New Findings Provide Additional Insights into the Management of Anaemia and Secondary Hyperparathyroidism in Chronic Kid

ECHO is the first pan-European, multicentre, observational study to explore Mimpara(R) use in daily "real-world" clinical practice. 1,865 patients were enrolled between July 2005 and October 2007 from 187 sites in 12 countries. This was a part retrospective and part prospective study of patients receiving dialysis who received Mimpara(R) for the treatment of SHPT. Data for eligible patients were collected through chart review. The study collected relevant retrospective data for the 6 months before the start of Mimpara(R) therapy and retrospective/prospective data for the 12 months after commencement of therapy.

About CKD Anaemia

Anaemia is one of the most common symptoms of CKD. It occurs when failing kidneys no longer produce sufficient erythropoietin, a hormone that stimulates the production of oxygen-carrying red blood cells (RBCs) that contain haemoglobin, an iron-rich protein that carries oxygen from the lungs to the body's tissues.

Anaemia can be a serious disease that is often under-diagnosed and under-treated.(9) When anaemia occurs, the body gets less oxygen and therefore has less energy than it needs to function properly. The major symptoms of anaemia include fatigue, weakness, shortness of breath, difficulty concentrating or confusion, dizziness or fainting, pale skin, rapid heartbeat and feeling unusually cold.

About SHPT

Secondary hyperparathyroidism (SHPT) is a metabolic disorder that develops in chronic kidney disease (CKD) patients on dialysis and results in increased secretion of parathyroid hormone (PTH), which may lead to bone disease, bone pain and fractures, cardiovascular and soft tissue calcification and parathyroid hyperplasia.

SHPT develops as the parathyroid gland secretes increased PTH to normalise blood levels of calcium, which are low in patients with CKD. While SHPT initially helps to normalise serum calcium, over time, continuous PTH secretion leads to excessive growth of the parathyroid gland, high levels of PTH, calcium and phosphorus in the blood, and complications including bone disease and soft tissue and vascular calcification, which increases the risk for cardiovascular events.

K/DOQI sets out targets for the key parameters implicated in SHPT: parathyroid hormone (PTH; target 150-300 pg/mL), calcium (Ca; target 8.4-9.6 mg/dL) and phosphorus (P; target 3.5-5.5 mg/dL).

The majority of an estimated 324,000 CKD patients on dialysis in Europe suffer from some degree of SHPT.

About Aranesp(R)

Aranesp(R) is a therapy for the treatment of anaemia in chronic kidney disease (CKD). It is a novel recombinant erythropoiesis stimulating agent (ESA) that maintains haemoglobin levels in the blood by stimulating red blood cell (RBC) production.(6)

Aranesp(R) was granted marketing authorisation by the European Commission in 2001 for the weekly (QW) treatment of anaemia associated with chronic renal failure in adults and children of 11 years of age or older. In 2004, approval was granted for an extended dosing schedule for Aranesp in the nephrology setting, meaning that for the first time, CKD patients not on dialysis could receive Aranesp(R) on a once monthly basis (QM). In 2006, the Aranesp(R) SmPC was updated to allow CKD patients on dialysis to switch from a rHuEPO dosing schedule of two to three times a week to once every two weeks (Q2W) with Aranesp. In 2007, the European Commission approved Aranesp(R) for the treatment of CKD anaemia in paediatric patients on/not on dialysis.

Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to Aranesp(R) with Q2W dosing. The initial Q2W dose of Aranesp(R) (micrograms/every other week) is determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200.(5)

About Mimpara

Mimpara(R) (also known as Sensipar(R) in the United States, Australia, New Zealand and Canada) is a calcimimetic agent that is approved for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease receiving dialysis.(10)

Mimpara is a first-in-class calcimimetic that modulates the activity of the calcium-sensing receptor. It is a small molecule that acts as an allosteric modulator of the calcium-sensing receptor (CaR) on the parathyroid cell surface. The primary role of the CaR is control of parathyroid hormone (PTH) secretion in response to extracellular calcium concentration. Cinacalcet acts to reduce circulating PTH concentration through activation of the CaR by increasing its sensitivity to extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statement

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