We currently earn royalties on (i) Amgen’s sales of Sensipar® (cinacalet HCl), (ii) Nycomed’s sales of Preotact®, which is our PTH 1-84 that is marketed for the treatment of osteoporosis in the European Union, and (iii) Kyowa Kirin’s sales of REGPARA® (cinacalcet HCl) in Japan.  We have also licensed the ex-North American rights to teduglutide to Nycomed and the two companies are collaborating on the STEPS study for short bowel syndrome.  Below is a summary of key partnered products and licensing arrangements.

Amgen/Sensipar® and Mimpara®

We licensed worldwide rights (with the exception of previously licensed Asian territories) to Amgen to develop and commercialize cinacalcet HCl for the treatment of hyperparathyroidism.  We recognize royalties on Amgen’s sales of cinacalcet HCl; however, Sensipar royalties are paid directly to a restricted cash account of a subsidiary of ours and used to repay non-recourse debt issued in December 2004 and August 2007.  After repayment of the debt, Sensipar royalties will return to us. 

Approved by the Food and Drug Administration (FDA) in March 2004, Sensipar® is an oral medication for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma. To regulate parathyroid hormone (PTH), Sensipar® acts directly on the parathyroid gland calcium-sensing receptor.

Sensipar® is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium.  Secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) is a progressive disease, associated with increases in parathyroid hormone (PTH) levels and derangements in calcium and phosphorus metabolism. Increased PTH stimulates osteoclastic activity resulting in cortical bone resorption and marrow fibrosis. The goals of treatment of secondary hyperparathyroidism are to lower levels of PTH, calcium, and phosphorus in the blood, in order to prevent progressive bone disease and the systemic consequences of disordered mineral metabolism. In CKD patients on dialysis with uncontrolled secondary HPT, reductions in PTH are associated with a favorable impact on bone-specific alkaline phosphatase (BALP), bone turnover and bone fibrosis. The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion. Sensipar® directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels. 

Sensipar® is indicated for the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease on dialysis.  Sensipar® is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma.  For more information visit http://www.sensipar.com.

Kyowa Kirin/ REGPARA® (cinacaclet HCl)

NPS has an agreement with Kyowa Kirin to develop and commercialize cinacalcet HCl for the treatment of hyperparathyroidism in the countries of Japan, China, North and South Korea, and Taiwan. Kyowa Kirin launched cinacalcet HCl as REGPARA® tablets in Japan in the first quarter of 2008.  REGPARA tablets were approved in Japan in October 2007 for secondary hyperparathyroidism during maintenance dialysis.  NPS is currently receiving royalties on Kyowa Kirin’s sales of REGPARA.

Nycomed/PREOTACT®

We have licensed the ex-US rights to Preotact® (full-length parathyroid hormone [PTH 1-84]) to Nycomed.  Nycomed is responsible for European clinical development, registration and marketing and we are entitled to royalty revenue.  Our Preotact royalties are paid directly to DRI Capital (formerly Drug Royalty Corporation) in accordance with non-recourse debt issued in July 2007.  The Preotact royalties will return to us if royalty payments to DRI exceed two and one-half times the amount of advanced principal, including any future sales-based milestone payment from DRI to NPS.

Preotact® is approved in the EU for the treatment of osteoporosis in post-menopausal women at high risk of fractures. Preotact contains recombinant human parathyroid hormone, which is identical to the full-length native 84-amino acid polypeptide.  Physiological actions of parathyroid hormone include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular reabsorption of calcium and excretion of phosphate by the kidney.  Preotact is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures.  For more information visit http://www.preotact.net.

Nycomed/Teduglutide

In September 2007, we granted Nycomed the right to develop and commercialize teduglutide outside of North America.  We received $35.0 million in up-front fees under the agreement. Under the terms of the agreement, we have the potential to earn up to $190.0 million in development and sales milestone payments.  Additionally, the agreement provides for double-digit royalties on GATTEX sales in the licensed territories.  We are advancing our Phase 3 STEPS study of GATTEX in SBS with Nycomed on a collaborative basis and the two companies are sharing external clinical trial costs.