September 06, 2016 8:30am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NASDAQ:OPK) will present abstracts at the 55 th
Annual Meeting of the European Society for Paediatric Endocrinology
(ESPE) to be held in Paris, France on September 10-12, 2016.
Twenty four month phase 2 efficacy, safety, pharmacokinetic, and
pharmacodynamic data from OPKO’s long acting human growth hormone,
hGH-CTP, in growth hormone deficient children will be presented.
OPKO will also hold a workshop for participating endocrinologists to
review final phase 3 study plans.
OPKO expects to shortly initiate a global pivotal phase 3 study in
pre-pubertal growth hormone deficient children to evaluate weekly single
doses of hGH-CTP versus daily injections of a presently used growth
hormone product. OPKO has a world-wide collaboration agreement with
Pfizer Inc. for the development and commercialization of hGH-CTP.
Oral Presentations
Date
Batch-to-Batch Consistency of a Highly O-Glycosylated Long-Acting
Human Growth Hormone (MOD-4023)
Session name: Growth: Clinical
Date: September 12,
Session time: 09:15 - 10:45 am CEST
ESPE
Abstracts (2016) 86 RFC8.3
Efficacy of Once-Weekly Administration of CTP-Modified Human
Growth Hormone (MOD-4023): 24-Month Complete Database Results of a
Phase 2 Study in Children with Growth Hormone Deficiency
Abstracts (2016) 86 RFC8.8
Safety and Tolerability of Once-Weekly Administration of
CTP-Modified Human Growth Hormone (MOD-4023): 24-month Complete
Dataset Results of a Phase 2 Study in Children with Growth Hormone
Deficiency
Session time: 9:15- 10:45 am CEST
ESPE
Abstracts (2016) 86 RFC8.7
Optimal Sampling of IGF-1 During Weekly Administration of a Long
Acting Human Growth Hormone (MOD 4023)
Abstracts (2016) 86 RFC8.5
2 nd Year Pharmacokinetic and Pharmacodynamic
Modeling of Long Acting Human Growth Hormone (MOD-4023) in Growth
Hormone Deficient Children: ESPE
Abstracts (2016) 86 P-P1-625
Immunogenicity Results of Once-Weekly Administration of CTP-Modified
Human Growth Hormone (MOD-4023): A Phase 2 Study in Children with Growth
Hormone Deficiency: ESPE
Abstracts (2016) 86 P-P1-615
About hGH-CTP
hGH-CTP is a novel, long acting recombinant human growth hormone analog
being developed by OPKO for the treatment of children with growth
failure due to inadequate growth hormone secretion, and adults with
growth hormone deficiency.
OPKO's proprietary technology prolongs a therapeutic protein's half life
without the use of polymers, encapsulation techniques, or nanoparticles.
This technology uses a natural peptide, the C-terminal peptide (CTP) of
the beta chain of human chorionic gonadotropin (hCG). hGH-CTP has been
granted orphan drug designation in the U.S. and Europe for both adults
and children with growth hormone deficiency.
About OPKO Health
OPKO Health, Inc. 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
third-largest clinical laboratory in the U.S. with a core genetic
testing business and a 420 person sales force to drive growth and sell
new products, such as the 4Kscore prostate cancer test and the Claros 1
in office immunoassay platform. Our pharmaceutical business features
RAYALDEE, an FDA approved treatment for stage 3-4 CKD patients with
secondary hyperparathyroidism and vitamin D insufficiency, and VARUBI™
for chemotherapy-induced nausea and vomiting (oral formulation launched
by partner Tesaro and IV formulation PDUFA is January 2017). Our
biologics products under development are hGH-CTP, a once weekly human
growth hormone for injection (partnered with Pfizer), long acting Factor
VIIa for hemophilia (in Phase 2a) and a long acting oxyntomodulin for
diabetes and obesity (in Phase 1). OPKO has production and distribution
assets in several countries abroad, 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 timing of study completion, OPKO’s ability
to commence its phase 3 pediatric study for hGH-CTP later this year,
whether OPKO's clinical trials for hGH-CTP in adult and pediatric growth
hormone deficiency will be successful or generate data to support
marketing approval, whether study results will demonstrate hGH-CTP is
non-inferior compared to daily hGH, whether it will prove to be safe and
effective, 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, litigation, and the success of
our collaboration on hGH-CTP with Pfizer, Inc. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160906005436/en/
OPKO Health, Inc.
Investor Relations, 305-575-4100
or
Media
Rooney & Associates
Terry
Rooney, 212-223-0689
or
Rooney
& Associates
Marion Janic, 212-223-4017
Source: OPKO Health, Inc.
Released September 6, 2016
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