Sigma(R) Life Science and Axiogenesis Collaborate to Market More Predictive iPSC-Based Assays and Services for Preclinical Cardiotoxicity Screening

ST. LOUIS, July 31, 2012 /PRNewswire/ -- Sigma-Aldrich® Corporation (Nasdaq: SIAL) today announced that Sigma Life Science, its innovative biological products and services research business, has signed an agreement with Axiogenesis to market mouse induced pluripotent stem (iPS) cell-derived cardiomyocytes and smooth muscle cells. In contrast to short-lived, tissue-derived primary cells that predominate preclinical drug discovery and cardiotoxicity screens, Sigma Life Science and Axiogenesis' iPS cell-derived primary cells enable long-term studies that are necessary to more accurately predict cardiotoxicity. These derived cell types are available as ready-to-order cells, application-specific kits and custom services catering to novice and expert users. Details are available at www.sigma.com/cardiac.

"Costly drug candidate failures in clinical trials are most frequently caused by cardiac safety issues," said John Listello, Market Segment Manager of Stem Cell Research and Regenerative Medicine at Sigma Life Science. "Early identification of these cardiac liabilities is hindered by the lack of reliable and standardized cardiomyocyte cell culture models.

"Avoiding clinical trial failures is a principle driver for the Sigma/Axiogenesis collaboration, which provides drug developers large numbers of these consistent cell culture models. This partnership deepens Sigma Life Science's commitment to alleviate critical deficiencies in ADME/Toxicology screening and preclinical development through application of iPS cell technology recently licensed from Kyoto University, CompoZr® Zinc Finger Nucleases, and the SAGEspeed Custom Animal Model Development program."

Cardiomyocytes for research and screening purposes are commonly isolated from available animal and patient tissue. The predictive utility of tissue-derived cardiomyocyte pools is limited because they do not spontaneously beat, gradually dedifferentiate into fetal-like physiological states, and contain a high percentage of contaminating cell types, such as fibroblasts that can rapidly override the culture. As a result, many critical long-term studies that could identify cardiac liabilities prior to clinical trials cannot be performed.

"In contrast, Axiogenesis' iPS cell-derived cardiomyocytes enable long-term studies that are impossible to perform in tissue-derived samples, such as accumulation studies that examine the effects of chronic dosing for several weeks at physiologically relevant, picogram levels. Accumulation patterns from such long-term studies can identify toxic compounds whose toxicity was not detectable through alternative experiments," concludes Listello.

Cardiomyocytes derived from Axiogenesis' iPS cell lines maintain physiologically-relevant biology, purity, and spontaneous beating for longer than 28 days. These iPS-cell derived cardiomyocytes are validated for functional electrophysiology, calcium-flux and calcium-wave analysis, cardiac cytotoxicity, mitochondrial metabolism, and as a disease model for cardiac hypertrophy.

Sigma Life Science's existing stem cell product portfolio includes custom iPS cell CompoZr ZFN-mediated genetic engineering, serum-free cell culture products, cell culture media, 3D matrices, growth factors, and antibodies, providing uniquely comprehensive support for iPS cell-related research. Sigma Life Science acquired a worldwide license to Kyoto University's iPS cell patent portfolio in February.

For more information and to request pricing, visit www.sigma.com/cardiac.

Cautionary Statement: The foregoing release contains forward-looking statements that can be identified by terminology such as "enable," "can identify," "achieve," "predictive" or similar expressions, or by expressed or implied discussions regarding potential future revenues from products derived there from. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that mouse ESC-derived cardiomyocytes or other cell types, iPS cell lines, iPS-cell derived cell types, novel assays, or related custom services will assist the Company to achieve any particular levels of revenue in the future. In particular, management's expectations regarding products associated with mouse ESC-derived cardiomyocytes or other cell types, iPS cell lines, iPS-cell derived cell types, novel assays, or related custom services could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Company's assets and liabilities as recorded in its consolidated balance sheet, and other risks and factors referred to in Sigma-Aldrich's current Form 10-K on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sigma-Aldrich is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sigma Life Science: Sigma Life Science is a Sigma-Aldrich business that represents the Company's leadership in innovative biological products and services for the global life science market and offers an array of biologically-rich products and reagents that researchers use in scientific investigation. Product areas include biomolecules, genomics and functional genomics, cells and cell-based assays, transgenics, protein assays, stem cell research, epigenetics and custom services/oligonucleotides. Sigma Life Science also provides an extensive range of critical bioessentials like biochemicals, antibiotics, buffers, carbohydrates, enzymes, forensic tools, hematology and histology, nucleotides, amino acids and their derivatives, and cell culture media.

About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 35 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich, please visit its website at www.sigma-aldrich.com.

Sigma-Aldrich and Sigma are trademarks of Sigma-Aldrich Co, LLC registered in the US and other countries. CompoZr is a registered trademark of Sigma-Aldrich Co. LLC. SAGEspeed is a trademark of Sigma-Aldrich Co. LLC.

Cor4U and MelCor are registered trademarks of Axiogenesis.

SOURCE Sigma-Aldrich

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