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Rayaldee

Staying in Balance with RAYALDEE®

RAYALDEE® is an extended-release (ER) oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the first and only medicine approved by the U.S. Food and Drug Administration for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). RAYALDEE is approved to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and in 11 European countries.

Addressing SHPT with RAYALDEE®

Therapeutic Area

Nephrology

Indication

SHPT (CKD stages 3 and 4)

Clinical Trial Status

Phase 2 In Progress

Partnerships

Vifor Fresenius Medical Care Renal Pharma

About Chronic Kidney Disease

Chronic Kidney Disease (CKD) is a worldwide public health problem with steadily increasing incidence, prevalence, and cost. Key factors driving CKD in developed countries include aging populations and the current epidemic of obesity and its associated complications of hypertension and adult-onset diabetes.

In the United States, there are currently approximately 31 million adults with CKD according to the US Renal Data Service (USRDS), about 17 million of whom suffer from moderate CKD (stages 3 and 4) to severe CKD (stage 5). Stages 3 and 4 are characterized by progressively decreasing kidney function as measured by glomerular filtration rate. In stage 5, kidney function is minimal to altogether absent, and patients require regular dialysis or kidney transplant for survival. An estimated 71-97% of CKD patients have vitamin D insufficiency, which can lead to secondary hyperparathyroidism (SHPT) and resultant debilitating diseases including bone disease, markedly increased bone fracture rates, pervasive soft tissue calcification, cardiovascular disease, muscle weakness and reduced quality of life.

31M

<p>United States adults afflicted by CKD<sup>1</sup></p>

~17M

<p>United States adults suffer from moderate CKD (Stages 3 and 4) to severe CKD (Stage&nbsp;5)</p>

~90%

<p>Patients with severe CKD afflicted by SHPT<sup>2</sup></p>

In the United States, there are currently approximately 31 million adults with CKD according to the US Renal Data Service (USRDS), about 17 million of whom suffer from moderate CKD (stages 3 and 4) to severe CKD (stage 5). Stages 3 and 4 are characterized by progressively decreasing kidney function as measured by glomerular filtration rate. In stage 5, kidney function is minimal to altogether absent, and patients require regular dialysis or kidney transplant for survival. An estimated 71-97% of CKD patients have vitamin D insufficiency, which can lead to secondary hyperparathyroidism (SHPT) and resultant debilitating diseases including bone disease, markedly increased bone fracture rates, pervasive soft tissue calcification, cardiovascular disease, muscle weakness and reduced quality of life.

Source

1.United States Renal Data System

2.National Kidney Foundation