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Almac Diagnostics Partners with Merck, MRC on Companion Diagnostics Project

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By Justin Petrone

Almac Diagnostics last week said it will collaborate with Merck KGaA and the UK's Medical Research Council on a study of potential biomarkers of response to the cancer drug Erbitux (cetuximab).

The deal is the latest in a string of agreements that have paired the Disease Specific Array maker with major pharmaceutical companies to develop biomarkers that can later be used in companion diagnostics.

In the new project, Almac, Merck, and the MRC will use metastatic colon cancer samples from MRC's COIN trial — a phase III, multicenter, three-arm study of first-line treatment of metastatic colon cancer — to assess the potential biomarkers. Cetuximab has been approved in Europe in combination with standard chemotherapy as a first-line treatment for mCRC in patients with KRAS wildtype tumors.

Craigavon, Northern Ireland-based Almac said that it will conduct profiling and data analysis of the samples and assess potential biomarkers, beyond KRAS, in the context of combination therapy with cetuximab. Further terms of the alliance were not disclosed.

Almac Scientific Liaison Manager Austin Tanney told BioArray News this week that the new agreement is the first of its kind with Merck. Last year, Almac announced similar deals with Pfizer and Lilly, and Tanney said they are indicative of Almac's growing companion diagnostics business.

"Our focus in Almac has always been on biomarkers and their diagnostic application," Tanney said. "Over the last few years we have been increasingly focused on companion diagnostics."

In September 2009, Almac announced a partnership with Lilly UK to develop a companion diagnostic for Alimta (pemetrexed) with cisplatin as a combination therapy for non-squamous non-small cell lung cancer.

In May last year, the firm also inked a deal with Pfizer and researchers from the Pan-European Trials in Adjuvant Colon Cancer effort to discover molecular subtypes, biomarkers, and drug targets related to colorectal cancer (BAN 5/26/2009).

At the time of the Pfizer announcement, Tanney told BioArray News that pharma companies have increasingly been looking to outsource their drug-development work. "Pharma doesn't necessarily want to make diagnostics; they want to sell drugs," Tanney said at the time. "So we are seeing more interest in pharma companies partnering with diagnostics firms like Almac and outsourcing that kind of work."

Almac typically uses its Disease Specific Array platform in these research programs, though Tanney said that the firm will be conducting quantitative PCR profiling in the Merck study. Almac DSAs, manufactured on the Affymetrix GeneChip platform, are available for the study of prostate, lung, ovarian, breast, and colorectal cancers.

Almac separately is developing a number of diagnostic assays on the Affy platform for indications like colorectal, breast, and lung cancer.

Still, it has been the companion diagnostics work for biopharma that has required the firm to grow. In December 2009, the company opened a new bioinformatics office in Manchester, UK, to support the new projects.

While the firm did not disclose the number of people it employs, it said that head count in the Diagnostics business, which also has facilities in Durham, NC, grew 15 percent in the UK and 10 percent in the US last year. Almac, which also has sciences, clinical services, clinical technologies, and pharma services divisions, currently employs around 2,500 worldwide (BAN 12/8/2009).

"As the company has evolved, our growth has always been focused on biomarker discovery and development," Tanney said this week of the firm's ongoing expansion. "We initially developed our infrastructure with a primary focus on the development of our own internal pipeline of diagnostics," he said. "The expansion of this resource to accommodate companion diagnostic development partnerships has been very much a part of our core strategy."

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