OPKO Spain to Start Trial of Once-A-Year Intra-Articular Injectable for Osteoarthritis
MIAMI, Feb. 08, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that its wholly owned subsidiary, OPKO Health Spain, has completed development of Enko 1, a patented intra-articular injectable hyaluronic acid and chondroitin sulfate complex to relieve pain and improve mobility in patients with degenerative and traumatic changes in the knee and other joints, as occurs in osteoarthritis. Enko 1 will be submitted for approval as a Class III medical device with the goal to market it throughout the European Union. The market for hyaluronic acid for this use is $2 billion globally; and $1 billion in Europe.
OPKO Health Spain believes Enko 1, because of its unique physicochemical characteristics, offers significant advantages such as less frequent injections, as few as one per year.
OPKO Health Spain projects the launch of Enko 1 in Europe in the first half of 2018. Enko 1 is also currently being evaluated for use in companion animals for OPKO Health Spain's animal health business, as well as OPKO's new United States-based Animal Health division.
About OPKO Health Spain
OPKO Health Spain is a Barcelona-based company engaged in the development, manufacturing and sale of a robust line of pharmaceutical, nutraceutical and veterinary products in Europe.
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 Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 420-person sales force 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 PDUFA date: January 2017), TT401, 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, and TT701, an androgen receptor modulator for androgen deficiency indications. Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in phase 3 and partnered with Pfizer), a long-acting Factor VIIa drug for hemophilia (in phase 2a) and a long-acting oxyntomodulin for diabetes and obesity (in phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com.
SAFE HARBOR STATEMENT
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and
other words of similar meaning, including statements regarding expected benefits of Enko 1 and whether it offers significant advantages over other products, the expected global and European market for the product, whether Enko 1 will be approved as a Class III medical device and marketed throughout the European Union, the expected launch date for the product and whether it is useful in treating companion animals, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks
inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
OPKO Health, Inc.
David Malina, 305-575-4137
Rooney & Associates
Terry Rooney, 212-223-0689
Marion Janic, 212-223-4017
Anne Marie Fields, 212-838-3777
Bruce Voss, 310-691-7100
Source: OPKO Health Inc.
Source: OPKO Health Inc.
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