Aeterna Zentaris Expands Promotion of APIFINY® into Florida
08 August 2016 - 10:30PM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”)
today announced that it is expanding its promotion of APIFINY®, the
only cancer-specific, non-PSA blood test available to assess the
risk for the presence of prostate cancer, into the important
Florida market pursuant to its exclusive promotional agreement with
Armune BioScience, Inc. (“Armune”), the owner of the product. The
expansion into Florida follows Armune’s receipt of a clinical
laboratory license from the State of Florida.
“Our sales and marketing teams are well positioned to leverage
the opportunity in the Florida market. We believe APIFINY® provides
significant value in aiding clinicians to more accurately determine
the optimal clinical pathway for men at risk of prostate cancer by
means of its non-PSA based measurement of risk for the presence of
prostate cancer. APIFINY® helps meet the needs of achieving value
in today’s shifting healthcare environment that involves improving
outcomes and patient experiences while lowering overall costs,”
commented Jude Dinges, Chief Commercial Officer of the Company.
“We are excited to enter the Florida market with the recent
approval of our laboratory license by the State of Florida,” said
David Esposito, President and Chief Executive Officer of Armune.
“With over 7,000 tests ordered since the launch of APIFINY®, we
anticipate significant demand being generated from the Florida
market. Given the current concerns of PSA testing throughout the
world, APIFINY® is well positioned to offer clinicians additional
information in the assessment of prostate cancer risk. In addition,
we are confident that APIFINY® will help to address our healthcare
system’s demand for improved outcomes at lower costs.”
About Prostate Cancer
Other than skin cancer, prostate cancer is the most common
cancer in American men. The American Cancer Society predicted that
220,800 new cases of prostate cancer in the United States would
occur in 2015, that there would be 27,540 prostate cancer deaths
during the year and that one man in seven would be diagnosed with
prostate cancer during his lifetime. Approximately 60% of prostate
cancer is diagnosed in men aged 65 or older, and it is rare before
age 40. Prostate cancer is the second leading cause of cancer death
in American men, behind only lung cancer. Prostate cancer can be a
serious disease, but most men diagnosed with prostate cancer do not
die from it. In fact, more than 2.9 million men in the United
States who have been diagnosed with prostate cancer at some point
are still alive today.
About APIFINY®
APIFINY® is the only cancer-specific, non-PSA blood test that
may aid clinicians in the assessment of risk for the presence of
prostate cancer. APIFINY® technology measures specific biological
markers known to be associated with the immune system’s response to
prostate cancer and is based on the measurement of eight
prostate-cancer-specific autoantibodies in human serum. These
autoantibodies are produced and amplified by the immune system in
response to the presence of prostate cancer cells. The
autoantibodies are stable and, because of their amplification, are
likely to be abundant and easy to detect, especially with small
tumors characteristic of early-stage cancers. The autoantibody
markers span a range of biological functions integral to prostate
cancer progression. APIFINY® is offered as a lab developed test by
Armune BioScience in its CLIA regulated laboratory located in Ann
Arbor, MI.
About Armune BioScience
Armune is a medical diagnostics company that develops and
commercializes unique proprietary technology exclusively licensed
from the University of Michigan for diagnostic and prognostic tests
for cancer. The Armune BioScience Laboratory is a commercial
reference laboratory, certified and regulated by the federal
Clinical Laboratory Improvement Amendments (CLIA) law established
in 1988. The laboratory’s CLIA Certificate permits it to perform
APIFINY® and other high-complexity medical tests. Armune, a private
company, has a corporate headquarters in Kalamazoo, MI and a
research and commercial laboratory in Ann Arbor, MI. For more
information, visit www.armune.com.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women’s health. We are engaged in drug
development activities and in the promotion of products for others.
We are now conducting Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition of licenses to products that are relevant to our
therapeutic areas of focus. We also intend to license out certain
commercial rights of internally developed products to licensees in
territories where such out-licensing would enable us to ensure
development, registration and launch of our product candidates. Our
goal is to become a growth-oriented specialty biopharmaceutical
company by pursuing successful development and commercialization of
our product portfolio, achieving successful commercial presence and
growth, while consistently delivering value to our shareholders,
employees and the medical providers and patients who will benefit
from our products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US Securities
Litigation Reform Act of 1995. Forward-looking statements may
include, but are not limited to statements preceded by, followed
by, or that include the words “expects,” “believes,” “intends,”
“anticipates,” and similar terms that relate to future events,
performance, or our results. Forward-looking statements involve
known and unknown risks and uncertainties that could cause the
Company’s actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects and clinical trials, the successful and timely
completion of clinical studies, the risk that safety and efficacy
data from any of our Phase 3 trials may not coincide with the data
analyses from previously reported Phase 1 and/or Phase 2 clinical
trials, the rejection or non-acceptance of any new drug application
by one or more regulatory authorities and, more generally,
uncertainties related to the regulatory process, the ability of the
Company to efficiently commercialize one or more of its products or
product candidates, the degree of market acceptance once our
products are approved for commercialization, the ability of the
Company to take advantage of business opportunities in the
pharmaceutical industry, the ability to protect our intellectual
property, the potential of liability arising from shareholder
lawsuits and general changes in economic conditions. Investors
should consult the Company's quarterly and annual filings with the
Canadian and US securities commissions for additional information
on risks and uncertainties relating to forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements. The Company does not undertake to
update these forward-looking statements. We disclaim any obligation
to update any such factors or to publicly announce the result of
any revisions to any of the forward-looking statements contained
herein to reflect future results, events or developments, except if
required to do so.
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Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
Presidentir@aezsinc.com
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