Pfizer Inc. (NYSE: PFE) and DxS (a wholly owned subsidiary of
QIAGEN N.V.) (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today
announced that they have entered into an agreement to develop a
companion diagnostic test kit for PF-04948568 (CDX-110), an
immunotherapy vaccine in development for the treatment of
glioblastoma multiforme (GBM). Financial terms of the diagnostic
agreement have not been disclosed.
On April 16, 2008, Pfizer and Celldex Therapeutics, Inc. entered
into an agreement to grant Pfizer an exclusive worldwide license to
PF-04948568 (CDX-110) which is currently in Phase 2 clinical
development for the treatment of newly diagnosed GBM.
Glioblastoma multiforme is the most common malignant primary
brain tumor in adults and occurs in around 25,000 patients
worldwide each year. Pfizer’s investigational drug PF-04948568
(CDX-110) is a peptide vaccine which targets the tumor-specific
Epidermal Growth Factor Receptor variant III (EGFRvIII), a mutated
form of the epidermal growth factor receptor that is only present
in cancer cells and occurs in 25-40 percent of GBM tumors. The
QIAGEN assay is designed to identify those patients whose tumors
express the EGFRvIII mutation, allowing for the possibility of more
targeted and personalized treatment.
The EGFRvIII companion diagnostic will be developed and
manufactured at QIAGEN’s Center of Excellence for Companion
Diagnostics in Manchester, UK. The diagnostic will be a real-time
PCR assay used to detect EGFRvIII RNA in tumor tissue. The assay is
designed to offer a simple workflow, which supports its clinical
utility in routine mutation testing.
Commenting on this announcement, Dr. Stephen Little, Vice
President Personalized Healthcare, for QIAGEN, said, “We are very
pleased to have signed this agreement with Pfizer, as it is another
important step toward the realization of personalized medicine.
QIAGEN is aligned to deliver companion diagnostics to our
pharmaceutical partners and this deal is further evidence of our
commitment to develop our scientific and operational capabilities
to help select the right patient for the right medicine.”
“We look forward to collaborating with QIAGEN's DxS unit in the
development of this important diagnostic tool that could
potentially help physicians better define the most appropriate
treatment for patients who suffer from glioblastoma multiforme,”
said Garry Nicholson, president and general manager of Pfizer’s
Oncology Business Unit.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options to improve the outlook
for cancer patients worldwide. Our strong pipeline, one of the most
robust in the industry, is studied with precise focus on
identifying and translating the best scientific breakthroughs into
clinical application for patients across a wide range of cancers,
including breast, lung, prostate, sarcoma, melanoma, and various
hematologic cancers. Pfizer Oncology Pfizer Oncology has more than
32 biologics and small molecules in clinical development and more
than 200 clinical trials underway.
By working collaboratively with academic institutions,
individual researchers, cooperative research groups, governments,
and licensing partners, Pfizer Oncology strives to cure or control
cancer with breakthrough medicines, to deliver the right drug for
the right patient at the right time.
About Pfizer Inc: Working together for a healthier
world™
At Pfizer, we apply science and our global resources to improve
health and well-being at every stage of life. We strive to set the
standard for quality, safety and value in the discovery,
development and manufacturing of medicines for people and animals.
Our diversified global health care portfolio includes human and
animal biologic and small molecule medicines and vaccines, as well
as nutritional products and many of the world’s best-known consumer
products. For more than 150 years, Pfizer has worked to
make a difference for all who rely on us. To learn more about
our commitments, please visit us at www.pfizer.com.
About QIAGEN
QIAGEN N.V., a Netherlands holding company and the
leading global provider of sample and assay technologies. The
Company’s products are sold to molecular diagnostics laboratories,
academic researchers, pharmaceutical and biotechnology companies,
and applied testing customers and include one of the broadest
panels of molecular diagnostic tests for prevention, profiling and
personalized healthcare available worldwide.
About QIAGEN and Personalized Healthcare: QIAGEN is a leading
company providing molecular diagnostics to aid doctors and drug
companies in selecting therapies for patients. Working in
partnership with pharmaceutical companies, QIAGEN and it’s wholly
owned subsidiary, DxS supports the development and sales of
targeted cancer therapies by providing biomarkers and companion
diagnostics. The Company has a continually expanding portfolio,
most notably including the TheraScreen® and Pyromark assay lines..
The TheraScreen® range of CE-marked clinical diagnostic kits can
identify genetic tumor mutations that are useful in the
determination of whether a patient may respond to specific cancer
therapies, thus enabling doctors to provide the most beneficial
treatment. The portfolio includes two clinical diagnostic kits,
K-RAS and EGFR.* The TheraScreen: K-RAS Mutation kit is a companion
diagnostic for Vectibix® (Amgen) and Erbitux® (Merck KGaA), two
drugs used for the treatment of colorectal cancer. In addition,
QIAGEN has created a portfolio of personalized healthcare assays
for the PyroMark real time full sequence resolution platform.
For more information on QIAGEN and personalized medicine:
www.qiagen.com.
PFIZER DISCLOSURE NOTICE: The information contained in this
release is as of February 4, 2010. 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 that involves
substantial risks and uncertainties about a product candidate,
PF-04948568 (CDX-110), including its potential benefits, as well as
an agreement between Pfizer and Qiagen to develop a diagnostic test
kit to help select patients who might benefit from such product
candidate. Such risks and uncertainties include, among other
things, the uncertainties inherent in drug research and development
and in the development of diagnostic test kits; decisions by
regulatory authorities regarding whether and when to approve such
diagnostic test kit and any drug applications that may be filed for
such product candidate, as well as their decisions regarding
labeling and other matters that could affect the availability or
commercial potential of such product candidate; 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, 2008 and in its reports on Form 10-Q and Form 8-K.
QIAGEN SAFE HARBOR STATEMENT
Statements contained in this release that are not historical
facts are forward-looking statements, including statements about
our products, markets, strategy and operating results. Such
statements are based on current expectations that involve risks and
uncertainties including, but not limited to, those associated with:
management of growth and international operations (including
currency fluctuations and logistics), variability of our operating
results, commercial development of our markets (including applied
testing, clinical and academic research, proteomics, women's
health/HPV testing, molecular diagnostics, personalized healthcare
and companion diagnostics), our relationships with customers,
suppliers and strategic partners, competition, changes in
technology, fluctuations in demand, regulatory requirements,
identifying, developing and producing integrated products
differentiated from our competitors' products, market acceptance of
our products, and integration of acquired technologies and
businesses. For further information, refer to our filings with the
SEC, including our latest Form 20-F. Information in this release is
as of the date of the release, and we undertake no duty to update
this information unless required by law.
* In the United States, both test kits are available for
research use only. They have not been cleared or approved by
authorities including the United States Food and Drug
Administration or any other regulatory agency in the United States
for human diagnostic or other clinical use, and is not intended and
should not be used for human diagnostic or any other clinical
purposes.
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