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OPKO Health Completes Acquisition Of Two Phase 3 Products

OPKO Health, Inc. (NYSE:OPK) announced that it has completed the acquisition of Cytochroma Inc. (Markham, Canada). Cytochroma’s lead products include CTAP101 Capsules, a vitamin D prohormone to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, and Fermagate Tablets, a new and potent non-absorbed phosphate binder to treat hyperphosphatemia in CKD patients on chronic hemodialysis.

CTAP101 Capsules have been shown in a phase 2b clinical trial to effectively and safely treat SHPT and the underlying vitamin D insufficiency in pre-dialysis patients. Vitamin D insufficiency arises in CKD due to the abnormal upregulation of CYP24, an enzyme which destroys vitamin D and its metabolites. Studies in CKD patients have demonstrated that currently available over-the-counter and prescription vitamin D products cannot reliably raise blood vitamin D prohormone levels and effectively treat SHPT. CTAP101 Capsules are in phase 3 clinical trials in the United States (US).

The new phosphate binder, Fermagate Tablets, has been shown to be safe and effective in treating hyperphosphatemia in phase 2 and 3 trials in CKD patients undergoing chronic hemodialysis. Hyperphosphatemia contributes to soft tissue mineralization and affects approximately 90% of dialysis patients. Dialysis patients require ongoing phosphate binder treatment to maintain normal serum phosphorus levels. Opko is working with US and European regulatory authorities to finalize the remaining Phase 3 clinical program for Fermagate Tablets.

About Chronic Kidney Disease

CKD is a condition characterized by progressive decline in renal function. The kidney is normally responsible for excreting waste and excess water from the body and for regulating various hormones. CKD is classified in five stages — mild (stage 1) to severe (stage 5) disease — according to glomerular filtration rate. According to the National Kidney Foundation, CKD afflicts over 26 million people in the US, including more than eight million patients with stage 3 or 4 CKD. In stage 5, kidney function is minimal to absent and patients require regular dialysis or a kidney transplant for survival.

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