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|Amgen Launches Landmark Trial to Evaluate the Impact of Treating Anemia on Cardiovascular Risks in Patients with Chronic Kidney Disease and Type 2 Diabetes|
ST. LOUIS--(BUSINESS WIRE)--Nov. 1, 2004--
Sensipar(R) (cinacalcet HCl) Data Also Presented at American Society of Nephrology Meeting Underscores Amgen's Commitment to Chronic Kidney
Disease Patients with Secondary Hyperparathyroidism
Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced that the company has initiated a landmark trial to evaluate the impact of treating anemia on cardiovascular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes. TREAT (Trial to Reduce cardiovascular Events with Aranesp(R) (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(R) data was presented at the American Society of Nephrology (ASN) annual meeting in St. Louis.
"Current research suggests that anemia is an augmenter of cardiovascular risk in individuals with CKD and type 2 diabetes," said TREAT lead investigator Marc Pfeffer, M.D., Ph.D., chief of medicine at Brigham and Women's Hospital and a professor at Harvard Medical School. "TREAT will be the definitive study to determine if treating anemia 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, multicenter, 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.
Anemia is a common complication of CKD and becomes more common as kidney function declines. Aranesp has been shown to be effective in correcting anemia 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. In the U.S., Aranesp is approved to be administered once a week if a patient was receiving Epoetin alfa two to three times weekly. Aranesp should be administered once every two weeks if a patient was receiving Epoetin alfa once per week.
"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, M.D., chief medical officer and senior vice president of global development at Amgen.
Sensipar for the Treatment of Secondary Hyperparathyroidism (HPT)
in CKD Patients on Dialysis
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, M.D., 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."
Prior to the approval of Sensipar, the only available medical treatments for patients with secondary HPT were phosphate binders and vitamin D sterols, which may elevate calcium levels. As a consequence, treatment is frequently interrupted, resulting in inadequate control of PTH. Sensipar provides targeted treatment of secondary HPT with its unique mechanism of action that acts directly on the calcium-sensing receptor, the primary regulator of PTH.
Secondary HPT is characterized by elevations in PTH, calcium and phosphorus levels. If left untreated, patients with secondary HPT can develop bone disease, bone pain and fractures, vascular and soft tissue calcifications, which are frequently associated with an increased risk of hospitalization and death. According to Dr. Bushinsky, "we expect that achieving the K/DOQI targets will be associated with better clinical outcomes."
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(R) (cinacalcet) in the EU.
Aranesp(R) is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the discovery of recombinant erythropoietin, epoetin alfa, which is currently marketed in the U.S. by Amgen as EPOGEN(R) (Epoetin alfa)(i) and by Ortho Biotech Products, LP, as Procrit(R) (Epoetin alfa)(ii). Building on this heritage, Amgen developed Aranesp, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule, resulting in more activity, with the added benefit of less-frequent administration.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia 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 anemia in patients with nonmyeloid malignancies.
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; dose reductions are recommended if the hemoglobin increase exceeds 1.0 g/dL in any two-week period. The most commonly reported side effects in Aranesp(R) trials were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.
Sensipar is an innovative, first-in-class oral calcimimetic indicated for the treatment of secondary HPT in CKD patients on dialysis, and for the treatment of elevated calcium levels (hypercalcemia) in patients with parathyroid carcinoma. On March 8, 2004, after a priority review, Sensipar was approved for marketing by the U.S. Food and Drug Administration.
In clinical trials in patients with secondary HPT on dialysis, Sensipar was safe and effective in reducing PTH, calcium-phosphorus product, calcium and phosphorus in a broad range of patients regardless of age, gender, race, years on dialysis or disease severity. Sensipar was effective in patients receiving vitamin D, as well as those not receiving vitamin D.
In a clinical trial in patients with hypercalcemia due to parathyroid carcinoma, Sensipar lowered calcium levels.
Sensipar is safe and well-tolerated in a broad range of patients. Sensipar lowers serum calcium. Significant reductions in calcium may lower the threshold for seizures. Secondary HPT patients, particularly those with a history of a seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia. The most commonly reported side effects were nausea and vomiting.
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.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2003, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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Note: Copies of the study abstracts are available upon request. Full prescribing information is available on the Web for Aranesp(R) at www.aranesp.com and for Sensipar(R) at www.sensipar.com.
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(i)EPOGEN(R) is a registered trademark of Amgen Inc.
(ii)Procrit(R) is a registered trademark of Ortho Biotech Products, L.P.
CONTACT: Amgen, Thousand Oaks