After months of hype, the results from a long-awaited trial show that denosumab reduced the risk of verterbral fractures in post-menopausal women by 68 percent compared with those given a placebo.
This places Amgen's med on a par with Novartis' Reclast drug, which is the most effective on the market. Although some investors hoped denosumab's effectiveness would exceed 70 percent, the results suggest Amgen has a very competitive product in a big market. The stock is up more than 5 percent in the first hour of trading after the findings were made public.
The three-year study involved 7,808 women and found that 60 mg of denosumab given every six months reduced the risk of new vertebral fractures by 68 percent versus placebo - 2.3 percent on denosumab versus 7.2 percent on placebo, a statistically significant result. Treatment with denosumab also reduced hip fracture risk by 40 percent and nonvertebral fracture risk by 20 percent, according to a filing with the Securities and Exchange Commission.
The data, which is being presented this morning at the American Society of Bone Mineral Research in Montreal, also showed a rate of infection of 4.1 percent among denosumab patients compared with 3.4 percent in the placebo arm.
"Everyone has been hoping this was a clean drug and it has emerged as that," Eric Schmidt, an analyst at Cowen, tells Reuters. "And the efficacy data for denosumab, at face value, are as good as anything else" now on the market.
However, one Amgen investor, who has been a vocal critic, says the results are disappointing. "In my estimation, this is somewhat of a let down...It seems to me, and based partly on past experience, in order for Denosumab to be a mega blockbuster, it would have to be a lot better. For now, it's just another competitor," says Steve Silverman (back story).