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Growth in Personalized Medicine to Drive Alliances Between Diagnostics and Pharmaceutical Industries, According to PricewaterhouseCoopers
Date:7/30/2009

NEW YORK, July 30 /PRNewswire/ --The growth of personalized medicine, which aims to better target treatments to patients through the use of information about an individual's genes, proteins and environment to prevent, diagnose and treat disease, is expected to increase the number of alliances between diagnostic and pharmaceutical companies, according to a new PricewaterhouseCoopers LLP (PwC) report entitled Diagnostics 2009: Moving towards personalized medicine.

"We expect alliances with the pharmaceutical industry to increase in the next two-to-five years, but this will be driven by factors including the pricing of diagnostics, the extent of reimbursement coverage, and the burden of any clinical validation work required for market access," said Gerald McDougall, principal, health sciences practice, PricewaterhouseCoopers.

The report highlights the prominence of personalized medicine in current merger and acquisition (M&A) and licensing deal activity in the in vitro diagnostics (IVD) sector. In 2008, personalized medicine motivated three of the 10 largest M&A deals and four of the licensing deals by the 10 largest IVD companies.

According to the report, a number of factors are expected to drive the continued development of personalized medicine and why diagnostics will become more important, including:

  • Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA), which are supporting the field of personalized medicine by introducing formal requirements to test for certain biomarkers prior to prescribing certain drugs.

  • Legislation introduced in May 2008 in the United States and Europe to protect individuals against discrimination resulting from the use of genetic information may now encourage more people to undergo genetic testing or participate in innovative research.

  • Genentech's Citizen Petition of December 2008, which created new momentum around the discussion of the diversity of regulatory paths to market for in vitro diagnostics.

  • The formal adoption of new diagnostic technologies in the guidelines of important clinical communities, which should accelerate their market adoption. Agendia's MammaPrint (a DNA-based test for evaluating an individual's risk of breast cancer spreading to other sites) is an example of a new diagnostic tool to help personalize treatment, which was recently validated by a national clinical group in the Netherlands - the Dutch Institute for Healthcare Improvement.

Although the effort to better personalize treatments is not new, significant further progress is needed because current patient response rates to medicines can be very low - varying from 20 percent to 75 percent depending on the drug. Pressure from healthcare payers is putting more emphasis on the availability of a companion biomarker test when deciding on a drug's reimbursement, says PricewaterhouseCoopers. Companion diagnostics are diagnostic tests designed to guide the prescribing of a specific drug by assessing a patient's risk of adverse events or likelihood of therapeutic effectiveness when taking this drug.

"Increasingly, pharmaceutical companies will not move a drug candidate to the clinical development stage without a clear biomarker development program," added McDougall. "These companies understand the contribution of biomarkers and diagnostics in improving the design and probability of success of clinical trials. These factors will combine to accelerate the development of new diagnostics for personalized medicine. Together we anticipate that alliances and collaboration will be inevitable as the market need expands."

A full copy of the report is available at www.pwc.com/diagnosticsandpersonalizedRx.

About PricewaterhouseCoopers

PricewaterhouseCoopers (www.pwc.com) provides industry-focused assurance, tax and advisory services to build public trust and enhance value for its clients and their stakeholders. More than 155,000 people in 153 countries across our network share their thinking, experience and solutions to develop fresh perspectives and practical advice.

"PricewaterhouseCoopers" refers to PricewaterhouseCoopers LLP or as the context requires, the PricewaterhouseCoopers global network of other member firms of the network, each of which is a separate and independent legal entity.

((C) )2009 PricewaterhouseCoopers LLP. All rights reserved

Note to editors:

1. Biomarker: Any biological information, which may be used as an indicator for a particular condition. A biomarker could be, for example, the concentration of a particular protein in someone's blood or the occurrence of a particular variant of a gene.

2. In vitro diagnostics: Diagnostic devices to perform tests outside the body, for example in a test tube. By contrast, in vivo diagnostics perform tests inside the living body, as for example in medical imaging. In vivo diagnostics industries are not reviewed in this report.


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SOURCE PricewaterhouseCoopers
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