USA-based Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, announced top-line results of the Phase III Aranesp (darbepoetin alfa) RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial, showing the study did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (Hazard Ratio 1.01, 95% CI 0.90, 1.13).
The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target hemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL), or placebo.
Analysts at Credit Suisse have a worldwide net present value for Aranesp of $7.56/share (10% of total) for Amgen. Aranesp is approved as a treatment for anemia caused by chronic kidney disease, and for patients who have anemia due to chemotherapy. Aranesp sales were $2.3 billion in 2011, having reached as high as $4.1 billion in 2006.
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