Amgen Inc., claims to be the world's largest biotechnology company, has initiated a landmark trial- TREAT-to evaluate the impact of treating anaemia on cardiovascular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes. TREAT (Trial to Reduce cardiovascular Events with Aranesp (darbepoetin alfa) Therapy) is one of the largest clinical trials in the company's 25-year history. The TREAT study design as well as additional Sensipar data was presented at the American Society of Nephrology (ASN) annual meeting in St. Louis.

"Current research suggests that anaemia is an augmenter of cardiovascular risk in individuals with CKD and type 2 diabetes," TREAT lead investigator Marc Pfeffer, chief of medicine at Brigham and Women's Hospital and a professor at Harvard Medical School said adding, "TREAT will be the definitive study to determine if treating anaemia with Aranesp does, in fact, lower the risk of death and non-fatal cardiovascular events in individuals with CKD and type 2 diabetes."

TREAT is an international 4,000 patient, multi-centre, randomized, double-blind, placebo-controlled trial. The primary endpoint of TREAT is a composite index of time to mortality or non-fatal cardiovascular event, including myocardial infarction, myocardial ischemia, stroke and heart failure.

Anaemia is a common complication of CKD and becomes more common as kidney function declines. Aranesp has been shown to be effective in correcting anaemia with less frequent dosing than other treatments. In TREAT, patients will receive Aranesp once monthly, which is the same dosing approved by the European Committee for Medicinal Products for Human Use (CHMP) in August 2004.

"The work surrounding the initiation of TREAT and the continued studies for Sensipar demonstrate Amgen's commitment to treating grievous illnesses and improving the lives of patients with chronic kidney disease," said Beth Seidenberg, chief medical officer and senior vice president of global development at Amgen.

Additional study results presented at ASN collectively confirm that Sensipar enables significantly more patients to achieve the four key National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) bone metabolism and disease goals independent of vitamin D dose.

Sensipar data from 210 patients in the phase 3 studies demonstrated that Sensipar sustained reductions in parathyroid hormone (PTH) and calcium-phosphorus product out to one year of treatment. In two additional phase 3b studies where vitamin D doses were reduced, Sensipar enabled significantly more patients to achieve the K/DOQI targets for PTH and calcium-phosphorus product as compared to the baseline values. In one 3b study, Sensipar was highly effective in controlling PTH while simultaneously lowering calcium-phosphorus product in patients who were within the K/DOQI target range for PTH but above the range for calcium-phosphorus product.

"The one-year study results further confirm that Sensipar effectively lowers PTH and the calcium-phosphorus product offering dialysis patients the benefit of long-term control of secondary HPT," said David Bushinsky, study investigator, University of Rochester. "The additional clinical trials emphasize that Sensipar simultaneously controls the four key parameters, PTH, calcium-phosphorus product, calcium and phosphorus, of secondary HPT and is efficacious with small doses of vitamin D," he added.

On October 26, the European Medicines Evaluation Agency approved marketing authorization in the European Union (EU) following a positive opinion issued in July from the CHMP. The drug will be marketed as Mimpara (cinacalcet) in the EU.

Aranesp was approved by the US FDA in September 2001 for the treatment of anaemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anaemia in patients with nonmyeloid malignancies.

Amgen licensed Sensipar from NPS Pharmaceuticals Inc. in 1996. Amgen has applied for regulatory approval in Australia and New Zealand. Approval has been granted in Canada.