CAMBRIDGE, Mass. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY) and one of the world’s
leading biotechnology companies, and Veracyte,
Inc., a molecular diagnostics company pioneering the emerging field
of molecular cytology, today announced a global co-promotion partnership
to provide a comprehensive solution for thyroid patients. The
arrangement will give patients worldwide increased access to an advanced
personalized medicine solution for improved diagnosis of thyroid
nodules, and the potential to significantly reduce the number of
unnecessary thyroidectomies.
“Together, our products offer patients
and physicians a powerful personalized medicine solution for the
diagnosis and treatment of thyroid cancer, addressing an unmet need in
the community and improving patient outcomes.”
Under terms of the agreement, Genzyme will market and promote Veracyte’s
Afirma® Thyroid FNA Analysis, an innovative and novel
approach for improved thyroid nodule diagnosis, in the United States
and, subsequently, in global markets. Financial terms of the deal were
not disclosed.
Thyroid cancer is the fastest-growing cancer in the U.S., with an
estimated 56,460 new cases expected in 2012, according to the American
Cancer Society. An estimated 450,000 thyroid nodule fine needle
aspirations (FNAs) – a minimally invasive procedure to extract
suspicious cells for examination under a microscope – are performed in
the U.S. each year to rule out cancer. Thyroid nodule FNAs are
challenging to interpret, however, producing ambiguous results in up to
30 percent of cases. Current guidelines recommend that most of these
patients undergo thyroid resection for a definitive diagnosis, given
that thyroid cancer is highly treatable. Post-surgical results, however,
show that only 20-30 percent of these patients have cancer.
Veracyte’s novel solution combines expert cytopathology assessment of
thyroid nodule FNA samples, with the company’s Afirma Gene Expression
Classifier used to resolve indeterminate results and thus help patients
with benign nodules avoid unnecessary surgery. Two independent clinical
studies – both part of a large, multicenter, prospective clinical trial
involving academic and community sites – have shown that the Afirma Gene
Expression Classifier can reclassify patients with indeterminate thyroid
FNA results as “benign” with the same degree of accuracy as a benign
cytopathology diagnosis. Veracyte announced recently that its Afirma
Gene Expression Classifier has been granted coverage for Medicare
patients nationwide.
Genzyme is an established leader in endocrinology globally, developing
and marketing Thyrogen® (thyrotropin alfa for injection) for
patients with well-differentiated thyroid cancer. Thyrogen is used as an
adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or
without radioiodine imaging. Thyrogen is also approved in the U.S. and
Europe as an adjunctive treatment for radioiodine ablation of thyroid
tissue remnants in patients who have undergone a near total or total
thyroidectomy for well-differentiated thyroid cancer and who do not have
evidence of metastatic thyroid cancer.
“This partnership is a strong fit for both companies and underscores
Genzyme’s commitment to improving the quality of care for patients with
suspected or diagnosed thyroid cancer,” said Genzyme’s Head of Rare
Diseases, Rogerio Vivaldi, M.D. “Together, our products offer patients
and physicians a powerful personalized medicine solution for the
diagnosis and treatment of thyroid cancer, addressing an unmet need in
the community and improving patient outcomes.”
“We are delighted to join forces with Genzyme,” said Bonnie Anderson,
Veracyte’s Cofounder and CEO. “This powerful partnership will enable us
to utilize Genzyme’s specialized endocrinology sales force and marketing
infrastructure to commercialize our Afirma Thyroid FNA Analysis more
quickly in the U.S. and globally. In addition to benefitting patients,
our solution will improve the cost-effectiveness of thyroid nodule
diagnosis worldwide.”
A recent economic impact study, published in the Journal of Clinical
Endocrinology & Metabolism, concluded that routine use of the
Afirma Gene Expression Classifier in the U.S. would prevent tens of
thousands of avoidable surgeries each year and would provide more than
$600 million in direct medical savings over 5 years.
About Veracyte
Veracyte, Inc., based in South San Francisco, Calif., is pioneering the
emerging field of molecular cytology, applying molecular biomarkers to
cytology samples in order to improve disease diagnosis by clarifying
indeterminate results obtained from current methods. The company aims to
enable doctors to make more informed treatment decisions that improve
patient care and provide cost savings to the healthcare system. The
company utilizes rigorous science and an extensive, multicenter clinical
program throughout discovery and development. Veracyte’s first product –
the Afirma Thyroid FNA Analysis – combines expert cytopathology
assessment with the Afirma Gene Expression Classifier, a genomic test
that clarifies inconclusive thyroid nodule results as benign or
suspicious for cancer. The company is currently in the early biomarker
discovery phase for lung cancer and interstitial lung diseases. Veracyte
is privately held and funded by Domain Associates, Kleiner Perkins
Caufield & Byers, TPG Biotech and Versant Ventures. For more
information, visit www.veracyte.com.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases for
over 30 years. We accomplish our goals through world-class research and
with the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve. That
goal guides and inspires us every day. Genzyme’s portfolio of
transformative therapies, which are marketed in countries around the
world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the reach and resources of
one of the world’s largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme® and Thyrogen® are registered trademarks
of Genzyme Corporation. Veracyte® and Afirma® are
registered trademarks of Veracyte, Inc. All rights reserved.
Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and statements
regarding future performance. Forward-looking statements are generally
identified by the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug,
device or biological application that may be filed for any such product
candidates as well as their decisions regarding labeling and other
matters that could affect the availability or commercial potential of
such products candidates, the absence of guarantee that the products
candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, the Group’s
ability to benefit from external growth opportunities as well as those
discussed or identified in the public filings with the SEC and the AMF
made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s
annual report on Form 20-F for the year ended December 31, 2010. Other
than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
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