GLOSTRUP, DENMARK-- Dako, worldwide provider of cancer diagnostic solutions, has signed an agreement with Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), to collaborate on the regulatory submissions of Dako's HercepTest(TM) and HER2 FISH pharmDx(TM) as companion diagnostics for Herceptin (trastuzumab) in patients with advanced HER2-positive stomach (gastric) cancer.
The collaboration involves the use of Dako's extensive experience in developing cancer diagnostic tests to identify cancer patients who may receive greater benefits from a certain therapy.
Under the terms of the agreement, Dako and Genentech will collaborate on regulatory submissions for HercepTest(TM) and HER2 FISH pharmDx(TM) in the U.S. market to identify patients with stomach cancer who may be eligible for treatment with Herceptin if Herceptin is approved for use against that disease.
Based on the Herceptin ToGA Phase III study results, which were presented on May 31, 2009 at the American Society for Clinical Oncology Annual Meeting in Orlando, Florida, Genentech may seek regulatory approvals in the U.S. for the use of Herceptin in advanced HER2-positive stomach cancer.
"Herceptin and Dako's companion diagnostics HercepTest(TM) and HER2 FISH pharmDx(TM) have brought significant benefit to women with HER2-positive breast cancer. We are very excited to work with Genentech to extend these successful companion diagnostics to patients with stomach cancer," says Lars Holmkvist, CEO and President of the Dako Group.
The collaboration is in line with Dako's ongoing strategy to combine its strengths with biotechnology and pharmaceutical companies to develop the offering of Dako's companion diagnostic assays.
"We are very pleased to announce our collaboration with Genentech to potentially further expand the market for targeted therapies. We see great potential in a strong collaborative approach between biotechnology and pharmaceutical companies, and diagnostic companies, in targeting the right drugs for the right patients, both to improve patient care and more efficiently manage health care costs," says Lars Holmkvist.
According to the American Cancer Society, gastric or stomach cancer is the second leading cause of cancer-related death globally with over 1,000,000 new cases diagnosed each year. Early diagnosis is challenging because most patients do not show symptoms in the early stage, and in the United States, most patients are diagnosed in a later stage of gastric cancer. Approximately 22% of stomach tumors are HER2-positive. This rate is the same in Europe and in Asia, where stomach 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 breast cancer eligible for treatment with Herceptin, and was launched in 1998. The joint approval of Herceptin and HercepTest(TM) was the first example in history of a drug linked to a companion diagnostic.
HER2 FISH pharmDx(TM) Kit is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification and is indicated as an aid in the assessment of patients for whom Herceptin treatment is being considered.
Anne Thommesen, Dako, Director of Corporate Communications
Cell: +45 4063 9593
Important Information about Herceptin
Herceptin is approved for the adjuvant treatment of HER2-overexpressing, node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer. Herceptin can be used as part of a treatment regimen including doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; as a single agent following multi-modality anthracycline-based therapy.
Herceptin in combination with paclitaxel is approved for the first line treatment of HER2-overexpressing metastatic breast cancer. Herceptin as a single agent is approved for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Important safety information
Herceptin treatment can result in heart problems, including those without symptoms (reduced heart function) and those with symptoms (congestive heart failure). Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported. Worsening of low white blood cell counts associated with chemotherapy has also occurred. Herceptin can cause low amniotic fluid 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, increased coughing, headache, fatigue, shortness of breath, rash, low white and red blood cells counts, and muscle pain.
Please visit www.gene.com for the Herceptin full prescribing information, including Boxed WARNINGS and additional important safety information.
Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako's know-how, reagents, instruments and software to make precise diagnoses and determine the most effective treatment for patients suffering from cancer. Employing more than 1000 people and operating in more than 70 countries, Dako covers essentially all of the global anatomic pathology markets. Dako is owned by a private equity fund, EQT. www.dako.com
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