Almac partners with Merck KGaA and the MRC to assess markers of response to Cetuximab therapy

April 12, 2010

Samples from COIN trial to be used to assess markers of response to cetuximab

CRAIGAVON, NORTHERN IRELAND, 12 April 2010

Almac, Merck KGaA, Darmstadt, Germany, and the Medical Research Council (MRC), a UK-based, publicly-funded organization dedicated to improving human health, have entered into a partnership to undertake a study in metastatic colorectal cancer (mCRC) using samples from the MRC COIN trial. The aim of the study is to assess potential biomarkers of response to cetuximab (Erbitux®).

The value of biomarkers in optimizing treatment outcomes has already been recognized. The American Society of Clinical Oncology (ASCO) acknowledged in 2008 the use of the KRAS as a predictive biomarker for cetuximab in newly diagnosed advanced colon cancer as a “major research advance” that will “help guide treatment for each patient, increasing efficacy while eliminating unnecessary adverse effects in those who will not benefit from the treatment.”1

This personalized treatment approach was also recognized by regulatory bodies such as the European Medicines Agency (EMA) which approved cetuximab in combination with standard chemotherapy as a 1st-line treatment for mCRC in patients with KRAS wildtype tumors.

Almac will utilize samples from the COIN trial to carry out quantitative polymerase chain reaction profiling and data analysis to assess other potential biomarkers in the context of combination therapy with cetuximab.

Prof. Tim Maughan, Director, Wales Cancer Trials Unit, explained

“The MRC COIN trial is the largest trial of therapy in patients with advanced colorectal cancer and tested the addition of cetuximab to oxaliplatin based chemotherapy regimen. This collaboration will enable us to identify whether biomarkers apart from the Kras status alone further define which patients may benefit most from the addition of cetuximab to chemotherapy”

Prof. Paul Harkin, president of Almac Diagnostic Services, said;

“Almac are delighted to once again be involved in such an important study. The use of retrospective analysis from formalin fixed paraffin embedded samples will be one of the keys to successfully delivering better molecular diagnostics, which is paramount in the development of personalized medicine”

The MRC COIN study is a phase III, multicenter, three arm study in 1st-line treatment of mCRC. The study focuses on examining whether the combination of oxaliplatin and cetuximab with fluoropyrimidine chemotherapy improves patient outcomes.

Ends

1. Winer E, et al. J Clin Oncol 2009;27:812-26.

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Notes to Editors

About Almac Diagnostic Services

Almac Diagnostic Services is a personalized medicine company with particular expertise in companion diagnostic development, pharmacodynamic biomarkers, prognostic test development and drug target discovery. We have our own pipeline of IVD tests, which have been developed from FF & FFPE tissue. We utilize our experience, expertise and unique Cancer DSA™ technology to partner with our customers enabling translational genomic solutions.

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,600 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

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