EMA accepts Merck, Ariad sarcoma drug filing

Merck & Co and partner Ariad Pharmaceuticals moved a step closer to EU approval for cancer treatment ridaforolimus yesterday when the European Medicines Agency agreed to start reviewing their marketing application for the drug.

Ridaforolimus is an experimental oral mTOR inhibitor developed as a treatment for patients with metastatic soft-tissue or bone sarcomas who were previously responsive to chemotherapy. Earlier this year, the two companies reported data from the SUCCEED trial showing that the drug induced a significant 28% reduction in the risk of disease progression in these patients compared to placebo.

Merck and Ariad have also filed for approval of ridaforolimus in the USA for the same indication, and will learn in the next 60 days whether the Food and Drug Administration has accepted this for review.

Analysts at Cowen & Co said on the publication of the SUCCEED trial results that the data on ridaforolimus should be sufficient to win approval, and if a green light is forthcoming the drug  could achieve sales in excess of $350 million by 2015.

There are currently limited treatment options for patients with sarcomas - a relatively rare group of cancers affecting the connective tissue of the body - and there is a pressing need for new therapies.

The mTOR inhibitor class looks set to have potential in other cancers as well, with the first entrant in the category - Novartis' Afinitor (everolimus) - approved in the USA last year for second-line treatment of advanced renal cell carcinoma. Merck and Ariad also have ridaforolimus in early- to mid-stage clinical testing for endometrial, breast and ovarian cancers, as well as renal cell carcinoma.

The two companies entered into a licensing deal for the drug in May 2010, under which Merck is responsible for the development and marketing of ridaforolimus in oncology, while Ariad has co-promotion rights in the USA.