2018 Press/Media Releases:

OPKO Partner Vifor Fresenius Receives Marketing Approval for RAYALDEE in Canada

MIAMI, July 16, 2018 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announced today that the Company's partner Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has received approval from Health Canada to market RAYALDEE® in Canada for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

"We established a global development and commercialization plan for RAYALDEE as this therapy addresses an important medical need in CKD patients worldwide, and we want to ensure that as many people as possible have access to its benefits," stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO Health. "We congratulate our partner Vifor Fresenius on their achievement and thank them for the dedication and hard work they put into reaching this milestone event."

RAYALDEE is an extended-release prohormone of calcitriol, the active form of vitamin D . The product is the first and only such therapy approved by the U.S. Food and Drug Administration (FDA) that both raises serum 25-hydroxyvitamin D and lowers blood levels of intact parathyroid hormone. RAYALDEE is indicated in the U.S. for the treatment of SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency. It is not indicated in patients with stage 5 CKD or end stage renal disease on dialysis.

OPKO Health launched RAYALDEE in the U.S. in November 2016.

About OPKO Health, Inc.
OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes BioReference Laboratories, the nation's third largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, OPK88003, a once- or twice-weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator) for treating BPH (Benign Prostatic Hypertrophy), OPK88002, an NK-1 antagonist to treat pruritus (itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet syndrome. In addition, the Company is advancing its CTP technology, which includes a long-acting hGH-CTP, a once-weekly human growth hormone injection (in Phase 3 and partnered with Pfizer). OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com.

LHA Investor Relations
Miriam Weber Miller, 212-838-3777
Bruce Voss, 310-691-7100


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