Amgen and NPS Pharmaceuticals Announce Initiation of a Phase 3 Trial of a Calcimimetic in the Treatment of Secondary Hyperparathyroidism.

Business/Medical Editors

THOUSAND OAKS, Calif., and SALT LAKE CITY--(BUSINESS WIRE)--Dec. 20, 2001

Amgen (Nasdaq:AMGN) and NPS Pharmaceuticals (Nasdaq:NPSP) today announced the initiation of a phase 3 clinical trial of an investigational calcimimetic, AMG 073, in the treatment of secondary hyperparathyroidism (HPT), a serious disorder associated with renal disease. The trial triggers a $3 million milestone payment to licensor NPS Pharmaceuticals, Inc.

"We believe that AMG 073 could be an important treatment for kidney disease patients whose medical needs are not currently met," said Dr. Roger Perlmutter, Amgen's executive vice president of research and development. "This represents Amgen's first small molecule to enter phase 3 trials. We are very pleased with the progress of the calcimimetics program."

AMG 073 is in a class of orally active compounds, known as calcimimetics, which increase the sensitivity of the calcium-sensing receptor on the surface of the parathyroid gland, thereby inhibiting the secretion of excessive amounts of parathyroid hormone. Data from phase 2 trials in patients with secondary HPT were presented at the American Society of Nephrology meeting earlier this year.

"Commencement of a phase 3 trial is an important milestone for NPS," said Hunter Jackson, chief executive officer of NPS Pharmaceuticals. "We believe calcimimetic therapy represents an exciting and novel approach to managing secondary hyperparathyroidism."

Secondary HPT is commonly seen in patients with renal failure. According to the National Kidney Foundation, over 85 percent of the more than 250,000 patients with end-stage renal disease undergoing dialysis in the United States suffer from secondary HPT. In addition, many patients with chronic renal insufficiency also suffer from secondary HPT.

Secondary HPT is characterized by enlargement of the parathyroid glands and elevated circulating levels of parathyroid hormone. As renal function deteriorates, the body is unable to maintain proper levels of calcium and phosphorus in the blood. To compensate, parathyroid glands enlarge and produce increased amounts of parathyroid hormone. Chronically elevated parathyroid hormone levels can lead to bone loss and pain, bone deformities, severe generalized itching and abnormal calcification of soft tissues, including the heart. Current therapies include phosphate binders and vitamin D analogs, neither of which act directly on the calcium sensing receptor of the parathyroid gland.

Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.

NPS Pharmaceuticals discovers, develops and intends to commercialize small molecule drugs and recombinant proteins, primarily for bone and mineral disorders and central nervous system disorders. The Company has six drugs in various stages of clinical development and several preclinical product candidates. As a result of the start of the phase 3 clinical trial, NPS has also earned an additional $3 million milestone payment under its agreement with Kirin Brewery Company  Limited involving calcimimetics in Asia. Additional information on NPS is available on the company's Web site, http://www.npsp.com.

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 Amgen's 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, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of Amgen's 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 obtain patents for its products and technology, the protection offered by Amgen's patents and patent applications may be challenged, invalidated or circumvented by Amgen's 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 December 20, 2001, and expressly disclaims any duty to update information contained in this press release.

Statements included within this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause actual results to differ materially from those described herein. There can be no assurance that NPS drug candidates, including AMG 073, will prove to be safe and/or efficacious or successfully marketed and sold. Careful consideration should be given to cautionary statements made in NPS documents filed with the SEC, in particular the NPS' Form 10-K.

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