pan>)--OPKO Health, Inc. (NYSE:OPK)
today announced the acquisition of an exclusive license from Arctic
Partners Ab Oy (Turku, Finland) for two biomarkers in the kallikrein
family which, used together with prostate specific antigen (PSA), can
reduce the need for prostate biopsies by over 50%. These novel
biomarkers were developed by investigators at the University of Malmo,
Sweden, University of Turku, Finland, and Memorial Sloan Kettering
Cancer Center, New York. The research results indicate that these
markers can predict initial biopsy results in men suspected of having
prostate cancer; they have been tested in over 8,000 men and were
independently validated in the European Randomized Study of Prostate
Cancer Screening (Rotterdam).
“These two new biomarkers provide us with a unique opportunity to
greatly improve the value of prostate cancer screening. The higher
specificity of our new panel of markers will provide better and more
efficient outcomes, while lowering overall costs”
The value of PSA testing in men who would otherwise not be screened was
assessed in the European Randomized Study of Prostate Cancer.
Approximately 182,000 men in seven European countries were randomized
for PSA screening or to serve as controls. At a median follow-up of
approximately 9 years, PSA screening was associated with a 20% reduction
in deaths from prostate cancer. Despite this finding, it is noted that
48 men would need to be treated to prevent one death from prostate
cancer.1 While quite specific to the prostate gland, PSA is
not specific for prostate cancer. As a result, in the U.S., an estimated
750,000 men receive unnecessary prostate biopsies annually.2
The OPKO test panel will combine PSA and two novel kallikrein markers to
provide significantly greater accuracy.
These two new biomarkers provide us with a unique opportunity to
greatly improve the value of prostate cancer screening. The higher
specificity of our new panel of markers will provide better and more
efficient outcomes, while lowering overall costs, said Phillip Frost,
M.D., Chairman and CEO of OPKO Health.
As a physician who sees many men with elevated PSA levels, I believe
this novel panel of kallikrein biomarkers will help us to greatly reduce
the number of unnecessary prostate biopsies performed with their
attendant side effects and added costs. The research supporting the
value of this panel is sound, and has been validated in thousands of
patients in different clinical settings, including initial PSA
screening, repeated screenings, and in men with a previous negative
biopsy. I believe this panel of tests will eventually replace PSA
measures alone for the early detection of prostate cancer that needs to
be treated, helping us to avoid dealing with small, indolent cancers
that should be left alone, said Peter Scardino, M.D. (Chief of Surgery,
Memorial Sloan Kettering Cancer Center, New York).
Schroder, FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V,
Kwiatkowski M, Lujan M, Lilja H, Zappa M, et al: Screening and
prostate cancer mortality in a randomized European study. N Engl
J Med 2009, 360(13): 1320-1328.
2Vickers AJ, Cronin AM, Aus G, Pihl CG, Becker C, Petersson
K, Scardino PT, Hugosson J, Lilja H: A panel of kaillikrein markers
can reduce unnecessary biopsy for prostate cancer: data from the
European Randomized Study of Prostate Cancer Screening in Goteborg,
Sweden. BMC Med 2008, 6:19.
About OPKO Health, Inc.
OPKO is a multi-national biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large and rapidly
growing medical 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 potential benefits of the
new biomarkers, the ability of the new biomarkers to predict or reduce
the need for biopsies, whether OPKO will be able to commercialize a
diagnostic product utilizing the new biomarkers, whether the new
biomarkers will offer higher specificity or greater accuracy than
current diagnostics or provide better or lower healthcare costs 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, and 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.
Information Source: Business Wire
