QIAGEN plus four
HILDEN, Germany—QIAGEN has entered into four separate agreements that add multiple biomarkers and manufacturing capability to the company's pipeline of diagnostics for personalized healthcare applications. QIAGEN intends to develop new diagnostics to guide treatment decisions (including companion diagnostics paired with medicines) based on these biomarkers for use in therapeutic areas such as rheumatoid arthritis, lung cancer and colorectal cancer.
Most of these assays will be designed to run on the QIAsymphony Rotor-Gene Q (RGQ) modular laboratory workflow automation system, as well as QIAGEN's next-generation sequencing workflows currently in development. RGQ is a real-time PCR cycler with a proprietary rotary design that the company claims offers the highest reliability and quality of results due to the more homogenous temperature distribution in the reaction chamber.
"These new agreements add further depth to our extensive development portfolio of biomarkers with potential to provide valuable diagnostic information as well as personalized guidance for treatment decisions. The opportunity to create a new, improved paradigm in the important and vast field of rheumatoid arthritis is very exciting, and the other agreements further deepen our pipeline in oncology," says Peer M. Schatz, CEO of QIAGEN. "QIAGEN's global leadership in co-developing personalized healthcare solutions in partnership with pharmaceutical and biotechnology companies has become a key growth driver for our business. Our diagnostics are delivering molecular information to transform medical care for a wide range of diseases."
The four developments include a strategic equity investment in Drug Response Dx GmbH with the option to obtain worldwide rights to biomarkers for evaluation of rheumatoid arthritis (RA) patients to guide treatment with TNF-alpha inhibitors, which are widely prescribed for treatment of RA. Therapy with TNF-alpha inhibitors is successful in approximately 60 to 70 percent of RA patients, but treatment failure does not become apparent for about six months. A companion diagnostic to predict which RA patients are likely to respond to TNF-alpha inhibitors would improve quality of life for patients through tailored and earlier use of the most effective drugs, while also decreasing costs due to failed treatments.
Drug Response Dx, based in Hennigsdorf, Germany, is being financed at this stage by QIAGEN and High-Tech Gründerfonds GmbH, a German investor in early-stage companies and a co-founder of Drug Response Dx, which has developed proprietary RA biomarkers based on technology licensed from Max-Planck-Innovation.
In a second move, QIAGEN has agreed to license exclusive worldwide rights from Insight Genetics Inc., a molecular diagnostics company in Nashville, for the RET, ROS1 and DEPDC1 biomarkers for use in non-small cell lung cancer (NSCLC), the most common form of lung cancer. Collectively, RET, ROS1 and DEPDC1 mutations are estimated to be present in up to about one in 10 of all NSCLC cases, but so far there are no regulatory-approved commercial tests to reliably and efficiently identify these biomarkers. Previously, QIAGEN and Insight entered a licensing and co-development partnership for companion diagnostics focusing on the ALK gene, which several pharmaceutical companies are targeting for new anticancer treatments. The development of the EM4-ALK assay for use on the QIAsymphony automation system is progressing well, says Dr. Thomas Theuringer, QIAGEN's director of communications. Mutations of ALK are implicated in NSCLC and other malignancies, and several compounds known as ALK inhibitors are in clinical trials with one ALK inhibitor already on the market.
Also, QIAGEN Marseille (QIAGEN's subsidiary previously known as Ipsogen) has licensed exclusive worldwide rights to a biomarker for mutations of the HSP110 gene, which allows for identification of specific types of colorectal cancer, from Inserm Transfert, the technology transfer arm of the French National Institute of Health and Medical Research (INSERM) in Paris. QIAGEN intends to develop the biomarkers into a diagnostic test for routine use in the diagnostic workup of colorectal cancer patients.
Diagnosing HSP110 mutations holds promise for enabling doctors to identify so-called microsatellite instability (MSI), which occurs in about 15 percent of all colorectal cancers. Patients with MSI have a more favorable outcome. On the other hand, about one-third of these patients with MSI have Lynch syndrome, an inherited form of colorectal cancer that is linked to a higher risk of developing a second cancer. The detection of this mutation is expected to help in assessing the MSI phenotype of colorectal cancer.
Finally, QIAGEN has entered into a multiyear development and license agreement with IntelligentMDx under which the latter will design, develop and manufacture several undisclosed CE-marked and FDA cleared diagnostic tests for use on QIAGEN's flagship QIAsymphony RGQ automated platform. The undisclosed assays being developed by IntelligentMDx are planned to be incorporated into QIAGEN's growing menu of molecular diagnostic assays and will be distributed by QIAGEN worldwide. QIAGEN has also retained the rights to assume manufacturing of the assays pursuant to volume considerations.
Of patented versus proprietary protection
Commenting on the return of the Myriad Genetics case to the U.S. Supreme Court for review, Courtenay Brinckerhoff, a partner with Foley & Lardner LLP and vice chair of the firm's Chemical, Biotechnology & Pharmaceutical practice, notes that, in the end, Europe may provide broader patentability. That said, she believes that "if the court leaves room for claims, people will continue to seek patents." But if that proves too difficult, she thinks there may be a movement to greater reliance on trade secrets.
Already QIAGEN, appears to have embarked on such a path, at least in part.
"Patents are important to incentivize the development of innovative gene-based diagnostics," says Dr. Thomas Theuringer, the company's PR director. "However, they are a not decisive for QIAGEN's business model," he quickly adds. "We run a product business, not a service business, and we make all of our products available to researchers and patients worldwide within their given license restrictions. The competitive environment in fields QIAGEN is focusing on, such as personalized healthcare, is shaped by factors such as partnerships, regulatory and reimbursement regimes and access to samples, not only by intellectual properties.
"Compared with Myriad's patents on BRCA1 and 2, the IP landscape for biomarkers can be more complex," Theuringer adds. "Take KRAS, for example, involving claims from Genentech, Johns Hopkins, Genzyme, Amgen and others, and applying to different mutations, indications and drug targets. We vigorously defend our patents."