OPKO Presents Clinical Data on its Long-acting Human Growth Hormone (hGH-CTP) in Two Oral Presentations at the 54th Annual Meeting of the European Society for Pediatric Endocrinology (ESPE)

October 07, 2015 9:32am EDT

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MIAMI--(BUSINESS WIRE)--

OPKO Health, Inc. (NYSE: OPK) presented clinical data from its completed

12-month hGH-CTP Phase 2 pediatric growth hormone deficiency clinical

study in two oral presentations at the 54th Annual Meeting of the

European Society for Paediatric Endocrinology on October 3, 2015,

in Barcelona, Spain. The presentations included pharmacokinetic,

pharmacodynamic, safety and efficacy data of OPKO’s hGH-CTP in

comparison to a daily Genotropin® arm.

This phase 2 trial was a one-year dose-finding study in which 53 naïve

growth hormone deficient children received one of three doses of hGH-CTP

once weekly (0.25, 0.48 and 0.66 mg/kg/week) or daily Genotropin® as a

comparator arm (34µg/kg/day). The twelve month data confirmed comparable

response of hGH-CTP to daily Genotropin® as reflected by the twelve

month pharmacodynamic, efficacy and safety profile.

Following hGH-CTP administration, IGF-1 SDS profile was maintained

within the normal range with no accumulation or excessive levels (>

+2SDS) during the 12 months of treatment.

Among patients treated with hGH-CTP, the average annual height velocity

(HV) ranged between 10.5 to 12.5 cm, a comparable response to the daily

hGH arm.

In this study, the safety profile of hGH-CTP was also shown to be

comparable to daily hGH.

Highlights from the top-line analysis include

there were no patient withdrawals from the study;

there were no reports of drug-related serious or unexpected adverse

events;

there were no clinically significant local tolerability issues; and

there were no hGH-CTP neutralizing antibodies.

For all subjects postprandial glucose, insulin and HbA1c (%) levels

remained within the normal range throughout the study.

OPKO has a world-wide collaboration agreement with Pfizer Inc. for the

development and commercialization of hGH-CTP. Based on the promising

phase 2 clinical data, the company confirms its plan to initiate a

global pivotal phase 3 study in pre-pubertal GHD children next year

following supply of the product by Pfizer in a pen device evaluating a

single dose of hGH-CTP versus daily injections of growth hormone.

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 endogenous growth hormone secretion, and

adults with growth hormone deficiency (GHD) of either childhood or

adult-onset etiology. hGH-CTP is intended to reduce the burden of daily

injection therapy.

OPKO's proprietary technology enables elongation of a therapeutic

protein's half-life without the use of polymers, encapsulation

techniques, or nanoparticles. This technology is based on 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 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 timing of study completion and the

commencement date for the phase 3 study, whether OPKO's clinical trials

for adult and pediatric growth hormone deficiency will generate data to

support marketing approval, whether study results will demonstrate

non-inferiority compared to daily hGH, 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/20151007005872/en/

OPKO Health, Inc.

Investor Relations, 305-575-4100

or

Media

Contacts

Rooney & Associates

Terry

Rooney, 212-223-0689

or

Rooney

& Associates

Marion Janic, 212-223-4017

Source: OPKO Health

Released October 7, 2015

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