Amgen´s First Small Molecule - Cinacalcet HCl - Receives FDA Priority Review
SAN DIEGO, Nov. 15 -- Amgen (Nasdaq: AMGN), the
world´s largest biotechnology company, announced results of phase 3 studies
evaluating the efficacy and safety of cinacalcet HCl, a first-in-class oral
calcimimetic, administered once daily for the treatment of secondary
hyperparathyroidism (HPT) associated with chronic kidney disease (CKD). These
results were presented at an American Society of Nephrology (ASN) sponsored
symposium in San Diego.
Amgen recently received notification that the U.S. Food and Drug
Administration (FDA) granted a priority review for cinacalcet HCl, a novel
therapeutic that modulates the activity of the calcium-sensing receptor, the
primary regulator of PTH secretion. Cinacalcet HCl is the first
investigational agent to demonstrate simultaneous reductions in parathyroid
hormone (PTH), calcium-phosphorus product, phosphorus and calcium levels to
successfully control secondary HPT. Moreover, cinacalcet HCl may allow
patients to achieve PTH and mineral targets in accordance with the new Kidney
Disease Outcomes Quality Initiative (K/DOQI) Guidelines for Bone Metabolism
and Disease recently published by the National Kidney Foundation.
Secondary HPT develops early during the course of CKD and continues to
progress as kidney function declines and patients begin dialysis. Patients
with secondary HPT can suffer from bone disease, bone pain and fractures, soft
tissue calcification and vascular calcification. The current treatment for
patients with secondary HPT includes phosphate binders and vitamin D sterols,
which may elevate blood calcium and/or phosphorus levels. As a consequence,
treatment is frequently interrupted -- resulting in inadequate control of PTH,
which contributes to disease progression.
"Cinacalcet HCl is an exciting new approach to treating secondary HPT,"
said Dr. Geoffrey A. Block, director of clinical research, Denver
Nephrologists, PC. "Achieving the new K/DOQI guidelines will be challenging
with existing therapies, which often require clinicians to make trade-offs
regarding therapeutic goals. With cinacalcet HCl we may now have the ability
to simultaneously maintain target levels of parathyroid hormone, calcium-
phosphorus product, phosphorus and calcium."
Three phase 3 double-blind, randomized, placebo-controlled studies
including more than 1,100 patients on hemodialysis and peritoneal dialysis
with uncontrolled secondary HPT were conducted in Australia, Canada, Europe
and the U.S. Cinacalcet HCl was titrated to achieve a target PTH level, which
is within the new K/DOQI guidelines. A greater proportion of patients in the
cinacalcet HCl group (36 to 48 percent), compared to those receiving standard
therapy (four to seven percent) achieved the primary endpoint of PTH less than
or equal to 250 pg/mL. Across the phase 3 program, clinically relevant
reductions in calcium-phosphorus product (13 to 17 percent) calcium (six to
eight percent) and phosphorus (seven to 10 percent) occurred in patients
receiving cinacalcet HCl, while they remained at baseline levels in those
receiving standard therapy and placebo. In a separate study in patients with
CKD not requiring dialysis, cinacalcet HCl resulted in reductions in PTH
comparable to those observed in patients with end-stage renal disease
Cinacalcet HCl was highly efficacious regardless of age, gender, race or
disease severity. Cinacalcet HCl was also effective in patients receiving
vitamin D as well as those contraindicated to vitamin D due to hypercalcemia
or hyperphophatemia. The most commonly reported side effects in the clinical
trials with cinacalcet HCl were nausea and vomiting, which were generally mild
to moderate in severity and brief in duration.
"We are pleased that cinacalcet HCl, the company´s first small molecule,
has received priority review by the FDA. This represents an important
milestone for Amgen, furthering the company´s commitment to the patients
suffering from CKD," said Dr. Beth Seidenberg, senior vice president of
development and chief medical officer at Amgen.
Amgen licensed cinacalcet HCl from NPS Pharmaceuticals Inc. and filed a
new drug application (NDA) with the FDA for cinacalcet HCl. Additionally,
Amgen has filed cinacalcet HCl for regulatory approval in Australia, Canada,
the European Union and New Zealand.
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This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below and
others that can be found in our Form 10-K for the year ended December 31,
2002, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is
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Kelly Stoddard, (805) 447-0821 (media)
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