- hGH-CTP in global clinical
development for the treatment of pediatric and adult growth hormone
deficiency (GHD)
- hGH-CTP has potential to reduce
dosing frequency of human growth hormone to single weekly injection
from current standard of daily injection
- OPKO to receive upfront payment of
$295 million and eligible to receive up to an additional $275
million upon achievement of regulatory milestones
- Upon Pfizer’s commercialization of
hGH-CTP, OPKO is eligible to receive royalty and/or profit sharing
payments
- Pfizer to obtain exclusive license
to commercialize hGH-CTP globally
OPKO Health, Inc. (NYSE:OPK) and Pfizer Inc. (NYSE:PFE)
announced today that they have entered into a worldwide agreement
for the development and commercialization of OPKO’s long-acting
hGH-CTP for the treatment of growth hormone deficiency (GHD) in
adults and children, as well as for the treatment of growth failure
in children born small for gestational age (SGA) who fail to show
catch-up growth by 2 years of age. hGH-CTP has the potential to
reduce the required dosing frequency of human growth hormone to a
single weekly injection from the current standard of one injection
per day. hGH-CTP is currently in a global phase 3 trial in adults
and a global phase 2 trial in children and has orphan drug
designation in the U.S. and Europe for both adults and children
with GHD.
Under the terms of the agreement, OPKO will receive an upfront
payment of $295 million and is eligible to receive up to an
additional $275 million upon the achievement of certain regulatory
milestones. Pfizer will receive the exclusive license to
commercialize hGH-CTP worldwide.
In addition, OPKO is eligible to receive initial royalty
payments associated with the commercialization of hGH-CTP for Adult
GHD which is subject to regulatory approval. Upon the launch of
hGH-CTP for Pediatric GHD, which is subject to regulatory approval,
the royalties will transition to gross profit sharing for both
hGH-CTP and Pfizer’s Genotropin.
OPKO will lead the clinical activities and will be responsible
for funding the development programs for the key indications, which
includes Adult and Pediatric GHD and Pediatric SGA. Pfizer will be
responsible for all development costs for additional indications as
well as all post-marketing studies. In addition, Pfizer will fund
the commercialization activities for all indications and lead the
manufacturing activities covered by the global development
plan.
"We believe this collaboration will help advance our commitments
to patients with Adult and Pediatric Growth Hormone Deficiency as
we believe Pfizer’s strengths, expertise and presence in the human
growth hormone space makes them the ideal partner for our hGH-CTP
program. Our collaboration enables full alignment between Pfizer
and OPKO to optimize development and potentially bring an
innovative treatment to patients. We believe that the global growth
hormone market is currently valued at more than $3 billion, and
believe that hGH-CTP has the potential to be the best in class
long-acting growth hormone product. Our long acting human growth
hormone is our most advanced product candidate utilizing our CTP
technology to extend the half-life of a broad range of therapeutic
peptides and proteins. By reducing the number of injections,
our technology can improve patient compliance,” said OPKO's
CEO, Phillip Frost, M.D.
“This agreement strengthens Pfizer’s commitment to rare
diseases, and we are pleased to work with OPKO to help provide a
potential next-generation therapy for patients with Adult and
Pediatric Growth Hormone Deficiency,” said Geno Germano, group
president, Pfizer Global Innovative Pharma (GIP). “Long-acting
growth hormone is the first innovation in the GHD space in 20
years. hGH-CTP would be complementary to our existing Genotropin
franchise, and could potentially provide an option that could
improve patients’ adherence to treatment with once weekly
dosing.”
The transaction is subject to customary Hart-Scott-Rodino
approval and is expected to close during the first-quarter of
2015.
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 by requiring only
weekly injections potentially improving compliance and treatment
outcomes. OPKO’s proprietary technology allows the company to
extend the hormone’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). OPKO has an
ongoing pivotal Phase 3 clinical trial in adults for hGH-CTP and a
Phase 2 clinical trial in pediatric patients. 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 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.
Pfizer and Rare Diseases
Rare diseases are among the most serious of all illnesses and
impact millions of patients worldwide, representing an opportunity
to apply our knowledge and expertise to help make a significant
impact in addressing unmet medical needs. The Pfizer focus on rare
diseases builds on more than a decade of experience and a global
portfolio of 22 medicines approved worldwide that treat rare
diseases in the areas of hematology, neuroscience, inherited
metabolic disorders, pulmonology, and oncology.
About Pfizer Inc.
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines
as well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us at
www.pfizer.com.
OPKO 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 the collaboration with Pfizer will be successful, whether
OPKO's clinical trials for adult and pediatric growth hormone
deficiency will support marketing approval, whether hGH-CTP will be
successfully developed or commercialized, expectations regarding
the product, its efficacy, safety and market potential, whether
OPKO will receive royalty and/or profit sharing payments for sales
from hGH-CTP, expectations about the global growth hormone market,
whether hGH-CTP has the potential to be the best in class
long-acting growth hormone product, 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.
PFIZER DISCLOSURE NOTICE: The information contained
in this release is as of December 15, 2014. Pfizer assumes no
obligation to update forward-looking statements contained in this
release as the result of new information or future events or
developments.
This release contains forward-looking information about an
agreement between Pfizer and OPKO for the development and
commercialization of hGH-CTP that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Forward-looking
statements include, among other things, those regarding hGH-CTP and
the collaboration, including their potential benefits and market
potential, as well as those about the anticipated timing of the
closing of the transaction. Risks and uncertainties include, among
other things, the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
study commencement and completion dates as well as the possibility
of unfavorable study results; whether and when biologics license
applications may be filed in any jurisdictions for hGH-CTP for any
indication; whether and when any such applications may be approved
by regulatory authorities, which will depend on the assessment by
such regulatory authorities of the benefit-risk profile suggested
by the totality of the efficacy and safety information submitted;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of hGH-CTP in any such indications; risks relating to the
satisfaction of conditions to closing the transaction in the
anticipated timeframe or at all; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2013 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information That May Affect Future Results”, as
well as in its subsequent reports on Form 8-K, all of which are
filed with the SEC and available at www.sec.gov and
www.pfizer.com.
Pfizer Inc.Media:Joan Campion+1.212.733.2798 (O)+1.201.761.9384
(M)Joan.Campion@pfizer.comInvestor:Ryan Crowe+1.212.733.8160
(O)+1.215.260.0914 (M)Ryan.Crowe@pfizer.com
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