Germany's Merck KGaA is barreling ahead with ambitious clinical trial plans for its cancer vaccine Stimuvax, convinced that it has a potential blockbuster drug on its hands. The pharma company is recruiting 900 patients for a breast-cancer study and says it plans to seek its first regulatory approval in 2012.
But Merck's strategy for Stimuvax, which is designed to spur the immune system to target cancer cell, has aroused some intense skepticism among analysts watching the company. Some have questioned why the German company would roll straight into a large clinical trial before it gets a chance to analyze final data from smaller trials. And at a cost of about $146 million, Merck KGaA's upcoming clinical trial is attracting fresh scrutiny of its R&D spend, which has risen so fast that it cut into its third quarter earnings.
Merck, though, isn't showing any signs of reluctance--or slowing down, notes an in-depth article at Bloomberg. CEO Karl-Ludwig Kley tried to assure investors that the company is taking a completely normal risk in pursuit of a possible first-line treatment.
Merck KGaA's strategy for Stimuvax highlights both the risks and rewards in the cancer vaccine field. Antigenics is the only developer to have achieved a regulatory win--a questionable advance in Russia--for a cancer vaccine. But regulators in the U.S. have proven much harder to convince. With IMS estimating that the cancer market will mushroom from $48 billion to $75 billion in 2012, though, biopharma companies are betting big that cancer vaccines will grab a big slice of the market. Bloomberg highlights three: Dendreon's Provenge, which may hit the market by the middle of next year, Accentia's lymphoma vaccine and a lung cancer therapy in development at Glaxo.