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Sigma Life Science, the innovative biological products and services research wing of Sigma-Aldrich Corporation (SIAL - Analyst Report), announced the start of a licensing program for contract research organizations (CROs) and pharmaceutical companies. The program is related to its novel CompoZr Transporter Knockout Cell Lines for preclinical ADME screening and safety studies.
Complete functional knockouts of transporters in the intestinal cell line (Caco-2) facilitates critical safety identification and efficacy characteristics compared to current chemical inhibitor-based assays and helps determine a drug candidate's potential drug–drug interactions more precisely. Cyprotex is the first non-exclusive licensee in the program. It is a leading ADME-Tox service company with sites in both the U.K. and U.S.

According to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, a drug candidate's interactions with efflux transporters, which act as escape route for drugs from human cells, helps in determining a drug candidate's probable safety profile and potential for adverse drug–drug interactions.

The present efflux transporter assays use standard chemical inhibitors that can interact with multiple transporters simultaneously. This may produce an ambiguous representation of a drug candidate’s true ADME properties in the human body or potential contradictions with other medications.

Sigma-Aldrich’s CRO and licensing program comply with the new regulatory guidelines and also ensure identification of potential safety issues. For continuing ADME studies in animals, Sprague-Dawley rats containing identical homozygous efflux transporter gene knockouts are also available for purchase from Sigma Advanced Genetic Engineering (SAGE) Labs.

Sigma-Aldrich released its second-quarter 2012 results in July. The company posted adjusted earnings of 97 cents per share for the quarter, in line with the Zacks Consensus Estimate but ahead of the year-ago earnings of 93 cents per share. Profit, as reported, marginally increased year over year to $115 million or 94 cents per share from $113 million or 91 cents per share in the year-ago quarter.

Revenues rose 4% year over year to $664 million in the quarter, aided by acquisitions. The company saw growth across its Research Chemicals and Fine Chemicals (“SAFC”) divisions.

Sigma-Aldrich expects organic growth to be low-to-mid single digits in 2012. Macroeconomic uncertainties may hinder its Research Chemicals business whereas growth in Bioscience and Hitech is expected to drive SAFC sales in the remainder of the year. The acquisitions of BioReliance and Research Organics are expected to boost sales by 6%.

Sigma-Aldrich, a close peer of Bayer AG (BAYRY - Analyst Report), currently maintains a Zacks #2 Rank, which translates into a short-term (1 to 3 months) Buy rating. We have a long-term (more than 6 months) Neutral recommendation on the stock.

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