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Avoiding No Man's Land: New Deloitte Study on Follow-on Biologics Investigates Proposed Legislation and Possible Unintended Consequences
Date:4/14/2009

ly on those drugs that promise huge returns on investment. To recoup the amount of time and money an innovator spends on a new drug, experts have shown that to break even, a drug would have to achieve annual revenue of roughly $150 million, which is impossible unless a drug targets a large population, or charges a high price per treatment. This blockbuster effect has led pharma companies generally to focus development efforts on only the largest potential indications.

  • "No Man's Land" effect: As soon as a company receives a patent for a compound, the clock for commercialization begins ticking. Each year a patented drug spends in development is another year of lost revenue. If enough time elapses, there comes a point where the compound will never be able to earn sufficient return on investment. This could lead to promising compounds being dropped from development, including those for critical diseases like cancer, Parkinson's, Alzheimer's and others, because there is no way to fund the research once the compound has crossed into this "no man's land." Deloitte estimates this can occur within as little as one year of achieving a patent.

According to Hollingshead, "The most serious of these unintended consequences may be the 'no man's land effect,' which could substantially reduce the biotech industry's ability to continue to develop innovative treatments for our most pressing diseases and medical conditions."

Because of the structural differences between the pharmaceutical industry of 1984 and today's biotech industry, Congress will need to act with care as it looks to create a regulatory path for FOBs.

To view the entire paper, visit www.deloitte.com/us/FOB.

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