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QIAGEN Completes Second U.S.Submission for Companion Diagnostic to Guide Treatment Decisions in Colorectal Cancer

August 5, 2011

GERMANTOWN, Maryland and HILDEN, Germany, August 5, 2011 /PRNewswire/ –

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        - Food and Drug Administration will review therascreen(R) KRAS
          RGQ PCR Kit for use with Erbitux(R) (cetuximab), a metastatic colorectal
          cancer therapy
        - PMA follows a recent submission for use with another EGFR
          inhibitor drug, also in patients with metastatic colorectal cancer
        - QIAGEN achieves milestones in Personalized Healthcare with
          innovative companion diagnostics; FDA decisions expected in 2012

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced it
has completed its second U.S. submission of the therascreen(R) KRAS RGQ PCR
Kit for use as a companion diagnostic paired with Erbitux(R) (cetuximab), a
leading drug for treatment of patients with metastatic colorectal cancer
(mCRC). Erbitux is marketed in the United States by Bristol-Myers Squibb
Company and Eli Lilly and Company. Merck KGaA has the right to market
Erbitux outside the US and Canada.

QIAGEN submitted a Premarket Approval (PMA) application to the FDA for
use of its innovative assay in determining which patients can be expected to
benefit from Erbitux in treatment of mCRC. The first submission of the KRAS
assay, earlier in July, paired QIAGEN’s molecular test with another drug for
treatment of metastatic colorectal cancer. Both therapies are monoclonal
antibody EGFR inhibitors expected to target a range of cancers. Last year’s
sales of Erbitux were US$820 million, representing an 18 percent increase
over 2009.

The therascreen KRAS assay reliably detects mutations of the KRAS gene,
which are frequently found in human cancers. Because monoclonal antibody
EGFR inhibitors are highly effective in colorectal cancer patients who do
not have these KRAS mutations, the QIAGEN assay enables physicians to
predict which patients are likely to respond and to avoid the costs and
harmful patient side effects of ineffective treatment. About 60 percent of
all colorectal cancer patients have a non-mutated KRAS gene, while about 40
percent of patients show mutations that make their cancers unresponsive to
this class of drugs. According to the National Cancer Institute, over 1
million patients in the U.S. were diagnosed with mCRC in 2010.

“QIAGEN’s Personalized Healthcare franchise achieved a double milestone
with these two separate U.S. submissions. These innovations show important
progress in our strategy to accelerate QIAGEN’s growth in 2012 and beyond.
We are planning to validate the KRAS assay on our QIAsymphony RGQ platform,
and we expect approvals of both PMAs in 2012,” said Peer Schatz, Chief
Executive Officer. “The value of the information generated by our
cutting-edge KRAS technology points to the significant potential of
companion diagnostics, both to improve healthcare for patients and to save
money. Experts have estimated that using KRAS testing in colorectal cancer
patients could save healthcare systems more than $600 million in drug costs
alone.”

“QIAGEN has invested aggressively in Personalized Healthcare and is the
global leader in partnering with pharmaceutical companies to create
companion diagnostics. Our growing portfolio of companion diagnostics covers
over 20 assays positioned as or targeted for use in personalized healthcare.
In addition, QIAGEN is engaged in over 15 co-development partnerships with
pharma. Our deep pipeline of regulated personalized healthcare assays
includes an upcoming U.S. submission in 2012 for an EGFR biomarker test for
use with an anticancer medicine for patients with non-small cell lung
cancer,” Mr. Schatz added. “Using molecular information to guide patients’
treatments is changing the way medicine is practiced. Our leadership in
enabling and accelerating this transformation will continue to be a dynamic
growth driver for QIAGEN.”

QIAGEN’s PMA submissions follow the FDA’s issuance of guidelines for the
co-development and approval of drugs and associated companion diagnostics on
July 14, 2011. The agency encourages the use of personalized medicines that
rely on approved or cleared companion diagnostic devices. Without approval
or clearance, the FDA sees tests as a potential public risk due to lack of
adequate proof of accuracy and of well-controlled manufacturing processes.
The guidelines recommend that in future drug labeling bears a reference to a
type of FDA approved or cleared test so that only an approved or cleared
companion diagnostic could be used to guide treatment decisions. QIAGEN is a
pioneer in developing the PMA approach for the approval of companion
diagnostics such as the KRAS assays.

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 30 locations worldwide. Further
information about QIAGEN can be found at http://www.qiagen.com.

About Erbitux

For more information about Erbitux visit http://www.erbitux.com
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Submisison - BMSLilly\www.erbitux.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:

        Investor Relations
        John Gilardi
        +49 2103 29 11711
        Dr. Solveigh Mahler
        +49-2103-29-11710
        Albert F. Fleury
        +1-301-944-7028
        e-mail: ir@qiagen.com

        Public Relations
        Dr. Thomas Theuringer
        +49-2103-29-11826
        e-mail: pr@qiagen.com
        +1-240-686-7425

SOURCE QIAGEN N.V.


Source: newswire



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