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QIAGEN and Roche Settle Dispute Over Distribution Agreement for TheraScreen Companion Diagnostics

Thursday, May 27, 2010 General News
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Under the terms of the agreement, Roche maintained its rights todistribute the two assays it currently distributes (KRAS and EGFR) under theDxS TheraScreen(R) label and, under certain conditions, to distribute futureversions thereof. QIAGEN obtained rights to distribute these assays under theQIAGEN label and also obtained exclusive distribution rights for all otherassays, including future assays, developed and manufactured at QIAGEN'sManchester subsidiary. QIAGEN intends to use the QIAGEN TheraScreen(R) labelfor the assays it distributes. QIAGEN also granted Roche the option to extendthe term of the distribution agreement for one of the assays, theTheraScreen(R) EGFR assay, beyond the term of this agreement which ends in2011.
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"We are pleased to have reached this agreement with Roche", said PeerSchatz, CEO of QIAGEN. "The agreement provides a clear distribution plan forQIAGEN's pioneering TheraScreen(R) companion diagnostics. Companiondiagnostics help physicians to customize therapies, greatly reduce healthcarecosts and prevent harmful treatments for patients suffering from seriousdiseases."
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"We are pleased to maintain our distribution agreement and to continue toprovide access to DxS TheraScreen companion diagnostics that have thepotential to improve cancer patient care," said Paul Brown, Ph.D., Presidentand CEO of Roche Molecular Systems.

Background:

Personalized healthcare approaches are based on patients' molecularprofiles and already play an increasingly important role for the treatment ofcardiovascular and neurological diseases and - most prominently - cancer. Thenumber of molecular markers for various therapies and indications has beenincreasing steadily. Today, there are already 32 genomic biomarkersidentified by FDA in the context of FDA-approved drug labels. In the last tenyears the market for personalized healthcare drugs exceeded US$ 13 billion,reflecting a CAGR of 24%.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading globalprovider of sample and assay technologies. Sample technologies are used toisolate and process DNA, RNA and proteins from biological samples such asblood or tissue. Assay technologies are used to make such isolatedbio-molecules visible. QIAGEN has developed and markets more than 500 sampleand assay products as well as automated solutions for such consumables. Thecompany provides its products to molecular diagnostics laboratories, academicresearchers, pharmaceutical and biotechnology companies, and applied testingcustomers for purposes such as forensics, animal or food testing andpharmaceutical process control. QIAGEN's assay technologies include one ofthe broadest panels of molecular diagnostic tests available worldwide. Thispanel includes the digene HPV Test, which is regarded as a "gold standard" intesting for high-risk types of human papillomavirus (HPV), the primary causeof cervical cancer, as well as a broad suite of solutions for infectiousdisease testing and companion diagnostics. QIAGEN employs more than 3,500people in over 30 locations worldwide. Further information about QIAGEN canbe found at http://www.qiagen.com/.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader inresearch-focused healthcare with combined strengths in pharmaceuticals anddiagnostics. Roche is the world's largest biotech company with trulydifferentiated medicines in oncology, virology, inflammation, metabolism andCNS. Roche is also the world leader in in-vitro diagnostics, tissue-basedcancer diagnostics and a pioneer in diabetes management. Roche's personalizedhealthcare strategy aims at providing medicines and diagnostic tools thatenable tangible improvements in the health, quality of life and survival ofpatients. In 2009, Roche had over 80,000 employees worldwide and investedalmost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billionSwiss francs. Genentech, United States, is a wholly owned member of the RocheGroup. Roche has a majority stake in Chugai Pharmaceutical, Japan. For moreinformation: http://www.roche.com.

Certain of the statements contained in this news release may beconsidered forward-looking statements within the meaning of Section 27A ofthe 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 thestatements contained herein relating to QIAGEN's products, markets, strategyor operating results are forward-looking, such statements are based oncurrent expectations that involve a number of uncertainties and risks. Suchuncertainties and risks include, but are not limited to, risks associatedwith management of growth and international operations (including the effectsof currency fluctuations and risks of dependency on logistics), variabilityof operating results, the commercial development of the applied testingmarkets, clinical research markets and proteomics markets, nucleic acid-basedmolecular diagnostics market, and genetic vaccination and gene therapymarkets, competition, rapid or unexpected changes in technologies,fluctuations in demand for QIAGEN's, products (including fluctuations due tothe level and timing of customers' funding, budgets, and other factors), ourability to obtain regulatory approval of our infectious disease panels,difficulties in successfully adapting QIAGEN's products to integratedsolutions and producing such products, the ability of QIAGEN to identify anddevelop new products and to differentiate its products from competitors'products, market acceptance of QIAGEN's new products and the integration ofacquired technologies and businesses. For further information, refer to thediscussions in reports that QIAGEN has filed with, or furnished to, the U.S.Securities and Exchange Commission (SEC).GERMANTOWN, Maryland and HILDEN, Germany, May 26, 2010/PRNewswire-FirstCall/ -- QIAGEN N.V. (NASDAQ: QGEN [http://quotes.nasdaq.com/asp/SummaryQuote.asp?symbol=QGEN&selected=QGEN ];Frankfurt, Prime Standard: QIA [http://www.boerse-frankfurt.de/DE/index.aspx?pageID=35&ISIN=NL0000240000 ])today announced that it has signed an agreement with Roche Molecular SystemsInc., a unit of Roche Holding AG (ROG.VX [http://www.reuters.com/finance/stocks/overview?symbol=ROG.VX ]), resolving adispute over distribution rights for a set of companion diagnostic productsdeveloped and manufactured by QIAGEN's Manchester subsidiary DxS Ltd.Subsequently, the parties withdrew their claims filed against one another inthe action that was pending in the US District Court for the SouthernDistrict of New York.

SOURCE Qiagen
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