2014 Press/Media Releases:

OPKO Health Announces Key Executive Appointments for Renal Division

• Scott Toner Joins as Vice President, US Marketing and Sales
• Stephen A. Strugnell Joins as Senior Director, Scientific Affairs

MIAMI, April 3, 2014 ---- MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK) today announced the hiring of key executives for its Renal Division. Scott Toner will join as Vice President, US Marketing and Sales and Dr. Steve Strugnell will join as Senior Director, Scientific Affairs.

Mr. Toner has over 30 years of pharmaceutical experience with a history of developing effective marketing strategies for new drugs to treat chronic kidney disease (CKD). Mr. Toner was previously Senior Director of Global Marketing at Reata Pharmaceuticals with responsibility for the marketing strategy supporting a new innovative therapy for CKD in type 2 diabetes patients; Executive Director of Marketing at AMAG Pharmaceuticals where he led the launch of Feraheme®, an iron replacement product for dialysis patients; and Director of Renal Commercial Development at Abbott Laboratories with responsibility for Zemplar®. Zemplar became the most successful vitamin D therapy for secondary hyperparathyroidism (SHPT) in the US. Mr. Toner also serves as a member of the Board of the American Association of Kidney Disease Patients (AAKP).

Dr. Strugnell has extensive experience in the research and development of new vitamin D drugs for CKD patients with vitamin D insufficiency. Prior to OPKO, he was Associate Scientific Director at Genzyme Renal and Associate Director of Preclinical Research at Bone Care International where he managed research supporting Hectorol®, the first modern vitamin D product approved in the US for SHPT in pre-dialysis patients. Dr. Strugnell received his PhD degree from Queens University under the direction of Dr. Glenville Jones, and completed a post-doctoral fellowship at the University of Wisconsin-Madison under the direction of Dr. Hector DeLuca. Drs. Jones and DeLuca are internationally regarded experts on vitamin D metabolism.

"Scott and Steve are powerful additions to our management team," said Dr. Charles W. Bishop, CEO of OPKO Renal. "These two individuals have a remarkable understanding of the renal market and provide unparalleled experience in developing and launching proprietary renal disease products."

"The hiring of Scott as Vice President, Marketing and Sales and Steve as Senior Director, Scientific Affairs is an important milestone as we continue to develop our pipeline of renal products and prepare for the commercial launch of Rayaldee™ to treat CKD patients," said Phillip Frost, M.D., Chairman and CEO of OPKO. "We are pleased to welcome Scott and Steve."

About Rayaldee™
Rayaldee is a first-in-class oral vitamin D prohormone treatment being developed for SHPT in stage 3 and 4 CKD patients with vitamin D insufficiency. It has a proprietary modified-release formulation designed to gradually and reliably raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) while avoiding upregulation of CYP24, a cytochrome P-450 enzyme that reduces the parathyroid hormone (PTH) lowering potency of current vitamin D supplements. Activation of calcifediol, the active ingredient in Rayaldee, by the kidney is tightly regulated, preventing excessive elevation of serum calcium and related side effects which encumber current vitamin D hormone therapies and promote vascular and renal calcification. Once approved, Rayaldee is expected to address the approximately 4 million CKD stage 3 and 4 patients in the US and many more, elsewhere, with SHPT and vitamin D insufficiency.

About Chronic Kidney Disease
CKD is a condition characterized by a progressive decline in kidney 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 different stages — mild (stage 1) to severe (stage 5) disease — as measured by the kidney's 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 moderate (stages 3 and 4) and severe (stage 5) forms of CKD. In stage 5 CKD, kidney function is minimal to absent and patients require regular dialysis or a kidney transplant for survival.

About Vitamin D Insufficiency
Vitamin D insufficiency is a condition in which the body has low vitamin D stores, characterized by inadequate blood levels of vitamin D prohormone, known as 25-hydroxyvitamin D. An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases.

About Secondary Hyperparathyroidism (SHPT)
SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of PTH. SHPT arises as a result of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormone to properly regulate calcium and phosphorus metabolism, and PTH secretion. Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus, softening of the bones (osteomalacia) and calcification of vascular and renal tissues. SHPT affects 40-60% of patients with moderate CKD and approximately 90% of patients with severe CKD.

About OPKO
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.

OPKO Health, Inc.
Steven D. Rubin or Juan F. Rodriguez, 305-575-4100
Source: OPKO Health, Inc.

 
     
     
 
   

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