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Last updated on April 19, 2014 at 7:22 EDT

QIAGEN and Pfizer Partner to Develop Companion Diagnostic for Novel Compound in Global Clinical Trials for Lung Cancer

August 16, 2011

GERMANTOWN, Maryland and HILDEN, Germany, August 16, 2011 /PRNewswire/ –

        - Diagnostic-therapeutic combination aims to improve standard
          of care for patients with non-small cell lung cancer (NSCLC)
        - Molecular test for KRAS gene mutations holds potential to help
          determine whether there is a subset of patients who are more likely to
          benefit from Pfizer's investigational anticancer compound
        - Collaboration in lung cancer follows QIAGEN's two FDA
          submissions of KRAS mutation-based companion diagnostics in metastatic
          colorectal cancer treatment
        - Partnership builds on QIAGEN's leadership in Personalized
          Healthcare, with more than 15 co-developments and 20 companion
          diagnostics

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced it
has entered into a partnership with Pfizer Inc. (NYSE: PFE) for the
development of a companion molecular diagnostic test for use with an
investigational Pfizer compound in global clinical development for treatment
of non-small cell lung cancer (NSCLC). Financial terms of the agreement were
not disclosed.

Pfizer’s investigational compound, dacomitinib (PF-00299804), is an oral
inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (human
epidermal growth factor receptor) signaling pathway plays a role in the
complex process of cell growth and metastasis, making it a target for
anti-cancer drugs.

QIAGEN’s proposed companion diagnostic will be based on its proprietary
KRAS assay technology, which reliably detects mutations of the KRAS gene
that are frequently found in human cancers. Because EGFR inhibitors are
generally effective in patients without these KRAS mutations, the QIAGEN
assay can be useful in identifying patients most appropriate for
EGFR-inhibitor therapies. QIAGEN recently submitted the application for
Premarket Approval (PMA) for KRAS companion diagnostics to the FDA for use
with two other, separate drugs targeting metastatic colorectal cancers. The
Pfizer drug companion diagnostic test is being specifically developed for
use in lung cancer tissue. It uses the same core assay component as the
therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow
to allow for lung tissue-specific sample technology in a fully automated
workflow.

QIAGEN and Pfizer will engage in collaborative efforts to develop the
KRAS companion diagnostic for use with dacomitinib (PF-00299804). The global
partnership covers clinical trials and submissions for a PMA application in
the United States and the CE mark in Europe, as well as applicable
regulatory approvals in other regions.

“We are pleased to collaborate with Pfizer seeking to advance
personalized healthcare with a new potential tool in the fight against
non-small cell lung cancer, a major killer around the world,” commented Dr.
Stephen Little, Vice President Personalized Healthcare at QIAGEN. “This
partnership unites QIAGEN’s capabilities in companion diagnostics with
Pfizer’s scientific excellence and global presence to develop an innovative
diagnostic-therapeutic combination with the potential to improve the
standard of care for NSCLC patients.”

Lung cancer is the most common cancer globally in incidence
[http://en.wikipedia.org/wiki/Incidence ] and mortality. About 1.1 million
new cases are reported each year in males, with 0.95 million deaths, and
0.51 million new cases per year are reported in females, with 0.43 million
deaths. Worldwide, approximately 85% of all lung cancers are classified as
non-small cell lung cancer, with a five-year survival rate of only about
15%.

“QIAGEN has invested deeply in Personalized Healthcare as the global
leader in partnering with pharmaceutical companies to create companion
diagnostics. Using genomic information to guide each patient’s treatment is
transforming the practice of medicine,” Dr. Little added. “In addition to
more than 20 tests we already offer commercially, QIAGEN is co-developing
companion diagnostics in more than 15 Pharma partnerships, a dynamic growth
driver for our business.”

Following clinical development of the KRAS companion diagnostic for
NSCLC, QIAGEN expects to submit a premarket approval application supplement
(PMAS) to FDA for full automation of the workflow to allow pathologists easy
access and processing of lung tissue samples.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global
provider of sample and assay technologies. Sample technologies are used to
isolate and process DNA, RNA and proteins from biological samples such as
blood or tissue. Assay technologies are used to make such isolated
bio-molecules visible. QIAGEN has developed and markets more than 500 sample
and assay products as well as automated solutions for such consumables. The
company provides its products to molecular diagnostics laboratories,
academic researchers, pharmaceutical and biotechnology companies, and
applied testing customers for purposes such as forensics, animal or food
testing and pharmaceutical process control. QIAGEN’s assay technologies
include one of the broadest panels of molecular diagnostic tests available
worldwide. This panel includes the digene HPV Test, which is regarded as a
“gold standard” in testing for high-risk types of human papillomavirus
(HPV), the primary cause of cervical cancer, as well as a broad suite of
solutions for infectious disease testing and companion diagnostics. QIAGEN
employs nearly 3,600 people in over 35 locations worldwide. Further
information about QIAGEN can be found at http://www.qiagen.com.

Certain of the statements contained in this news release may be
considered forward-looking statements within the meaning of Section 27A of
the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S.
Securities Exchange Act of 1934, as amended. To the extent that any of the
statements contained herein relating to QIAGEN’s products, markets, strategy
or operating results, including without limitation its expected operating
results, are forward-looking, such statements are based on current
expectations and assumptions that involve a number of uncertainties and
risks. Such uncertainties and risks include, but are not limited to, risks
associated with management of growth and international operations (including
the effects of currency fluctuations, regulatory processes and dependence on
logistics), variability of operating results and allocations between
business segments, the commercial development of markets for our products in
applied testing, personalized healthcare, clinical research, proteomics,
women’s health/HPV testing and nucleic acid-based molecular diagnostics;
changing relationships with customers, suppliers and strategic partners;
competition; rapid or unexpected changes in technologies; fluctuations in
demand for QIAGEN’s products (including fluctuations due to general economic
conditions, the level and timing of customers’ funding, budgets and other
factors); our ability to obtain regulatory approval of our products;
difficulties in successfully adapting QIAGEN’s products to integrated
solutions and producing such products; the ability of QIAGEN to identify and
develop new products and to differentiate and protect our products from
competitors’ products; market acceptance of QIAGEN’s new products and the
integration of acquired technologies and businesses. For further
information, please refer to the discussions in reports that QIAGEN has
filed with, or furnished to, the U.S. Securities and Exchange Commission
(SEC).

        Contacts:

        Public Relations:

        Dr. Thomas Theuringer
        Director Public Relations
        +49-2103-29-11826
        Email: pr@qiagen.com

http://www.twitter.com/qiagen

        Investor Relations:

        John Gilardi
        VP Corporate Communications
        +49-2103-29-11711

        Dr. Solveigh Maehler
        Director Investor Relations
        +49-2103-29-11710
        Email: ir@qiagen.com

SOURCE QIAGEN N.V.


Source: newswire