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AMGEN: Prolia’s (denosumab) Approval in Europe is Great News

Prohost Biotech - Tuesday, June 01, 2010
June 1, 2010 - Postmenopausal women at increased risk of bone fractures from osteoporosis, and men with prostate cancer who suffer bone loss associated with hormone ablation treatment will finally get Amgen’s (AMGN) drug Prolia (denosumab) in Europe. The good news for these patients and for Amgen (AMGN) has come as the European Medicines Agency’s (EMEA) Commission has granted approval for the use of Prolia in both conditions. Suddenly, Prolia has been approved in 27 European Union member states plus Norway, Iceland and Liechtenstein. The European approval of Prolia marks the first approval of the product worldwide and the first and only approval in Europe for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

If approval was expected as many Wall Street analysts are stating now, why then such expectations, which also leads to expectations for billions of dollars to be generated by the drug were not reflected on the stock price, which went south instead of flying north? In addition to the drug’s proven efficacy and fast action, as demonstrated in clinical trials, the drug is convenient to take through a subcutaneous injection given every six months. All six clinical studies have demonstrated Prolia's ability to increase bone mineral density at all skeletal sites measured.

The market for Prolia is expected to be huge. Despite widely available treatments, specialists have always been eager to have new options that can really prevent bone fractures. Prolia might be the answer, as its approach innovative. The drug has a new target, RANK Ligand and has proven to tremendously reduce the risk of fracture in both postmenopausal women and prostate cancer patients who receive hormone ablation treatment. The pivotal three-year FREEDOM (Fracture, REduction, Evaluation of Denosumab in osteoporosis) study in 7,808 women with postmenopausal osteoporosis demonstrated a 68 percent reduction in the relative risk of suffering a new vertebral fracture compared to those receiving placebo. It also demonstrated a 40 percent reduction in the relative risk of suffering a hip fracture and a 20 percent reduction in the relative risk of suffering a non-vertebral fracture at 36 months. 

The some success with Prolia was demonstrated on prostate cancer patients who received hormone treatment ablation.  Results from the pivotal HALT (Hormone Ablation Bone Loss Trial) study in 1,468 men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer showed a 62 percent reduction in the relative risk of suffering a new vertebral fracture with Prolia compared to placebo at 36 months, with significant reduction observed as early as month 12.  

The market for osteoporosis is huge and osteoporosis is a serious disease that can significantly impact the lives of millions of women. Despite widely available treatments, new options that could protect against fractures were lacking.  The European approval was most needed for the patients and for Amgen. The drug is expected to generate billions of dollars and to be approved for more indications, including delaying cancer metastasis in bone.  

Amgen has a collaboration agreement with GlaxoSmithKline for Prolia for the postmenopausal osteoporosis indication in Europe, Australia, New Zealand and Mexico. It will be responsible for commercializing the product for all indications where Amgen lacks marketing presence. The selection of Glaxo as a partner is excellent as per this firm’s strong marketing presence in these areas. The expected approval of Prolia in the U.S. next July 25, 2010 will be tremendous news that promises adding billions of dollars in revenues into Amgen’s coffers. Prohost believes that AMGN is undervalued and has stock in one of its portfolio that comprises top-tier biotech stocks.
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