OPKO Spain to Start Trial of Once-A-Year Intra-Articular Injectable for Osteoarthritis
February 08 2017 - 8:00AM
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 SpainOPKO 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.
Contacts:
OPKO Health, Inc.
David Malina, 305-575-4137Investor Relations
or
Media
Rooney & Associates
Terry Rooney, 212-223-0689trooney@rooneyco.com
or
Marion Janic, 212-223-4017mjanic@rooneyco.com
or
Investors
LHA
Anne Marie Fields, 212-838-3777afields@lhai.com
or
Bruce Voss, 310-691-7100bvoss@lhai.com
Source: OPKO Health Inc.
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