>>SALT LAKE CITY, March 8 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP - News) announced today that its licensee, Amgen Inc. (Nasdaq: AMGN - News) of Thousand Oaks, CA, has received approval from the United States Food and Drug Administration to market Sensipar (cinacalcet HCl) for the treatment of secondary hyperparathyroidism (secondary HPT) in chronic kidney disease (CKD) patients on dialysis, and for the treatment of elevated calcium levels (hypercalcemia) in patients with parathyroid carcinoma. Under the terms of its license agreement with Amgen, NPS will receive a milestone payment of $10 million as a result of this regulatory approval.
Sensipar is Amgen's first small molecule therapeutic and the first NPS compound to be approved for patient use. Sensipar also represents a significant advance for chronic kidney disease patients diagnosed with secondary HPT, 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. Sensipar is also a significant advance in the treatment of hypercalcemia in patients with parathyroid carcinoma.
Sensipar is an oral compound with a unique mechanism of action that modulates the behavior of calcium receptors on the parathyroid gland. By increasing sensitivity of the receptors to calcium levels in the bloodstream, Sensipar reduces levels of parathyroid hormone, calcium, phosphorous, and calcium-phosphorous product. Currently, there are no therapies available that have these features.
"We are delighted with the approval of Sensipar," said Hunter Jackson, Ph.D., NPS Chairman and CEO. "Since the time of our discovery of calcimimetic compounds in the early 1990's we've looked forward to the day when these unique compounds could provide benefits to people suffering with renal and parathyroid disorders. We're grateful that the labors of the talented people at NPS and Amgen have been rewarded by providing a first-in-class therapy to people whose lives will be extended and improved as a result of that work. We hope that this will be the first of many similar events for NPS products as we move forward with our other drug development efforts."
Amgen licensed calcimimetic compounds from NPS in 1996 and will pay NPS royalties on product sales. Under the license 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.<<
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My understanding is that Amgen got an approvable letter for predialysis patients. Today's sell-off is apparently due to speculation that AMGN/NPSP would get that now. Amgen will be conducting trials in that indication. Given the insurance environment regarding oral medications for these indications, it might not make much difference in terms of the revenues they will get in the first couple of years. Hence, this seems a little overdone. Preos news should be coming soon, including data on osteosarcoma in humans. Disclosure: I have a covered write on this one.
Cheers, Tuck |
