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Monogram and Merck to Conduct Erbitux® Biomarker Study

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Monogram Biosciences, Inc. has announced that it has entered into an agreement with Merck KGaA, Darmstadt, Germany to conduct a cancer biomarker study with application to Erbitux® (cetuximab), Merck KGaA's IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR) found on many cancer cells.

Monogram, utilizing its proprietary eTag™ 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.

“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.”