Amgen (AMGN) recently reported disappointing results on Sensipar (EU trade name: Mimpara) from a phase III study – EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE).
The study was conducted to evaluate Sensipar’s efficacy and safety in the reduction of the risk of all-cause mortality and cardiovascular (CV) events in patients with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) receiving dialysis.
The international, randomized, double-blind, placebo-controlled study failed to meet its primary endpoint. While patients on Sensipar experienced a lower number of composite primary events, statistical significance was not achieved.
Amgen said that Sensipar’s safety profile was similar to the product’s known safety profile. Detailed results will be available later this year.
Sensipar is currently approved in more than 50 countries for the treatment of SHPT in CKD patients receiving dialysis. It is also approved in the US, EU and Canada for hypercalcemia in patients with parathyroid carcinoma and severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy.
Sensipar global sales came in at $808 million in 2011.
Amgen has been working on expanding the life-cycle of its nephrology franchise. Earlier this year, the company announced its intention to acquire privately-held pharma company, KAI Pharmaceuticals. With this acquisition, Amgen will gain global rights (excluding Japan) to KAI Pharmaceuticals’ lead pipeline candidate, KAI-4169, which is being evaluated for the treatment of SHPT in CKD patients on dialysis.
By developing KAI-4169, Amgen is most likely looking to maintain its share in the CKD market once Sensipar loses patent protection. KAI-4169 could represent a different and convenient treatment option for patients as it is being developed as an intravenous (IV) formulation that will be administered at the time of dialysis while Sensipar is a tablet. However, KAI-4169 is yet to enter phase III development and is still a few years from commercialization.
We currently have a Neutral recommendation on Amgen, which carries a Zacks #3 Rank (short-term ‘Hold’ rating).
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