Amgen's Sensipar (cinacalcet) will cost $8.10 per 30 mg tablet, Amgen says.

The drug, Amgen's first small molecule product, is also available in 60 mg and 90 mg tablets, which will be priced on a linear scale, the company announced during its R&D day March 23.

Sensipar was approved March 8 for the treatment of secondary hyperparathyroidism in chronic kidney disease patients on dialysis and hypercalcemia associated with parathyroid carcinoma (¹ Also see "Amgen Sensipar Clears FDA: Phosphate Binders Are A Competitive Target" - Pink Sheet, 15 March, 2004., p. 23).

The average dose, between 50 and 60 mg a day, "turns out to be a premium over [Genzyme's phosphate binder] Renagel and vitamin D, but we really don't see ourselves competing directly against them necessarily," VP-Global Commercial Operations George Morrow said. "We think this is a major advance."

"It's a significant advance and we think it's a fair price," he added.

Amgen expects that Sensipar will move 40% of patients into the target range of biochemical parameters versus the current success rate of 8%.

The drug is "approvable" for chronic kidney disease patients not on dialysis and for primary hyperparathyroidism (² Also see "Sensipar Hypocalcemia Studies Are Key To Expanded Indication, Amgen Says" - Pink Sheet, 15 March, 2004., p. 24).

FDA is looking to understand what the risk of hypocalcemia is and at what interval patients should be monitored to minimize the risk.

"We will be pursuing those studies. It's actually not very challenging to do because we've spent a lot of time in this area. This is a patient population and a disease that we understand very well," VP-Research & Development Roger Perlmutter, MD/PhD, said.

Sensipar Is $8.10 Per 30 Mg; “Fair Price” For “Major Advance,” Amgen Says

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