European Commission Approves Innovative First-in-Class Treatment for a Serious Complication of Chronic Kidney Disease
Amgen Introduces Mimpara(R) Approved to Treat Secondary
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Oct. 28, 2004--
Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology
company, today announced that its first-in-class oral calcimimetic,
Mimpara(R) (cinacalcet), known as Sensipar(R) (cinacalcet HCl) in the
United States (U.S.), has received regulatory approval in the European
Union (EU). Mimpara is now authorized in the EU for the treatment of
secondary hyperparathyroidism (SHPT) in patients with chronic kidney
disease (CKD) on dialysis as well as for the treatment of elevated
calcium levels in patients with cancer of the parathyroid gland.
Hyperparathyroidism in Chronic Kidney Disease Patients on Dialysis
"The approval of Mimpara in the EU is a significant advance in the
management of secondary HPT," said Prof. Jorge Cannata, head of the
Bone and Mineral Unit Hospital Central de Asturias, Oviedo, Spain.
"Mimpara can help reduce parathyroid hormone while at the same time
lower calcium and phosphorus levels, which is consistent with the
K/DOQI(1) clinical practice guidelines for bone metabolism and disease
The majority of an estimated 230,000 chronic kidney disease
patients on dialysis in the EU suffer from SHPT. This serious disease
is characterized by elevations in parathyroid hormone (PTH), and
abnormal calcium and phosphorus levels. If left untreated, SHPT
patients may develop severe bone disease, including bone pain and
fractures. Traditional therapies for SHPT are often limited by
increases in calcium and phosphorus. Elevations in calcium and
phosphorus may lead to vascular and soft tissue calcifications.
Abnormalities in PTH, calcium and phosphorus, which are the hallmark
of SHPT, are associated with an increased risk of hospitalization and
death, often due to cardiovascular disease.
Mimpara's unique mechanism of action acts directly on the
calcium-sensing receptor located at parathyroid gland cells, the
primary regulator of PTH, thereby providing targeted treatment of
In clinical trials, Mimpara has been shown to lower simultaneously
PTH, calcium, phosphorus and calcium phosphorus product levels
resulting in a seven-fold increase in patients reaching K/DOQI target
levels. With conventional therapy only eight percent of patients reach
the four key K/DOQI target levels. In addition, post-hoc analyses of
pooled data from six and 12 months clinical studies, Kaplan-Meier
estimates of bone fracture and parathyroidectomy were lower in the
cinacalcet group compared with the control group.
"Mimpara provides a new way of treating patients with secondary
hyperparathyroidism without the limitations of previous therapies,"
said Beth Seidenberg, chief medical officer and senior vice president
of global development at Amgen. "We are pleased to receive this
approval earlier than anticipated. The unmet medical need of SHPT
patients in the EU can now be satisfactorily and safely addressed with
Today's European Commission Decision follows a positive regulatory
opinion for the approval of Mimpara in the EU, issued on July 29, 2004
by the Committee for Medicinal Products for Human Use (CHMP).
Mimpara is Amgen's first small molecule and represents an
important milestone for the company. Mimpara is marketed as
Sensipar(R) (cinacalcet HCl) in the U.S. and was approved by the Food
and Drug Administration (FDA) in March 2004 for the treatment of
secondary hyperparathyroidism in patients on dialysis and elevated
calcium levels in patients with parathyroid carcinoma following a
CKD is an irreversible condition characterized by decreased kidney
function, which progresses over time. Most patients are not aware they
have the disease until it becomes severe. If diagnosed and treated
early, the progression of CKD may be slowed; however, if left
untreated, the condition may progress to Stage 5 CKD (also referred to
as end-stage renal disease), in which kidney function is no longer
adequate to sustain life and requires dialysis or kidney
transplantation. Without proper treatment to remove wastes and fluids
from the bloodstream, Stage Five CKD is fatal. Some of the serious
complications associated with CKD include cardiovascular disease,
hypertension, anemia, bone disease, as well as SHPT.
As kidney function declines, the calcium and phosphorus balance in
the body is upset, triggering the calcium-sensing receptor, the
principal regulator of PTH secretion located on the surface of the
parathyroid glands, to secrete too much PTH in an effort to restore
balance. SHPT is a serious metabolic disorder characterized by an
imbalance of PTH, calcium and phosphorus -- minerals vital to life and
good bone health.
Management of SHPT can be challenging in part because it is
difficult to lower PTH without the risk of increasing
calcium-phosphorus product, calcium and phosphorus levels. Previously
available treatments for patients with SHPT include phosphate binders
and vitamin D sterols, which may elevate blood calcium levels. As a
consequence, treatment is frequently interrupted -- resulting in
inadequate control of PTH, which contributes to disease progression.
Patients with parathyroid carcinoma have a rare, serious cancer of
the parathyroid glands resulting in excess secretion of PTH. This
disease is complicated by elevated calcium levels in the blood. High
calcium levels can lead to anxiety, depression, nausea, vomiting, bone
fractures, kidney stones and in some cases coma. Surgical removal of
the parathyroid gland is the only curative therapy for this disease
but not successful in all cases.
In clinical trials in SHPT patients on dialysis, Mimpara was
well-tolerated and effective in reducing PTH, calcium, phosphorus
calcium-phosphorus product in a broad range of patients regardless of
age, gender, dialysis method (hemo- or peritoneal dialysis), years on
dialysis or disease severity.
In a clinical trial in patients with hypercalcemia due to
parathyroid carcinoma, Mimpara significantly lowered calcium levels in
the majority of patients.
Based on its mechanism of action, Mimpara lowers calcium, so it
should not be initiated if a patient's calcium levels are below the
lower limit of the normal range. During dose titration, calcium levels
should be monitored frequently and if levels decrease below the normal
range, appropriate steps should be taken to increase calcium levels.
The threshold for seizures may be lowered by reductions in calcium
levels and, infrequently, seizures have been reported, primarily in
patients with a seizure history. The most commonly reported side
effects are nausea and vomiting.
Amgen licensed Mimpara from NPS Pharmaceuticals Inc. in 1996. In
addition to the EU and U.S., Mimpara has also been approved for use in
Canada and submitted for approval in Australia and New Zealand.
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manufactures and markets important human therapeutics based on
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(1)The National Kidney Foundation's Kidney Disease Outcomes
Quality Initiative (K/DOQI) provides evidence- and opinion-based
clinical practice guidelines for all phases of chronic kidney disease
and related complications including bone metabolism and disease in
CKD. K/DOQI is a registered trademark of the National Kidney
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-4587 (media)
Sabeena Ahmad, 011 41 41 3692 530 (European media)
Laura Biswas, 805-447-1060 (investors)
SOURCE: Amgen Inc.