Monogram Biosciences and Merck to Conduct Erbitux(R) Biomarker Study
SOUTH SAN FRANCISCO, Calif. and DARMSTADT, Germany, Oct. 24
/PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) announced today that it has entered into an agreement with Merck KGaA, Darmstadt, Germany (Xetra: Merck KGaA) to conduct a cancer biomarker study with application to Erbitux(R)(cetuximab), Merck KGaA's IgG1 monoclonal antibody specifically targeting the epidermal growth factor receptor (EGFR) found on many cancer cells. Monogram, utilizing its proprietary eTag(TM) assays, will test formalin-fixed, paraffin-embedded (FFPE) tumor samples from patients with colorectal cancer before they are treated with Erbitux to evaluate the utility of these assays in identifying patients who would most likely benefit from Erbitux. Monogram will test the samples for EGFR-containing receptor dimers, which Monogram has identified as potential biomarkers for predicting response to Erbitux. These biomarkers represent activated, functioning targets for the drug and control signal transduction pathways involved in tumor cell proliferation, survival and angiogenesis. The parties will then compare Monogram's predictions of response based upon eTag assay analysis with actual clinical outcomes. Merck KGaA will make payments to Monogram for the project. Other financial details were not disclosed. "We are pleased to be working with Merck KGaA on this project. Merck KGaA played a critical role in demonstrating the clinical efficacy of Erbitux and gaining its approval, and they have made a strong and broad commitment to targeted oncology therapies," stated William D. Young, Monogram's Chairman and Chief Executive Officer. "We believe that predictive diagnostics will play an expanding role in clinical testing and clinical practice in this field. Tests like our eTag assays may empower physicians, benefit patients and enhance clinical medicine by linking molecular analysis of the individual patient's disease to the prescription of critical drugs like Erbitux." This is one of nine collaborations that Monogram has had with leading pharmaceutical and biotechnology companies in oncology. These alliances have been focused on the ability of eTag assays to identify activated drug targets or signaling pathways and their correlation with drug activity in cell line, xenograft and human clinical tumor samples. "In HIV resistance testing, about a third of our business has historically come from collaborations with pharmaceutical companies and we expect a similar pattern to develop in oncology," said Young. "We look forward to establishing additional collaborations with these and other companies that have oncology drug development programs." About the eTag System Monogram's eTag assays enable detailed analysis of protein drug targets and signaling pathways in cancer cells, including FFPE samples, which is the standard format in most pathology labs. The assays can provide information on a drug's mechanism of action, selectivity and potency in a biological setting in pre-clinical research, and enable enrichment or selection of clinical trial populations later in a drug's development. In addition, Monogram believes these assays may ultimately be used to help physicians better determine whether certain therapies are more appropriate for individual cancer patients, and whether to combine therapies with different mechanisms or properties. The first commercially available activated receptor test panel based on eTag technology, focused on the EGFR/HER receptor family, is planned to be introduced in 2006. About Monogram Biosciences, Inc. Monogram, formerly ViroLogic, Inc., develops and commercializes innovative products to help guide and improve the treatment of infectious diseases, cancer and other serious diseases. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. Monogram's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information can be found at www.monogrambio.com. About Erbitux Erbitux(R) is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately five percent of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe. Erbitux has already obtained market authorization in 45 countries: Switzerland, the U.S., Mexico, Argentina, Chile, Iceland, Norway, the European Union, Canada, Peru, Australia, Croatia, Israel, Bulgaria, Panama, Guatemela, Colombia, Ecuador, Singapore, Hong Kong, and South Korea for the use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. In the U.S., Canada, Argentina, Chile, Mexico, Peru, Singapore, Australia, Panama, Colombia, Guatemala, Ecuador, and Hong Kong, Erbitux is also approved for single agent usage. About Merck KGaA Merck KGaA, Darmstadt, Germany is a global pharmaceutical and chemical company with sales of EUR 5.9 billion in 2004, a history that began in 1668, and a future shaped by 28,600 employees in 54 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 73% interest and free shareholders own the remaining 27%. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917. Merck KGaA licensed the right to market Erbitux outside the U.S. and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, Merck KGaA has co-exclusive marketing rights with ImClone Systems. NOTE: eTag(TM) is a registered trademark of Monogram Biosciences, Inc. Erbitux(R) is a registered trademark of ImClone Systems, Incorporated of New York. FORWARD LOOKING STATEMENTS Certain statements in this press release are forward-looking. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties relating to the performance of our products; the ability of our eTag assays to predict response to Erbitux or other therapeutic agents, our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the timing and ultimate size of pharmaceutical company clinical trials; whether payors will authorize reimbursement for its products; whether the FDA or any other agency will decide to regulate Monogram's products or services; whether the Company will encounter problems or delays in automating its processes; whether licenses to third party technology will be available; whether Monogram is able to build brand loyalty and expand revenues; and whether Monogram will be able to raise sufficient capital when required. For a discussion of other factors that may cause Monogram's actual events to differ from those projected, please refer to the Company's most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
SOURCE Monogram Biosciences, Inc.
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