2017 Press/Media Releases:

OPKO Health Enters into Exclusive Agreement with Japan Tobacco to Develop and Commercialize RAYALDEE® in Japan

OPKO to receive up to $118 million in upfront and milestone payments, plus tiered double-digit
royalties on product sales

MIAMI, Oct. 12, 2017 (GLOBE NEWSWIRE) --OPKO Health, Inc. (NASDAQ:OPK) announced that its subsidiary EirGen Pharma has entered into an exclusive agreement with Japan Tobacco Inc. (JT) for the development and commercialization in Japan of RAYALDEE® for the treatment of secondary hyperparathyroidism (SHPT) in non-dialysis and dialysis patients with chronic kidney disease (CKD).

Under the terms of the agreement, JT will make an upfront payment to OPKO of $6 million with another $6 million payment to be made upon initiation of OPKO's planned phase 2 study of RAYALDEE in U.S. dialysis patients. In addition, OPKO will be eligible to receive up to an additional $31 million in development and regulatory milestones and $75 million in sales based milestones. JT will also pay OPKO tiered, double digit royalties on net product sales. JT will be responsible for all regulatory approvals and commercial activities pertaining to RAYALDEE in Japan. According to JT, an estimated 13.3 million people in Japan have CKD and more than 300,000 are undergoing dialysis, with both patient populations increasing due to the aging population.

"JT, together with its subsidiary Torii Pharmaceuticals, has a strong and growing franchise in hemodialysis and renal diseases, which makes JT an ideal partner to bring RAYALDEE to physicians and patients in Japan," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "We believe JT and Torii's innovative marketing activities and their established network with Japanese nephrologists will accelerate adoption of RAYALDEE in this key market. We are confident this collaboration will substantially expand access to the important clinical benefits of RAYALDEE for Japanese patients with CKD."

RAYALDEE is an extended-release prohormone of calcitriol, the active form of vitamin D3 that 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 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, an FDA approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI® for chemotherapy induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once weekly oxyntomodulin for type 2 diabetes and obesity that is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and OPK88004, a selective androgen receptor modulator being developed for benign prostatic hyperplasia and other urologic and metabolic conditions. Our biologics business includes hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and a long acting Factor VIIa drug for hemophilia in phase 2a. We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com.

Contacts

Company
OPKO Health, Inc.
David Malina, 305-575-4137
DMalina@opko.com
Director of Investor Relations

Investors
LHA Investor Relations
Anne Marie Fields, 212-838-3777
afields@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com

Source: OPKO Health Inc. News Provided by Acquire Media

 
     
     
 
   

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