Diaceutics Identifies Critical Market Drivers for Personalized Medicine Development

Special Report Details Business and Market Issues Facing Drug-Makers Seeking to Maximize ROI for Targeted Drugs and Associated Diagnostics

WASHINGTON, DC--(Marketwire - January 27, 2010) - Traditional models for predicting marketplace potential for "one-size-fits-all" drugs are inadequate for the new world of personalized medicine in which developers of targeted therapies hope to follow in the footsteps of successful drugs, such as Genentech's Herceptin® or Tarceva®, according to the authors of a special report in the current issue of Personalized Medicine (Vol. 7, Issue 1, 2010, pp.103-114).

The report describes why conventional financial models for predicting net present value (NPV) and return on investment (ROI) for traditional drugs don't work for development of targeted therapies. Currently, pharmaceutical development teams lack financial benchmarks needed to understand how targeted therapies and related diagnostics will perform in the emerging personalized medicine marketplace -- with a potential value of $245 billion, by some estimates.

Personalized medicine involves diagnostic testing to identify a patient's or a disease's specific genetic makeup and the use of this information to identify the most appropriate therapy for that patient.

"Typically, executives fail to understand that targeted therapies and associated tests are fundamentally different products from one-size-fits-all drugs," said Peter Keeling, chief executive officer of Diaceutics and a co-author of the report. "Targeted drugs and stand-alone tests do not behave in the market in the same way as one-size-fits-all drugs or diagnostic tests."

According to Keeling, pharmaceutical development teams have yet to establish a financial model that enables them to maximize NPV and ROI for targeted drug therapies that rely on a companion diagnostic test. In fact, the authors estimate that Herceptin, as successful as it was, lost an additional $3 billion in revenue as a result of a poorly executed companion diagnostic strategy.

"Assuming that the economics of a targeted therapy are the same as other drugs is a dangerous premise that has not proven itself in actual development," said Keeling. "Better market models are essential as estimates indicate that 25% to 50% of future drug launches will be based on personalized medicine."

The report describes Diaceutics' Case-Based Reasoning Financial Benchmarking Model™ an interactive, evidence-based benchmarking and financial tool that identifies what drivers will be most effective for ensuring successful development and marketing of a unique targeted therapy.

The Model is based on an examination of over 200 cases in which a drug therapy and a diagnostic test have interacted (negatively or positively) in the marketplace. (Case-based reasoning uses real-world cases from which reasonable analogies may be drawn to identify factors similar to a study problem, such as introducing a targeted therapy.) It has uncovered 10 critical drivers likely to impact targeted drug therapy's market success and revenue stream:

--  Optimized R&D investment
--  Value-based pricing 
--  Early revenue capture 
--  Rate of prescription (Rx) adoption 
--  Marketplace differentiation
--  Rate of and propensity to prescribe
--  Patient compliance
--  Ability to extend life-cycle
--  Rx-risk associated cost avoidance
--  Rate of diagnostic adoption

In the process of validating these drivers against targeted therapies already on the market for infectious diseases and oncology, the authors found it likely that only three to four of the 10 drivers will be critical for any single development project.

"Our financial modeling shows that when a drug-maker allocates appropriate resources to the key drivers, they can capture market share earlier in the adoption process and increase overall ROI," said Keeling.

The Model was first developed in 2005 through a study analyzing how a companion diagnostic for a rheumatoid arthritis drug could be used to reshape that drug's existing one-size-fits-all therapeutic market. Initially, 53 cases or "analogs" were used in the study.

When these initial findings were applied to five rheumatoid arthritis drugs available at the time of the study, it was determined that a companion diagnostic -- if used effectively to shape the therapeutic market -- could produce an additional 17.5% in NPV.

"It's already difficult for the pharma and diagnostic industries to bridge their cultural, strategic and scientific differences," said Keeling, "but an effective financial modeling tool enables both sides to recognize potential ROI and the value of collaboration."

Co-authors of the Personalized Medicine special report were Mollie Roth, Diaceutics' corporate counsel and vice president of business development, and Dave Smart, PhD, senior advisor to Diaceutics. The full text of the article can be purchased at http://www.futuremedicine.com/toc/pme/7/1.

Diaceutics (www.diaceutics.com) provides pharmaceutical industry leaders with the foundation and operational structure needed to effectively develop and commercialize targeted therapies to better meet patients' needs and to improve overall return on investment. Diaceutics is an international change management and consulting firm specializing in personalized medicine with a mission to build bridges between pharmaceutical and diagnostic players.

Contact Information: Contact: Mollie Roth, Esq. Corporate Counsel, VP of Business Development 202-280-5887