Dako enters collaboration with Genentech on diagnostic tests for
patients with stomach cancer
(Thomson Reuters ONE) - Dako, worldwide provider of cancer diagnostic solutions, has signedan agreement with Genentech, Inc., a wholly-owned member of the RocheGroup (SIX: RO, ROG; OTCQX: RHHBY), to collaborate on the regulatorysubmissions of Dako's HercepTest(TM) and HER2 FISH pharmDx(TM) ascompanion diagnostics for Herceptin® (trastuzumab) in patients withadvanced HER2-positive stomach (gastric) cancer.The collaboration involves the use of Dako's extensive experience indeveloping cancer diagnostic tests to identify cancer patients whomay receive greater benefits from a certain therapy.Under the terms of the agreement, Dako and Genentech will collaborateon regulatory submissions for HercepTest(TM) and HER2 FISHpharmDx(TM) in the U.S. market to identify patients with stomachcancer who may be eligible for treatment with Herceptin if Herceptinis approved for use against that disease.Based on the Herceptin ToGA Phase III study results, which werepresented on May 31, 2009 at the American Society for ClinicalOncology Annual Meeting in Orlando, Florida, Genentech may seekregulatory approvals in the U.S. for the use of Herceptin in advancedHER2-positive stomach cancer."Herceptin and Dako's companion diagnostics HercepTest(TM) and HER2FISH pharmDx(TM) have brought significant benefit to women withHER2-positive breast cancer. We are very excited to work withGenentech to extend these successful companion diagnostics topatients with stomach cancer," says Lars Holmkvist, CEO and Presidentof the Dako Group.The collaboration is in line with Dako's ongoing strategy to combineits strengths with biotechnology and pharmaceutical companies todevelop the offering of Dako's companion diagnostic assays."We are very pleased to announce our collaboration with Genentech topotentially further expand the market for targeted therapies. We seegreat potential in a strong collaborative approach betweenbiotechnology and pharmaceutical companies, and diagnostic companies,in targeting the right drugs for the right patients, both to improvepatient care and more efficiently manage health care costs," saysLars Holmkvist.According to the American Cancer Society, gastric or stomach canceris the second leading cause of cancer-related death globally withover 1,000,000 new cases diagnosed each year. Early diagnosis ischallenging because most patients do not show symptoms in the earlystage, and in the United States, most patients are diagnosed in alater stage of gastric cancer. Approximately 22% of stomach tumorsare HER2-positive. This rate is the same in Europe and in Asia, wherestomach cancer is particularly frequent.About HercepTest(TM) and HER2 FISH pharmDx(TM)HercepTest(TM) (Dako's pharmDx test) is an immunohistochemistry (IHC)assay used to identify patients with HER2-positive metastatic breastcancer eligible for treatment with Herceptin, and was launched in1998. The joint approval of Herceptin and HercepTest(TM) was thefirst example in history of a drug linked to a companion diagnostic.HER2 FISH pharmDx(TM) Kit is a direct fluorescence in situhybridization (FISH) assay designed to quantitatively determine HER2gene amplification and is indicated as an aid in the assessment ofpatients for whom Herceptin treatment is being considered.Media contactAnne Thommesen, Dako, Director of Corporate CommunicationsCell: +45 4063 9593Important Information about HerceptinHerceptin is approved for the adjuvant treatment ofHER2-overexpressing, node-positive or node-negative (ER/PR-negativeor with one high-risk feature) breast cancer. Herceptin can be usedas part of a treatment regimen including doxorubicin,cyclophosphamide, and either paclitaxel or docetaxel; with docetaxeland carboplatin; as a single agent following multi-modalityanthracycline-based therapy.Herceptin in combination with paclitaxel is approved for the firstline treatment of HER2-overexpressing metastatic breast cancer.Herceptin as a single agent is approved for treatment ofHER2-overexpressing breast cancer in patients who have received oneor more chemotherapy regimens for metastatic disease.Important safety informationHerceptin treatment can result in heart problems, including thosewithout symptoms (reduced heart function) and those with symptoms(congestive heart failure). Some patients have had serious infusionreactions and lung problems; fatal infusion reactions have beenreported. Worsening of low white blood cell counts associated withchemotherapy has also occurred. Herceptin can cause low amnioticfluid levels and harm to the fetus when taken by a pregnant woman.The most common side effects associated with Herceptin were fever,nausea, vomiting, infusion reactions, diarrhea, infections, increasedcoughing, headache, fatigue, shortness of breath, rash, low white andred blood cells counts, and muscle pain.Please visit www.gene.com for the Herceptin full prescribinginformation, including Boxed WARNINGS and additional important safetyinformation.Dako, based in Denmark, is a global leader in tissue-based cancerdiagnostics. Hospital and research laboratories worldwide use Dako'sknow-how, reagents, instruments and software to make precisediagnoses and determine the most effective treatment for patientssuffering from cancer. Employing more than 1000 people and operatingin more than 70 countries, Dako covers essentially all of the globalanatomic pathology markets. Dako is owned by a private equity fund,EQT. www.dako.comThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 11.08.2009 - 07:00 Uhr
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