November 01, 2011 -- Absorption Systems, a leader in testing drugs for ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity), today announced that patents have issued in Europe (no. 2084529) and Panama (no. 87554-01) covering its novel Breast Cancer Resistance Protein (BCRP) knockdown cell line within the company’s CellPort Technologies® brand. These international patents extend the protection of the intellectual property beyond US patent number 7,795,019. Absorption Systems’ proprietary cell lines enable pharmaceutical and biotechnology companies to definitively predict clinical drug-drug interactions (DDIs) involving drug transporters.
DDIs, which can cause side effects, therapeutic failure, or death, represent a critical healthcare problem, particularly among the elderly due to the fact that most elderly people take multiple medications. According to an article in the Journal of the American Medical Association, approximately 4% of older Americans (2.2 million people) are at risk of a major DDI, nearly all of which could be avoided with identification, awareness, and avoidance of such combinations. Absorption Systems’ Chief Scientist, Dr. Ismael Hidalgo, has led an unwavering commitment to extensive research and development in preclinical ADMET testing. He said, “We continually invest in R&D for more definitive test systems that help pharmaceutical and biopharmaceutical companies decide which drugs to advance into clinical testing. It is our mission to arm them with data that predicts clinical outcomes accurately, and we take that responsibility very seriously.”
CellPort Technologies is a suite of in vitro test systems designed to provide definitive data regarding interactions between drugs and specific transporter proteins. Drug transporters, including BCRP, have been identified by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as key mediators of unintended DDIs.* To create its new test systems, Absorption Systems took the opposite approach to older models in which a transporter of interest is over-expressed. Starting with the Caco-2 human epithelial cell line, scientists used RNA interference to knock down the expression of one efflux transporter at a time, in such a way that each knockdown phenotype is stable and long-lasting. By using the knockdown cell lines in parallel with control cells, it becomes very clear, by process of elimination, if a drug interacts with a specific drug transporter.
This use of the counter-intuitive knockdown approach was the brainchild of Dr. Hidalgo, who led the development and validation of these innovative test systems and added, “These patents further validate our commitment to research on and the development of better, more predictive tools that reduce risks and ultimately save lives. CellPort Technologies can provide, very efficiently and definitively, data on transporters that is now required by regulatory agencies such as the FDA. And this technology is exclusive to Absorption Systems.”
To learn more about CellPort Technologies and to view a video on the patented knockdown cell lines, visit www.absorption.com/cellport.
*FDA draft guidance on drug interaction studies is available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072101.pdf.
*EMA draft guideline on the investigation of drug interactions is available at
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/05/WC500090112.pdf.
*The influential International Transporter Consortium white paper on transporters and drug development is available at http://www.nature.com/nrd/journal/v9/n3/full/nrd3028.html.
About Absorption Systems
Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. The company’s mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based tests systems for drug transporter characterization, exemplifies Absorption Systems’ commitment to innovation and is soon to be an industry assay standard for in vitro drug interaction assessment. Absorption Systems has facilities near Philadelphia, PA, and in San Diego, CA, and serves customers throughout the world. For information on the company’s comprehensive contract services and applied research programs, please visit http://www.absorption.com
