June 19, 2014 1:21pm EDT
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Conference Call and Webcast Scheduled at 8:30 a.m. EDT on June 24,
Data Presented During Poster Session at ICE/ENDO 2014
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK), a multinational biopharmaceutical and
diagnostics company that is developing a novel long-acting human growth
hormone product (hGH-CTP) for the treatment of growth hormone deficiency
(GHD), today announced it will hold a conference call and webcast on
Tuesday, June 24, 2014 at 8:30 a.m. EDT (7:30 a.m. CDT).
During the call, OPKO Biologics management will discuss data from the
company's advanced phase 2 trial of hGH-CTP in growth hormone deficient
pediatric subjects. The pharmacokinetic and pharmacodynamics portion of
the results will also be presented at a poster presentation on the prior
Monday afternoon from 2:00 p.m. to 4:00 p.m. EDT (1:00 p.m. to 3:00 p.m.
CDT) during the International Congress of Endocrinology and Endocrine
Society's Annual Meeting and Expo at the McCormick Place West in
Chicago, IL. The poster is titled “Pharmacokinetics and Pharmacodynamics
Phase 2 Dose Finding Study in Children with GH Deficiency”. An
additional poster titled “Production and Characterization of MOD-4023, a
LONG Acting Growth Hormone and Supporting Clinical and Commercial Drug
Product Supply” will be presented in parallel.
The data to be discussed during the call will include six month height
velocity and safety data from the company’s phase 2 trial, which is a
one year dose finding study administering hGH-CTP to growth hormone
deficient children once a week using daily hGH as a comparator arm.
These data affirmed that a single weekly injection of hGH-CTP has the
potential to replace seven consecutive daily injections of currently
marketed hGH, further validating the optimal dose and dosing regimen for
the upcoming phase 3 trial in pediatric patients. In addition, hGH-CTP
demonstrated a very good safety and tolerability profile in this ongoing
study, with no unexpected adverse events.
Conference Call and Webcast
OPKO will hold a conference call on Tuesday, June 24, 2014 at 8:30 a.m.
EDT (7:30 a.m. CDT). The dial-in numbers are 1-877-407-0789 for domestic
callers and 1-201-689-8562 for international callers. A webcast of the
conference call will be available online from the investor relations
page of the Company's corporate website at www.opko.com .
After the webcast, the call will remain available on the OPKO website, www.opko.com ,
for 30 days.
About hGH-CTP
In June 2013, OPKO initiated a pivotal phase 3 clinical trial in adults
of its proprietary long-acting version of hGH-CTP. hGH-CTP has been
awarded orphan drug designation in the U.S. and Europe for both adults
and children with growth hormone deficiency.
ABOUT OPKO HEALTH
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. For more information,
visit http://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 hGH-CTP,
whether OPKO's clinical trials for adult and pediatric growth hormone
deficiency will generate data to support marketing approval, whether
hGH-CTP will be successfully developed or commercialized, expectations
regarding the product and its market potential, 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.
Investor Relations
FTI
Consulting
Barbara Ryan, 212-850-5679
Managing Director
or
Media
Relations
FTI Consulting
Kimberly Ha, 212-850-5612
Senior
Director
Source: OPKO Health, Inc.
Released June 19, 2014
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