NPS Pharmaceuticals (NPSP) Receives FDA Letter Related to Generic Version of Company's Sensipar
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NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) reported the receipt of Paragraph IV Certification Notice Letters related to certain drug manufacturers' Abbreviated New Drug Applications (ANDA) submitted to the U.S. Food and Drug Administration (FDA) requesting approval to market and sell generic versions of Sensipar (cinacalcet HCl), a drug licensed to Amgen (Nasdaq: AMGN) by NPS.
Under the licensing agreement, Amgen is responsible for all development and commercial activities involving Sensipar, as well as enforcing applicable patent rights, in the licensed territories and NPS is entitled to receive from Amgen royalty payments on sales of Sensipar, as well as certain milestones payments. In 2004 and 2007, NPS partially monetized its rights to receive payments from Amgen through the issuance of Series A and Series B notes, which are non-recourse to NPS. After repayment of this debt, Sensipar royalties will return to NPS.
NPS is confident in the validity of these patents and will fully support Amgen to protect these patents from infringement.
Sensipar is indicated for the treatment of secondary hyperparathyroidism in chronic kidney disease patients on dialysis and for the treatment of elevated calcium levels (hypercalcemia) in patients with parathyroid carcinoma.[SM]
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