QIAGEN to develop new companion diagnostic for compound in clinical trials for blood cancers
QIAGEN assay for JAK2 V617F mutation aims to identify patients more likely to respond to Lilly's ‘JAK2 inhibitor' and to monitor responses to therapy
- Lilly will co-develop companion diagnostic
- QIAGEN's exclusive access to JAK2 biomarker underpins potential future expansion with additional Pharma compounds targeting gene
Germantown, Md., September 6, 2011 - QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced that it has entered into a partnership with Eli Lilly and Company for the development, manufacturing and commercialization of a molecular companion diagnostic for an early stage investigational compound currently being developed by Lilly. Financial terms of the agreement were not disclosed.
Lilly's proprietary compound, called a JAK2 inhibitor, targets the Janus kinase 2 (JAK2) gene, which has been shown to play a role in myeloproliferative neoplasms, a variety of blood cancers that cause blood cells to grow abnormally.
Under the terms of the agreement, QIAGEN will develop a new companion diagnostic test that will provide both qualitative and quantitative results for JAK2 V617F. The assay is intended to identify patients most likely to benefit from treatment with inhibitors of the pathway. The scope of the partnership includes development and use of the QIAGEN JAK2 assay during clinical trials and also covers manufacturing and joint commercialization of the diagnostic product in parallel with the Lilly compound.
QIAGEN gained exclusive access to the JAK2 biomarker through an agreement with Ipsogen, a French company that is a pioneer in profiling and biomarkers for leukemia and other blood cancers. In June, QIAGEN announced a proposal to fully acquire Ipsogen through a process that is under way. The JAK2 pathway is considered to bring high value to drug development in terms of defining and directing the right therapies for patients, and therefore represents a very important target of R&D initiatives in the pharmaceutical industry.
"The collaboration with Lilly is a strong testament to QIAGEN's capabilities in companion diagnostics, biomarkers and personalized healthcare," commented Dr. Stephen Little, Vice President Personalized Healthcare at QIAGEN. "We look forward to developing the potential for this innovative diagnostic-therapeutic combination to improve the standard of care for patients suffering from these blood cancers."
QIAGEN currently offers about 20 tests for use in Personalized Healthcare and has partnerships under way with more than 15 pharma companies to co-develop companion diagnostics.
JAK2 V617F testing is currently being offered by clinical labs in the form of lab-developed tests (LDTs). The new PCR-based companion diagnostic will be exclusively marketed by QIAGEN and will run on QIAGEN's Rotor-Gene Q instrument. QIAGEN also intends to seek regulatory approval for full automation of the workflow on the QIAsymphony RGQ, a novel modular sample-to-result automation platform launched by QIAGEN last year.
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 about 3,700 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).