and included FTC and European Commission approval of Array BioPharma as the buyer of the divested assets,” the commission said.