PAREXEL AND PHENOME SCIENCES ESTABLISH COLLABORATIVE AGREEMENT TO INCORPORATE BIOMARKERS IN CLINICAL TRIALS
BOSTON, MA, October 11, 2000 — PAREXEL International Corporation (Nasdaq: PRXL) today announced a collaborative agreement with Phenome Sciences, Inc. for the co-promotion of Metaprobe™ biomarkers for use in clinical research programs. Metaprobe biomarkers provide predictive data on a patient’s potential response to therapeutics. Biomarkers facilitate the clinical trial process by allowing researchers to identify, for a given investigational treatment, the potential side effects, optimal dose, and the individual patients most likely to benefit from it.
Under terms of the agreement, PAREXEL will offer Phenome Sciences’ existing biomarkers and those in development as a component of all appropriate service offerings. Through their combined expertise, PAREXEL and Phenome Sciences will identify opportunities for clients to benefit from incorporating biomarkers into the design and execution of their clinical development programs.
"This agreement reflects PAREXEL’s strategy of partnering with other technology innovators to bring advanced clinical development methods to our clients worldwide," said Josef von Rickenbach, Chairman and CEO of PAREXEL. "Our Scientific and Medical Services (SMS) group continues to adopt new tools to enhance the productivity of the clinical development process."
"In recent years, researchers and drug developers have focused increasing attention on the field of personalized medicine, namely the tailoring of drug treatments to individuals based on their genetic makeup," said Warren Stern, Ph.D., Senior Vice President of PAREXEL’s SMS Unit. "We believe that biomarkers offer an efficient, effective way to incorporate a ‘patient-tailored’ approach to predicting the efficacy or side effect risk for new treatments undergoing clinical study. For example, by selecting the appropriate biomarker, which is tailored to the mechanism of action for the test drug, clinical researchers are able to quantify the magnitude and time course of drug induced changes." Dr. Stern noted also that "Biomarkers can be applied to over 120 functional systems to better determine appropriate dosage and dose frequency for patients receiving medication in clinical trials."
According to Phenome Sciences founder and Chief Scientific Officer, Alfred M. Ajami, Ph.D., "Our dynamic biomarkers allow sponsors to more effectively regulate and tailor drug therapies to specific patient populations. Furthermore, Metaprobe™ technology can be used to confirm a drug’s mechanism of action. This ability to distinguish between multiple potential causes and effects makes our biomarkers a valuable tool in selecting the best candidate molecule for clinical development."
"Other key advantages are that our biomarkers can be safer, less expensive, and faster to implement than predictive tests based on nuclear medicine or genetic profiling," said Peter B. Leone, President and CEO of Phenome Sciences. "For example, a Metaprobe biomarker can measure functional capacity through the easy, non-invasive form of a breath test or minimally-invasive blood plasma test, and have the added convenience of monitoring over time a patient’s response to a drug."
Overview of Phenome Sciences
Phenome Sciences has developed a proprietary methodology to create dynamic biomarkers for drug discovery and development, as well as in silico and chip-based informatics applications. The Company’s Metaprobe biomarkers exploit the established properties of functional systems, which play an important role in disease processes and pharmaceutical effectiveness. Phenotypic variation, a result of differences in our genetic profiles, nutritional habits, and environmental factors, can produce a patient-specific disease risk and response to pharmaceuticals.
Overview of PAREXEL
PAREXEL is one of the largest contract pharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that accelerate time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. The Company’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 43 locations throughout 29 countries around the world, and has approximately 4,200 employees.
Metaprobe is a trademark of Phenome Sciences Inc. PAREXEL is a registered trademark of PAREXEL International Corporation. All other names or marks may be registered trademarks or trademarks of their respective owners and are hereby acknowledged.
This release may contain "forward-looking" statements regarding future results and events, including statements regarding expected financial results, future growth and customer demand that involve a number of risks and uncertainties. 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", and similar expressions are intended to identify forward-looking statements. 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: the cancellation, revision, or delay of contracts, including those contracts in backlog; the Company's dependence on certain industries and clients; the Company's ability to manage growth and its ability to 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; government regulation of certain industries and clients; competition and consolidation within the pharmaceutical 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. These factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Annual Report on Form 10-K for the period ended June 30, 2000.