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Will Denosumab Strengthen Amgen's Bones?

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Sometimes the devil really is in the details.

Investors already knew that Amgen's (Nasdaq: AMGN  ) osteoporosis treatment, denosumab, worked. They just didn't know how well. The biotech giant reported in July that the drug had passed its phase 3 trial, but only just released the detailed data at a medical conference.

Passing its phase 3 trial will help get denosumab on the market. But two big questions remain: how well it worked, and whether anyone will buy it, given the drug's plentiful rivals. Between GlaxoSmithKline's (NYSE: GSK  ) Boniva, Novartis' (NYSE: NVS  ) Reclast, Eli Lilly's (NYSE: LLY  ) Evista and Forteo, and generic versions of Merck's (NYSE: MRK  ) Fosamax, simply being better than a placebo is not enough. To gain market share, your drug must beat the competition.

The data presented at the American Society of Bone and Mineral Research showed that denosumab cut the risk of spinal fractures by 68%, and hip fractures by 40%, compared to placebo. However, that's pretty comparable to how Reclast performed. The hip fracture numbers weren't as good as Fosamax's 51% improvement, but Fosamax didn't improve spinal fractures nearly as well, either, so that's a wash.

To satisfy my scientific background, I need to tell you that comparing numbers between trials isn't very scientific, because different populations of patients were enrolled in each trial. But that caveat doesn't keep doctors and analysts from drawing such comparisons, as I just did.

Ultimately, denosumab's ability to make a dent in the market probably depends on which method of drug delivery patients and doctors prefer. Reclast is given via a 15-minute infusion once a year, while denosumab is injected twice a year, and Fosamax is a once-daily pill. There's no clear-cut winner there. Only time will tell which will win.

Investors seem to have liked what they saw -- Amgen was up 6% yesterday. Still, I have to wonder whether investors weren't just pumped up about any good news at all, given all of this week's turmoil.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Eli Lilly and Glaxo are Income Investor recommendations. Try any of our Foolish newsletters today, free for 30 days. The Fool has a disclosure policy.


Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On September 19, 2008, at 12:46 PM, ahold wrote:

    This analysis is very skimpy and has several mistakes. First the mistakes:

    1. Fosamax is sold under two formulations, daily and weekly. In the Dmab study, the weekly formulation was studied, not daily as the article states.

    2. It is vertebral fracture, not spine fracture. A fracture of the spine leads to paraplegia, quadriplegia, etc depending on the site. A fracture of the vertebrae can range from being asymptomatic to causing pain to leading to spinal problems.

    Now the skimpy analysis.

    1. The article just mentioned efficacy results at three years. The fracture efficacy of Alendronate (Fosamax) was SUPERIOR to Dmab in the head to head study. Dmab was superior to Placebo in the 3 year study.

    2. There was no mention of safety in this article.

    3. There was no mention of pharmaco-economics. Generic Fosamax versus an expensive biologic such as Dmab. What are the implications?

  • Report this Comment On December 01, 2008, at 6:31 PM, edtoddy wrote:

    There was no head to head study of alendronate vs. Dmab with a fracture endpoint. Probably not feasible due to the number of patients needed for a superiority study.

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