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Today Amgen Inc. (AMGN) announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for its potential next blockbuster drug, denosumab. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six phase-III trials involving more than 11,000 patients.
Denosumab is a fully human monoclonal antibody target receptor activator of nuclear factor kappa B ligand (RANK-L). The clinical data on denosumab, or D-Mab as management calls it, is impressive. In July 2008, Amgen release top-line data from the pivotal trial testing denosumab in 7,800 women with postmenopausal osteoporosis over a 3-year period. Data from the trial showed taking denosumab subcutaneous injections once every six months resulted in statistically signficiant reduction in the incidence of vertebral fractures compared to placebo.
Amgen noted that secondary endpoints of incidence in non-vertebral and hip fractures were also statistically reduced in the denosumab group. The hip fracture endpoint was particularly encouraging considering how difficult this endpoint has been to hit in preivous PMO studies by competitors. Amgen also recently released data from a phase-III study for the treatment of bone loss in men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer. The results show a statistically signficant increase in bone mineral density and a 50% reduction in new vertebral fractures.
In May 2008, Amgen offered up impressive head-to-head data testing denosumab in 250 post-menopausal women with low bone mass. The results from this one-year study showed that once every six month subcutaneous injections of denosumab resulted in superior bone mineral density (BMD) at all points tested than once-weekly oral alendronate (Merck's {MRK} Fosamax).
Specifically, denosumab resulted in a 40% improvement in BMD at the total hip (3.5% vs. 2.5%, p<0.0001) after one year. Other secondary endpoints, including lumbar spine, femoral neck, trochanter and distal radius all also showed a statistically significant improvement over Merck's drug. This is the second pivotal program to demonstrate switching to denosumab from Fosamax results in superior BMD. Merck's Fosamax posted worldwide sales of $3.05 billion in 2007.
Additional data at the American Society of Clinical Oncology (ASCO) meeting in June 2008 demonstrated that denosumab increased BMD (at all sites) in women with non-metastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy. Results from the phase-III HALT study show that denosumab increased bone density worsened by AI therapy, including in highly cortical areas of the skeleton.
We think these data squarely place denosumab superior to Merck's Fosamax. The benefit of denosumab is in the wider range of efficacy and significantly less frequent dosing of once every 6 months vs. weekly Fosamax. The head-to-head Fosamax trial discussed above will be key to convincing the market denosumab is a blockbuster. Our financial model assumes Amgen received approval and launches D-Mab in early 2010. By 2013, we expect sale to eclipse $2.6 billion.
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