PAREXEL ENHANCES EARLY PHASE BIOMARKER CAPABILITIES THROUGH ALLIANCE WITH PROTEOME SCIENCES
Boston, MA and Cobham, UK, February 11, 2010 —PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, and Proteome Sciences plc (LSE: PRM), a leading provider of protein biomarker discovery, validation, and assay development services, today announced the formation of an alliance focused on enhancing PAREXEL’s biomarker capabilities for early phase clinical development. PAREXEL is using Proteome Sciences’ PS Biomarker Services™ protein and peptide biomarker capabilities to support biopharmaceutical companies in making earlier assessments of new compounds in development. Proteome Sciences will assist PAREXEL early phase experts in helping biopharmaceutical companies advance biomarker discovery and qualification within clinical trials. This expanded capability allows PAREXEL to offer its customers mass spectrometric and pharmacokinetic assays for protein and peptide compounds.
“Biomarker analyses are anticipated to become increasingly important in clinical trials to understand the biological activity and safety profile of candidate therapies. Our early phase experts are focused on helping customers make better decisions faster about their compounds in development. Biopharmaceutical companies benefit from our bioanalytical and biomarker capabilites to generate reproducible and reliable data that can be interpreted for pharmacokinetic or pharmacodynamic purposes,” said Michelle Middle, MB ChB, Corporate Vice President and Worldwide Head of Early Phase, PAREXEL International. “Our alliance with Proteome Sciences reinforces our commitment to provide customers with significant expertise to help them select relevant biomarkers for their development programs, interpret results, and determine implications for their therapies.”
Christopher Pearce, Chief Executive of Proteome Sciences said: “We are very pleased to have PS Biomarker Services selected by PAREXEL as a preferred provider of protein and peptide biomarker services. We believe that the current regulatory requirements for biomarkers in drug development and diagnostics coupled with the need for fast, flexible and cost effective workflows have meant that specialist services will be increasingly required. Our ISO 9001:2008 facility in Frankfurt, Germany was designed to provide expert protein biomarker discovery and validation and for the development of rapid mass spectrometric-based assays to service the growing requirements of the biopharmaceutical industry.”
PAREXEL early phase experts provide deep scientific insights and a broad portfolio of biomarkers and non-routine laboratory analysis. With its alliance partners, PAREXEL helps biopharmaceutical companies select and interpret the right biomarkers. PAREXEL provides access to key biomarkers in major disease categories, including oncology, hematology, neurology, cardiology, infectious diseases, endocrinology, respiratory, gastroenterology, urology, and immunology. The Company’s early phase units offer fully validated analytical methods, including a broad scope of cellular and soluble biomarker analysis capabilities, and bioanalytical services for qualitative and quantitative drug, metabolite, and biomarker analysis in a variety of matrices.
PAREXEL continuously develops new analytical methods for clients, and has a database with more than 500 internally developed and validated analytical methods, which adhere to ICH and FDA guidelines. PAREXEL’s bioanalytical lab provides routine safety testing and clinical chemistry and hematology analysis. The lab offers state-of-the-art chromatographic systems, including 18 LC-MS/MS instruments for use during PK sample analysis and well-equipped immunochemistry facilities for biomarker analysis. The laboratory has been audited by FDA and WHO among other audits.
PAREXEL’s early phase services provide fully integrated solutions from First in Man through Proof of Concept and help biopharmaceutical companies generate better and faster go/no-go decisions about their compounds, and strive to return solid, reproducible outcomes to succeed in later-phase trials. PAREXEL’s early phase capabilities include a full scope of early phase studies, specialized trial design, state-of-the-art technologies, hospital-based resources, and scientific expertise as well as vast experience in the neurology, cardiology, respiratory, and metabolism/endocrine therapeutic areas. With early phase unit locations across three continents, PAREXEL provides rapid study start-up and access to diverse patient populations in addition to healthy volunteers. For more information about PAREXEL’s early phase capabilities visit: http://www.PAREXEL.com/Early-Phase.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 50 countries around the world, and has approximately 9,200 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings, including the anticipated restructuring charge of approximately $30 million over the second and third quarters of Fiscal Year 2010; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2009 as filed with the SEC on February 5, 2010, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.
About Proteome Sciences
Proteome Sciences, a global leader in applied proteomics, uses high sensitivity proprietary technologies to detect biomarkers. Since its inception in 1994, Proteome Sciences has discovered a large number of novel protein biomarkers in key human diseases. PS Biomarker Services provides ISO 9001: 2008 accredited facilities in Frankfurt, Germany, using proprietary isobaric and isotopic Tandem Mass Tags® (TMT®) to discover protein biomarkers, and reference materials combined with isotope dilution mass spectrometry. Highly multiplexed assays can be developed rapidly and are suitable for screening hundreds of candidate biomarkers in validation studies. Assays for validated biomarkers can be transferred for immunoassay development. Proteome Sciences, based in Cobham, UK, with facilities in London and Frankfurt, delivers outsourced proteomics services and proprietary biomarkers to pharmaceutical, biotechnology and diagnostics companies. The company’s website is: http://www.proteomics.com.