NPS Pharmaceuticals Inc announced that its licensee, Amgen Inc of Thousand Oaks, CA, has submitted a new drug application (NDA) to the United States Food and Drug Administration seeking approval to market cinacalcet HCl as a therapy for the treatment of secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients. Cinacalcet HCl is the first NPS compound to be the subject of an NDA. Under the terms of its license agreement with Amgen, NPS will receive a milestone payment of $6 million as a result of this regulatory filing.

Cinacalcet HCl is Amgen's first small molecule therapeutic and represents an important milestone for Amgen and furthers the company's commitment to the nephrology community. It also represents a potentially significant advance for chronic kidney disease patients diagnosed with SHPT, a common yet serious metabolic disorder where parathyroid hormone levels are elevated. Patients with this disease can suffer from bone disease, bone pain and fractures, soft tissue calcification, vascular calcification and cardiovascular complications.

Cinacalcet HCl is an oral compound with a unique mechanism of action that modulates the behavior of the calcium-sensing receptor on the parathyroid gland. By increasing sensitivity of the receptors to calcium levels in the bloodstream, cinacalcet HCl may lead to a reduction in the levels of parathyroid hormone, calcium, phosphorous and the calcium-phosphorous product. Currently, there are no therapies available that have these features.

"As a first-in-class compound, cinacalcet HCl is an important new therapy for a serious medical condition in CKD patients," said Hunter Jackson, NPS Chairman and CEO. "We are extremely proud of our role in discovering this compound and congratulate Amgen on successfully reaching this important point in the development of this promising new therapy for secondary hyperparathyroidism. Submission of this NDA also represents an important milestone for NPS and another step toward our goal of becoming a fully integrated pharmaceutical company. Looking ahead, we believe the NPS portfolio of products has the potential to achieve similar success in a variety of therapeutic areas."

Amgen licensed cinacalcet HCl from NPS in 1996. Under the agreement with NPS, Amgen has the right to sell the compound on a worldwide basis except in Japan, Korea, Taiwan, and China where rights to the molecule have been licensed to the pharmaceutical division of Kirin Brewery. In addition to the milestone payment due NPS related to filing the NDA, Amgen will pay NPS royalties on sales of cinacalcet HCl if the drug is approved for marketing.