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Amgen's Mimpara disappoints in phase III study

Blow for company’s attempt to extend drug label in chronic kidney disease treatment

A bid by Amgen to extend the label claims for its calcimimetic drug Mimpara is looking less likely to be accepted after disappointing results in a phase III trial.

Mimpara (cinacalcet) - which is sold as Sensipar in North America - failed to meet its primary endpoint of reducing the risk of mortality and cardiovascular events in patients with chronic kidney disease (CKD) receiving dialysis.

The EVOLVE study enrolled 3,883 patients with secondary hyperparathyroidism (HPT) and CKD undergoing dialysis, and compared Mimpara to placebo.

The primary endpoint of the study was time to the composite event comprising all-cause mortality or first non-fatal cardiovascular event, including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event.

While patients on Amgen's drug exhibited fewer composite primary events, the results did not achieve statistical significance.

Mimpara was the first small-molecule drug to come through Amgen's pipeline and was approved in 2004 to treat secondary HPT in patients with end-stage renal disease and elevated calcium levels associated with parathyroid carcinoma.

The product added $808m to Amgen's revenues last year and is one of a crop of newer products that are helping to offset declines in the company's erythropoietin franchise.

A cardiovascular benefit would have heightened demand for Mimpara in the marketplace, although the company said there is plenty of growth potential for the drug within the existing patient population.

The EVOLVE trial sought to understand whether lowering calcium levels with Mimpara in patients on long-term dialysis for CKD could bring down the high rates of mortality and cardiovascular events seen in this population.

The hypothesis under test was that tight management of calcium, phosphorus and parathyroid hormone levels in this setting could reduce inappropriate calcification of soft tissues and in turn reduce arterial stiffness.

Despite the disappointing outcome, "EVOLVE will provide the nephrology community with important information," commented Sean Harper, Amgen's executive vice president of R&D.

Amgen had already acknowledged that the study was something of a gamble. Earlier this year Harper said that even in the absence of benefits regarding cardiovascular risk in EVOLVE, the study should reaffirm the established benefits of cinacalcet.

11th June 2012

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