OPKO Acquires ModeX Therapeutics

Rayaldee®

About Rayaldee®

Rayaldee® (calcifediol) is an extended-release prohormone of the active form of vitamin D3 that both raises 25-hydroxyvitamin D and lowers intact parathyroid hormone (iPTH) levels in patients with stage 3 or 4 CKD. Rayaldee® is under development for adult patients with stage 5 chronic kidney disease (CKD) with SHPT and vitamin D insufficiency who require regular dialysis.

About Chronic Kidney Disease

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 37 million adults with CKD according to the National Kidney Foundation (NFK), 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.

About Secondary Hyperparathyroidism

Patients exhibit a steady decline in blood levels of 1,25-dihydroxyvitamin D (vitamin D hormone) as CKD progresses and kidney function diminishes. The declining level of 1,25-dihyroxyvitamin D is a primary cause of SHPT in these patients. SHPT is characterized by abnormally elevated blood levels of PTH and is associated with parathyroid gland hyperplasia and a constellation of metabolic bone diseases, leading eventually to increased bone fracture rates, soft tissue calcifications, cardiovascular disease, muscle weakness and reduced quality of life. Recent evidence suggests that some, if not all, of these adverse outcomes can be prevented, mitigated or reversed by early diagnosis and proper treatment. SHPT is a common complication of CKD, with rising incidence as CKD progresses.

37M

United States adults afflicted by CKD1

~17M

United States adults suffer from moderate CKD (Stages 3 and 4) to severe CKD (Stage 5)1

~90%

Patients with severe CKD afflicted by SHPT2

Source

1 United States Renal Data System

2 National Kidney Foundation

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