Almac Diagnostic Services in new deal to provide unique process to extract genetic information from Clinical Trial samples
May 8, 2008
Newly validated capability to be used in gastrointestinal cancer study
The Almac Group today announced a deal with Biogen Idec Inc (NASDAQ: BIB) a global biotechnology company based in Cambridge, Mass., to use Almac Diagnostic Services’ expertise in extracting genetic information from formalin fixed paraffin embedded tissue (FFPE) for SNP analysis in a Phase II trial of one of its drug candidates for the treatment of gastrointestinal stromal tumors (GIST).
Almac Diagnostic Services has developed unique capabilities to work with FFPE that allow researchers to use the samples in qPCR and microarray SNP genotyping and gene expression studies. Previously, such genetic analyses were not routinely possible in clinical trials due to degradation of the tissue samples during fixation and storage. This service is now available from Almac’s two facilities in Europe and the US.
Most clinical material is stored as FFPE tissue blocks, which, in the past, rendered the material unsuitable for genetic analysis. Almac has developed a proprietary process that now makes it possible to unlock the genetic information stored within these samples. The newly validated process enables qPCR and microarray SNP genotyping from FFPE samples. This process will be used in the Biogen Idec clinical trial.
Professor Paul Harkin, President and MD, Almac Diagnostic Services said: “Our validated processes have led to a huge shift in conventional thinking in how we handle the genetic information trapped in the nearly 400 million FFPE samples worldwide. Our approach means that we can now access a wide range of genetic material for analysis now and in the future. Harnessing and accessing the genetic information in clinical samples will change the way pharmaceutical and biotech companies examine results from their clinical trials. These developments will enable researchers to make significant advances towards personalised medicine.”
Julie Ranuio-Kelley, Senior Associate Scientist at Biogen Idec said: “This newly validated approach means that we can now access the full genetic information contained in our clinical trial samples. This will allow us to uncover biomarkers that will help us discover additional drug candidates and identify specific patient populations that will benefit from a particular treatment.”
Contact: Michael Sloan
T: + 44 (0)28 3833 7575
T: + 1 415 797 2607
About Almac Diagnostic Services
Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academic customers, and specialises in working with fresh and formalin fixed paraffin embedded (FFPE) tissue. They partner with customers for biomarker discovery and validation, and provide bioinformatic solutions and genomic services. Almac Diagnostic Services have also developed their range of Cancer DSATM research tools, the first disease specific transcriptome based microarrays.
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/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including world leaders in the pharmaceutical and biotech sectors. The company has 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit www.almacgroup.com.
All statements in this press release that are not historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Biogen Idecs’ “expectations,” “beliefs,” “hopes,” “intentions,” “strategies” or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Biogen Idec from those projected, including, but not limited to: risks and uncertainties relating to commercial success of the agreement with Almac Diagnostic Services discussed in this press release; risks of the company’s ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses; uncertainties related to technological approaches, manufacturing and product development; personnel retention; uncertainties related to cost and pricing of Biogen Idec products; dependence on collaborative partners; uncertainties related to sole-source suppliers; risks associated with past and future acquisitions; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Biogen Idec’s Form 10-K for the year ended December 31, 2006, and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Biogen Idec expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Biogen Idec’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.