Somatrogon Phase 3 Pediatric Trial Results will be presented on June 8 at ENDO Online 2020
April 22 2020 - 8:00AM
OPKO Health, Inc. (NASDAQ: OPK) today
provided an update on two abstracts regarding the global Phase 3
somatrogon pediatric trial evaluating somatrogon dosed once weekly
in pre-pubertal children with growth hormone deficiency
(GHD). The data from the two abstracts, which were previously
accepted for oral presentation at the Endocrine Society’s (ENDO)
2020 meeting, will now be combined into a single presentation at
ENDO Online 2020, a virtual event being held June 8 through 22 that
will feature on-demand and live programming. The virtual event will
incorporate select content from the ENDO 2020 meeting previously
scheduled for March 29 through 30 in San Francisco, which was
cancelled due to the COVID-19 outbreak.
The results of the pivotal Phase 3 study will be delivered on
June 8, 2020 at 11:00 a.m. Eastern time by Dr. Cheri Deal, the
Principal Investigator of the Pediatric study. The
presentation will be available to those registered for ENDO Online
2020.
The two abstracts entitled “Somatrogon Growth Hormone in the
Treatment of Pediatric Growth Hormone Deficiency: Results of
the Pivotal Phase 3” and “Interpretation of Insulin-like Growth
Factor (IGF-1) Levels Following Administration of Somatrogon (a
long-acting Growth Hormone-hGH-CTP)” will be published online in
the April-May supplemental issue of the Journal of Endocrinology
Society.
On October 21, 2019, OPKO Health and Pfizer Inc. announced that
the global Phase 3 trial met its primary endpoint of
non-inferiority to daily GENOTROPIN® (somatropin) for injection, as
measured by annual height velocity at 12 months.
In 2014, Pfizer and OPKO entered into a worldwide agreement for
the development and commercialization of somatrogon for the
treatment of GHD. Under the agreement, OPKO is responsible for
conducting the clinical program and Pfizer is responsible for
registering and commercializing the product.
About OPKO Health, Inc.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 www.opko.com.
Cautionary Statement Regarding Forward-Looking
StatementsThis 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 non-historical
statements about our expectations, beliefs or intentions regarding
our business, technologies and products, financial condition,
strategies or prospects, as well as statements about expected
benefits of hGH-CTP. 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 the OPKO Health, Inc. Annual Reports on Form
10-K filed and to be filed with the Securities and Exchange
Commission and in its other filings with the Securities and
Exchange Commission. 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:
LHA Investor RelationsYvonne Briggs,
310-691-7100ybriggs@lhai.com orBruce Voss,
310-691-7100bvoss@lhai.com
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