Quotient Announces the First Use of ivMicrotracer to Support a Regulatory Drug Approval Submission

Quotient Clinical

announced that absolute bioavailability data from an

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MicrotracerTM study has been used to support a submission for regulatory drug approval. The study was performed on behalf of Bristol Myers Squibb in support of OnglyzaTM (saxagliptin), a new medicine for Type 2 Diabetes.

Data generated in the study were included in regulatory filings to the Australian Therapeutic Goods Administration (TGA) which has resulted in drug approval.

Applying

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Microtracer techniques in clinical studies allows intravenous PK and absolute bioavailability data to be generated within five months and at a fraction of the cost compared to traditional approaches.  In addition,

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Microtracer techniques can be used in stand-alone studies, or integrated into any standard early development study, maximising the flexibility for generating these data.

Mark Egerton, MD of Quotient Clinical, commented:  “We are delighted to have supported Bristol Myers Squibb on this study.

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Microtracer is a standard component of our development “toolbox,” allowing us to efficiently generate key supporting pharmacokinetic data sets for drug development teams.”