August 14, 2009
Denosumab, dmab, Prolia -- Amgen's (Nasdaq: AMGN ) drug is known by many names. Unfortunately, this one drug had many different outcomes at its Food and Drug Administration advisory panel meeting yesterday. Rather than the home run investors were hoping for, it looks to me more like a double, with plans to drive the run home.
- The committee recommended approving the drug to treat osteoporosis in postmenopausal women.
- It also recommended approving the drug to treat bone loss in men undergoing hormone ablation for prostate cancer.
- There wasn't enough data to get the committee comfortable with recommending approving the drug for treating women with bone loss due to breast cancer.
- In all three populations, the drug should only be used to treat, not prevent, bone loss. That means it won't be able to grab patients early in their disease progression like Procter & Gamble (NYSE: PG ) and sanofi-aventis (NYSE: SNY ) can with Actonel.
The mildly annoying:
- The committee recommended that the drug have a Risk Evaluation and Mitigation Strategies (REMS) to make sure the right patients get the drug. It's more paperwork for the company, but shouldn't have a major effect on sales.
The FDA doesn’t have to take the advice of the advisory committee -- just ask Schering-Plough (NYSE: SGP ) and Johnson & Johnson (NYSE: JNJ ) about Bridion and Doribax, respectively -- but it seems likely that the agency will approve the drug for at least the treatment of postmenopausal women.
Amgen does have a backup plan if it can't get Prolia to blockbuster status with just osteoporosis patients. It's also testing the drug as a treatment for cancer patients with tumors that have spread to the bone. It's seen mixed results against competitor Zometa from Novartis (NYSE: NVS ) . Prolia beat Zometa in one head-to-head trial, but in a second trial was only shown to be non-inferior. At this point, an approval to treat cancer patients seems likely -- perhaps with another advisory panel meeting -- but how well Prolia will compete against Zometa will likely be determined by a third in-progress head-to-head trial. More mixed results are definitely not what Amgen is looking for.
Is Prolia the savior for Amgen's anemic growth? Let us know what you think in the comments box below.