Glaxo Wins Recommendation for Skin Cancer Drug in Novartis Deal

Apr 25, 2014 11:17 am ET

April 25 (Bloomberg) -- GlaxoSmithKline Plc, the U.K.’s biggest drugmaker, won backing from a European Union advisory panel for a skin cancer treatment that was part of its sale of oncology drugs to Novartis AG for as much as $16 billion.

Mekinist was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of melanoma, the most dangerous form of skin cancer, the agency said in a statement today. The European Commission, the EU’s executive arm, usually follows the panel’s recommendation.

Mekinist, which won U.S. approval last year, was one of the cancer drugs that London-based Glaxo announced it was selling to Novartis for $14.5 billion on April 22. If Mekinist is proven effective in combination with Tafinlar, another drug included in the sale, then Glaxo would receive another $1.5 billion from Novartis, based in Basel, Switzerland.

About 132,000 melanoma skin cancers are diagnosed annually, with more than half in the U.S. Almost 10,000 Americans are expected to die from melanoma in 2014, according to the American Cancer Society.

In Europe, about 60,000 cases of malignant melanoma are diagnosed annually, with about 16,000 fatalities.

The drugs from London-based Glaxo target patients who have certain BRAF gene mutations. About half of skin melanomas have a BRAF gene mutation, the U.S. Food and Drug Administration said.