OPKO Health to Acquire Prost-Data (OURLab), a Profitable CLIA Laboratory with Strong U.S. Presence in Urologic Pathology
October 19 2012 - 8:13AM
Business Wire
OPKO Health, Inc. (NYSE:OPK) has entered into a definitive
agreement to acquire Prost-Data, Inc., doing business as OURLab, a
Nashville-based CLIA laboratory with 18 phlebotomy sites throughout
the U.S. and an experienced national sales force calling primarily
on urologists.
OURLab provides OPKO with a commercial platform to support the
near-term U.S. commercial launch of its novel panel of kallikrein
biomarkers and associated algorithm (4Kscore™) for the detection of
prostate cancer. The OPKO 4Kscore™ is the result of a decade of
research by scientists in Europe and the U.S. and has been
demonstrated in more than 10,000 patients to predict the
probability of positive biopsies in men suspected of having
prostate cancer. Extensive studies have shown that the use of the
4Kscore™ may reduce the number of unnecessary prostate biopsies by
50% or more, avoiding the frequent complications of pain, bleeding,
and infection, which sometimes require hospitalization. The data
indicate that even with the significant reduction in the number of
biopsies performed, the probability of delaying diagnosis of a high
grade cancer was only 0.6%. Men whose 4Kscore™ is low enough to not
lead to biopsies would be followed with active surveillance by the
urologist.
Benefitting from its close proximity to an important U.S.
airport hub, OURLab has been able to provide exceptional customer
service through the efficient delivery of timely and trusted
laboratory results, typically providing test results within 24
hours of a sample being taken. OURLab combines professional
expertise with cutting edge technology to enable physicians to
deliver superior patient care.
“The addition of OURLab to the OPKO family will support the
early launch of the important 4Kscore™ prostate test as a
laboratory-developed test in the U.S. and complements the Company’s
recent European commercial launch of the 4Kscore™ through its
UK-based partner, International Health Technology, as part of its
ProstateCheck™ early prostate cancer detection service,” said
Phillip Frost, M.D., Chairman and CEO of OPKO Health. “OURLab’s
keen focus on exceptional customer service with its experienced
operational team will accelerate the launch of our novel prostate
test while helping clinicians in their overall diagnosis of
prostate cancer. The OURLab structure will also be helpful in
speeding the development and introduction of other important tests,
including newly discovered antibody-based tests which utilize
OPKO’s unique peptoid technology.”
Upon the completion of the OURLab acquisition, Dr. Jonathan
Oppenheimer, OURLab’s founder and Chief Executive Officer, will
assume the role of Chief Executive Officer of OPKO’s diagnostics
division. “OURLab anticipates that OPKO’s superior resources and
novel technologies will facilitate greater penetration into other
medical subspecialties and give its sales force unique products to
serve its growing physician and laboratory clientele. The 4Kscore™
is a prime example of a timely medical test satisfying a clear
unmet need,” commented Dr. Oppenheimer.
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.
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 the
benefits and synergies resulting from the acquisition of OURLab,
including whether OURLab will provide a commercial platform that
supports the near-term launch of OPKO’s 4Kscore™ in the United
States, the timing for the launch of the OPKO 4Kscore™, the
potential benefits of the OPKO 4Kscore™, the ability to predict,
reduce, or eliminate the need for biopsies, whether OPKO or OURLab
will be able to successfully commercialize the OPKO 4Kscore™,
whether the product will provide an opportunity to identify high
grade cancers and focus clinical interventions on these, the
probability rate for delaying diagnosis of a high grade cancer,
whether the biomarkers will offer higher specificity or greater
accuracy than current diagnostics or provide clinicians with a
differentiated critical component in their overall diagnosis of
prostate cancer while providing patients with better and more
efficient healthcare, the ability to speed the development and
introduction of other important tests, including newly-discovered
antibody-based tests which utilize OPKO’s unique peptoid
technology, and whether OPKO and OURLab will be able to facilitate
greater penetration in other medical subspecialties, 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, that the various
conditions to the closing of the transaction with OURLab may not be
met, as well as 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.
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