QIAGEN completes second U.S. submission for companion diagnostic to guide treatment decisions in colorectal cancer
- Food and Drug Administration will review therascreen® KRAS RGQ PCR Kit for use with Erbitux® (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
Germantown, Md., and Hilden, Germany, August 5, 2011 - QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced it has completed its second U.S. submission of the therascreen® KRAS RGQ PCR Kit for use as a companion diagnostic paired with Erbitux® (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.
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 www.qiagen.com
For more information about Erbitux visit 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).