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Amgen (AMGN - Analyst Report) 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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PHILADELPHIA—The proportion of patients with type 2 diabetes who have uncontrolled hypertension is higher in patients with chronic kidney disease (CKD) than those without CKD, investigators announced at the 72nd Scientific Sessions of the American Diabetes Association.

Robert Stellhorn, MS, Janssen Global Services LLC, Raritan, New Jersey, and associates examined the extent of uncontrolled hypertension in 2,181 type 2 diabetics using data from the National Health and Nutrition Examination Survey (NHANES) study for the years 1999-2008. The NHANES group of studies assesses the health and nutritional status of adults and children in the United States using a combination of interviews and physical examinations.

As hypertension is causally related to the development of CKD, and patients with diabetes have higher rates of hypertension, BP control is recognized as a cornerstone of diabetes care. A prior study using NHANES data from 1999-2008 showed that the percentage of type 2 patients with uncontrolled hypertension ranged from 44.9% to 56.9%. The analysis, however, did not take into account CKD status.

Patients included in the present analysis were at least 25 years old at the time they were diagnosed with type 2 diabetes and had valid serum creatinine test results.

Chronic kidney disease stages were based on the classification system used by the National Kidney Foundation. Uncontrolled hypertension was defined as having either a systolic or diastolic pressure reading above 130/80 mm Hg, respectively.

Overall, 45.2% of patients were identified as having some form of CKD. Results showed that 62.3% of CKD patients had uncontrolled hypertension versus 48.6% of patients without CKD.

Although the current use of antihypertensive medication was higher in type 2 diabetes patients with CKD than those without it, a significantly larger proportion of these patients had uncontrolled hypertension (67.2% vs. 54.4%).
As patients progressed with CKD to a higher stage, the proportion of patients on any antihypertensive increased and antihypertensive monotherapy declined and combination therapy use increased.

The analysis also showed that the proportion of patients with hemoglobin A_1C greater than 7 was higher among patients with CKD irrespective of hypertension status.

The results suggest that additional effort is likely warranted in optimizing blood pressure control  in patients with type 2 diabetes, particularly in those with comorbid CKD, the authors concluded.

Finally, he cited two possible study limitations. First, NHANES data are cross-sectional and do not provide repeated measurements of laboratory values for patients over different time periods. Thus, the determination of estimated glomerular filtration rate (eGFR) and CKD status was based on a single laboratory observation for each patient.

Secondly, the older version of the Modification of Diet in Renal Diseases study formula was used to calculate  eGFR because most of the data were in the study are from a period prior to the change in formula.  As a result, the CKD rates may be slightly underestimated.

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DENVER, Jun 11, 2012 (BUSINESS WIRE) -- DaVita Inc. /quotes/zigman/268700/quotes/nls/dva DVA -0.78% , a leading provider of kidney care services that is committed to improving the quality of life for those diagnosed with chronic kidney disease, today announced that it will host its 2nd Annual DaVita Kidney Rock(TM), a timed 5K run/walk at 8:15 a.m. on Saturday, August 11, at Coors Field. DaVita is hosting the event to create awareness of kidney disease and raise funds to help bring dialysis to developing nations around the globe. Every participant who registers will receive two tickets to a Rockies game as part of registration.

"Kidney disease is a silent epidemic and affects one in 10 of the adults in our Denver community," said Kent Thiry, chairman and CEO of DaVita. "We created the DaVita Kidney Rock as a fun way to raise money to help those most in need as well as to educate people on the risk factors for kidney disease."

The 5K course will travel through the streets of downtown Denver and finish at Coors Field. Following the race, participants will enjoy food and drinks, live music from local bands and the DaVita Blues All-Stars, a kids' zone, a kidney health expo with kidney screenings available at no cost, a costume contest and special appearances by the Rockies mascot, Dinger.

Proceeds from the event will benefit Bridge of Life -- DaVita Medical Missions(TM). Bridge of Life is an independent nonprofit organization committed to helping improve kidney health and saving lives by bringing treatment, education and hope to communities around the world where there is limited access to dialysis.

Registration for the DaVita Kidney Rock until August 10 is $35 for adults, $20 for youth (under 18), and $30 for seniors (60 and over). Race-day registration will be available starting at 7:00 a.m.; registration fees will increase by $5 for those who have not pre-registered. A family four-pack is also available. Each participant of the DaVita Kidney Rock will receive a personal fundraising page, with incentives offered beginning at the $100 level. Participants can register online at www.davitakidneyrock.org .

DaVita and DaVita Kidney Rock are trademarks or registered trademark of DaVita Inc. All other trademarks are the property of their respective owners.

About Bridge of Life

Bridge of Life - DaVita Medical Missions, originally founded by DaVita, is an independent 501(c)(3) nonprofit organization whose mission is to help those in underserved areas around the world receive kidney care not readily available to them. As of May 31, 2012, Bridge of Life has conducted 25 Medical Missions in 7 countries, installed or repaired 124 dialysis machines, trained more than 230 kidney care professionals, and increased the capacity of clinics to provide an estimated 70,928 treatments to approximately 682 additional individuals per year. For more information about the organization, please visit www.bridgeoflifemm.org .

About DaVita

DaVita Inc., a Fortune 500(R) company, is a leading provider of kidney care in the United States, delivering dialysis services to patients with chronic kidney failure and end stage renal disease. DaVita strives to improve patients' quality of life by innovating clinical care, and by offering integrated treatment plans, personalized care teams and convenient health-management services. As of March 31, 2012, DaVita operated or provided administrative services at 1,841 outpatient dialysis centers located in the United States serving approximately 145,000 patients. The company also operated 15 outpatient dialysis centers located in three countries outside the United States. DaVita supports numerous programs dedicated to creating positive, sustainable change in communities around the world. The company's leadership development initiatives and social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu. For more information, please visit www.davita.com .

SOURCE: DaVita Inc.

        
        DaVita Inc. 
        Mollie O'Brien, 303-405-2297 
        Cell: 317-502-7962 
        
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Copyright Business Wire 2012

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