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



9/6/2011 11:30:44 AM

September 06, 2011 -- Quotient Clinical, a business unit of Quotient Bioresearch (Quotient), today announced that absolute bioavailability data from an ivMicrotracerTM 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.

Results from the study were recently presented at the 12th Annual Land O’Lakes Bioanalytical Conference: Agency and Industry Perspectives on Biomarkers, Bloodspots and Beyond (Merrimac, WI July 11-15, 2011)1. Data generated in the study were included in regulatory filings to the Australian Therapeutic Goods Administration (TGA) which has resulted in drug approval2.

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

For more information on Quotient Clinical, please call +44 (0)115 974 9000, email clinical@quotientbioresearch.com or visit www.quotientbioresearch.com/clinical.

For further information, please contact:

Chrissie Walker or Emilie Whelan

bcsAgency

Tel: 0115 9486900

Email: quotient@bcsAgency.com

References

1: Achieving Regulatory Approval: Overcoming Bioanalytical Challenges in an Onglyza® Micro-tracer Absolute Bioavailability Study with Accelerator Mass Spectrometry, Xiaohui (Sophia) Xu et al, Research & Development, Bristol-Myers Squibb, Lawrenceville,NJ, USA (July 2011)

2: Australian Public Assessment Report for Saxagliptin Hydrochloride, Proprietary Product Name: Onglyza, Submission No: PM-2008-03469-3-5, Sponsor: Bristol-Myers Squibb Australia Pty Ltd (April 2011)

About Quotient Clinical

Quotient Clinical is a leading provider of early development services. Its Translational Pharmaceutics™ platform offers a unique and streamlined process to reduce the time from First-in-Human studies to Proof-of-Concept by integrating flexible drug product manufacture into clinical trials

Drug product formulations can be efficiently optimised for downstream development using the RapidFACT™ service (Rapid Formulation development And Clinical Testing) in a process that significantly shortens timelines and saves significant money.

14C clinical studies can be provided as a fully integrated service using the flexible Synthesis-to-Clinic™ platform. Synthesis-to-Clinic enables all the processes involving 14C drug products, from synthesis of the 14C labelled drug molecule through to conduct of human clinical trials, to be undertaken with a single vendor and a single project manager throughout, delivering significant time and cost savings.

With a strong customer base across the United States, Europe and Japan, the goal of Quotient Clinical is to provide a unique and comprehensive range of early development services to pharmaceutical and biotechnology customers.

Quotient Clinical is a business unit of Quotient Bioresearch.

About Quotient Bioresearch

Quotient Bioresearch is a leading provider of early stage and specialist drug development services to life science clients worldwide. We provide tailored solutions for pharmaceutical, biotechnology and agrochemical clients, using state-of-the-art technologies underpinned by unparalleled medical, chemical and biological expertise. Our consultative, science-driven approach ensures the highest quality service to support and accelerate the development of your products. Our extensive range of capabilities spans Chemistry and Metabolism, Bioanalytical Sciences, and Clinical. These can be provided independently or integrated into bespoke work programmes.

For further information: www.quotientbiroesearch.com.

Becky Anderton Account Executive

email: becky@bcsagency.com

telephone: +44 (0)115 948 6900

web: www.bcsagency.com

LinkedIn: www.linkedin.com/in/beckyanderton


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