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
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
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
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
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.
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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
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(i)EPOGEN(R) is a registered trademark of Amgen Inc.
(ii)Procrit(R) is a registered trademark of Ortho Biotech
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-4587 (media)
Laura Biswas, 805-447-1060 (investors)
SOURCE: Amgen Inc.