Merck KGaA is enrolling over 900 women in a late-stage trial testing its cancer vaccine Stimuvax as a treatment for breast tumours, despite not having results from earlier-stage studies, Bloomberg reported. The move has triggered concern with some analysts, who said the drugmaker should have waited for data from late-stage trials in patients with lung cancer before starting new tests.

Helvea analyst Odile Rundquist called the vaccine a “high-risk, high-reward asset,” and estimated that “conservative” annual sales if approved may reach 350 million euros ($519 million) in 2017, falling short of the $1 billion Merck CEO Karl-Ludwig Kley said in 2008 Stimuvax could potentially generate. Kley noted that the company is taking “completely normal risks” with the vaccine.

WestLB analyst Cornelia Thomas said that if Merck is to achieve its sales targets for Stimuvax, then it will probably need to receive approval in additional indications to lung cancer, which the drugmaker said it plans to file for in 2012.

Reference Articles

Breast cancer vaccine tests German Merck’s $1 billion strategy - (Bloomberg)