QIAGEN and Roche settle dispute over distribution agreement for TheraScreen companion diagnostics
Germantown, MD and Hilden, Germany, May 26, 2010 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced that it has signed an agreement with Roche Molecular Systems Inc., a unit of Roche Holding AG (ROG.VX), resolving a dispute over distribution rights for a set of companion diagnostic products developed and manufactured by QIAGEN's Manchester subsidiary DxS Ltd. Subsequently, the parties withdrew their claims filed against one another in the action that was pending in the US District Court for the Southern District of New York.
Under the terms of the agreement, Roche maintained its rights to distribute the two assays it currently distributes (KRAS and EGFR) under the DxS TheraScreen® label and, under certain conditions, to distribute future versions thereof. QIAGEN obtained rights to distribute these assays under the QIAGEN label and also obtained exclusive distribution rights for all other assays, including future assays, developed and manufactured at QIAGEN's Manchester subsidiary. QIAGEN intends to use the QIAGEN TheraScreen® label for the assays it distributes. QIAGEN also granted Roche the option to extend the term of the distribution agreement for one of the assays, the TheraScreen® EGFR assay, beyond the term of this agreement which ends in 2011.
"We are pleased to have reached this agreement with Roche", said Peer Schatz, CEO of QIAGEN. "The agreement provides a clear distribution plan for QIAGEN's pioneering TheraScreen® companion diagnostics. Companion diagnostics help physicians to customize therapies, greatly reduce healthcare costs and prevent harmful treatments for patients suffering from serious diseases."
"We are pleased to maintain our distribution agreement and to continue to provide access to DxS TheraScreen companion diagnostics that have the potential to improve cancer patient care," said Paul Brown, Ph.D., President and CEO of Roche Molecular Systems.
Personalized healthcare approaches are based on patients' molecular profiles and already play an increasingly important role for the treatment of cardiovascular and neurological diseases and - most prominently - cancer. The number of molecular markers for various therapies and indications has been increasing steadily. Today, there are already 32 genomic biomarkers identified by FDA in the context of FDA-approved drug labels. In the last ten years the market for personalized healthcare drugs exceeded US$ 13 billion, reflecting a CAGR of 24%.
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 more than 3,500 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: http://www.roche.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 are forward-looking, such statements are based on current expectations 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 and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, 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 its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).