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|First-In-Class Oral Calcimimetic Shown To Reduce Parathyroid Hormone Levels In Chronic Kidney Disease|
|FOR IMMEDIATE RELEASE
PHILADELPHIA, PA, November 3, 2002 - Amgen (Nasdaq: AMGN), the world's largest biotechnology company, today announced phase 2 data for Amgen's investigational compound AMG 073 (cinacalcet HCl) suggesting that AMG 073 can reduce and maintain parathyroid hormone (PTH) levels within the target range in end stage renal disease (ESRD) patients with secondary hyperparathyroidism (HPT). Elevated PTH is associated with bone pain, fractures, and increased mortality risk. The data was presented at the 35th annual meeting of the American Society of Nephrology (ASN).
Data were also presented that suggest that AMG 073 may also reduce the frequency of self-reported cognitive problems (such as confusion, difficulty thinking, and forgetfulness) in patients with secondary HPT. The improvement seen in the AMG 073 group was due, at least in part, to reductions in PTH.
Achieving Target PTH Levels
"AMG 073 reduced PTH levels to the target range in the majority of these patients who were not previously controlled with standard care," said Dr. Block. "These results demonstrate the potential benefit of AMG 073 as a novel therapy for the chronic treatment of secondary hyperparathyroidism. Because AMG 073 appears to reduce PTH without increasing Ca x P levels, it may offer advantages over current therapies." [ASN poster # SU-P0509; Block, et al]
Promising New Class and Compound
Phase 3 trials for AMG 073 were launched December 2001.
Other AMG 073 Studies Presented at ASN
Two-Year Treatment with Calcimimetic AMG 073 in Hemodialysis Patients with Secondary Hyperparathyroidism
Self-Reported Cognitive Functioning in Hemodialysis Patients with Secondary Hyperparathyroidism: The Effect of the Calcimimetic AMG 073 Prior research in animal models and humans suggests that high levels of PTH may impair cognitive function in patients with secondary HPT. Reducing and maintaining target levels of PTH may lower the frequency of self-reported cognitive problems (e.g., confusion, difficulty thinking, forgetfulness, etc.) in patients with secondary HPT. This pooled analysis of two phase 2 studies suggests that the frequency of self-reported cognitive problems may be reduced with AMG 073, as compared to placebo, at least in part due to reductions in PTH. Larger controlled studies are needed to further clarify these findings. [ASN poster #SU-P0800; Chertow, et al.]
The Effects of One-Year Treatment with the Calcimimetic AMG 073 on Bone Health in ESRD Patients with Secondary Hyperparathyroidism
Amgen also developed Aranesp® (darbepoetin alfa) which provided another option in anemia treatment that resulted in a unique molecule with an approximately three times longer half-life and greater biological activity than Epoetin alfa with the added benefit of less-frequent dosing schedules, while also retaining a similar safety profile.
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 more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical field where movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product.
Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of our products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers. These government regulations and reimbursement policies may affect the development, usage and pricing of our products.
In addition, while Amgen routinely obtains patents for our products and technology, the protection offered by Amgen patents and patent applications may be challenged, invalidated or circumvented by our competitors.
Because forward-looking statements involve risks and uncertainties, actual results may differ materially from current results expected by Amgen. Amgen is providing this information as of November 3, 2002 and expressly disclaims any duty to update information contained in this press release.
CONTACT: Amgen Inc.
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