EU approves GSK's Mekinist and Novartis will reap the rewards

GlaxoSmithKline ($GSK) has notched another approval for its novel melanoma med Mekinist, and Novartis ($NVS) gets to celebrate. The drug, which the EU has approved for use there, is among those GSK is selling to the Swiss drugmaker in a $16 billion deal.

The British drugmaker today announced that the the European Commission (EC) had approved Mekinist as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

The drug is already approved in the U.S. as a single use therapy against melanoma, as well as being approved in combo with another GSK drug, Tafinlar. The two work in different ways: Mekinist inhibits cancer cell growth by interfering with a key protein known as MEK while Tafinlar inhibits the action of a mutated BRAF gene. They have the potential to be more effective and longer-lasting together. Approved under the FDA's priority review program, the Tafinlar-Mekinist combination delivered a 76% response rate in a Phase II study, compared with 54% of patients treated with Tafinlar alone.

The EU has asked for more data on the combined use before deciding whether to approve it but that will probably fall to Novartis to handle. That is because Novartis is buying both drugs from GSK, so that Novartis can strengthen its cancer med business. GSK decided to sell them so it could focus in other areas where it feels strong, such as vaccines, HIV meds and respiratory drugs, and have some cash to buy back shares.

Novartis has cancer drugs like blood-cancer drug Gleevec and its follow-up, Tasigna and the kidney cancer treatment Afinitor, which recently won a new approval in breast cancer, but it doesn't have melanoma meds. The Tafinlar-Mekinist duo is expected to reap blockbuster sales. Novartis figures its oncology infrastructure can "optimize" the launch of these two melanoma drugs, "positioning Novartis as the leader in treating melanoma," the company said in a statement. Roche ($RHHBY) may have something to say about that. It has Zelboraf, its own therapy for BRAF-positive melanoma, and analysts have pegged its peak sales at $1.5 billion.

The sale of GSK's cancer business to Novartis was part of a larger deal, valued at $25 billion, in which GSK is also buying most of Novartis' vaccine business and the two decided to combine consumer health. Novartis also agreed to sell its animal health operations to Eli Lilly ($LLY) for $5.4 billion.

- here's the announcement

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