[Ip-health] BIO Study: e overall success rate from Phase I to FDA approval is nearly 10%

Jamie Love james.love at keionline.org
Fri Jan 10 10:56:22 PST 2014

This is a release published by BIO on Thursday.  Jamie


New Study Shows the Rate of Drug Approvals Lower than Previously Reported

JANUARY 9, 2014
Contact: Daniel Seaton
Phone: 202-470-5207
Email: dseaton at bio.org

New Study Shows the Rate of Drug Approvals Lower than Previously Reported

Washington, D.C. (January 9, 2014) – Today, Nature Biotechnology published
a peer-reviewed paper co-authored by the Biotechnology Industry
Organization (BIO) Industry Analysis and BioMedTracker (BMT) highlighting
results of a study showing that the overall success rate for drugs moving
through clinical trials to FDA approval from late 2003 to the end of 2011
is near one in 10. Previous reports, taken from earlier years, showed the
rate of drug approvals is one in five to one in six.

“This groundbreaking study highlights the depth and breadth of risk
inherent in the drug development process more comprehensively than any
other previous study,” said Dave Thomas, Director of Industry and Research
Analysis at BIO and one of the paper’s lead authors. “Knowing more about
the magnitude of risk can lead to smarter drug development as well as
smarter investing.”

The study builds on the findings from previous studies and uses a broader,
deeper, and larger sample than previous reviews of clinical trials and
approvals data using the BioMedTracker (BMT) proprietary database of close
to4,500 drugs and over 7,300 unique development paths.

"Having an up-to-date and detailed picture of clinical success rates, and
ultimately how likely a drug is to be approved, is vital to our clients
when making investment and business decisions.  We believe that this study
provides the market with an accurate and comprehensive picture of the
relative difficulty of achieving product approval in the U.S.," remarked
Michael Hay, Executive Vice President at Sagient Research.  "Strikingly,
oncology drugs have the toughest time making their way through the clinic,
despite cancer being the most closely studied area in drug development. We
are very pleased to be able to offer this analysis and provide an in-depth
look at the issues facing the industry that lead to these lower rates."

Using clinical trial data from the past nine years, the analysis examines
the most recent probability of success by treatment type, phase of
development and therapeutic area.  Before new therapies hit the market,
they have to pass a number of hurdles – meeting regulatory thresholds for
efficacy and safety as well as maintaining a competitive internal corporate
profitability and marketability profile.

Key findings from the study include:

*  The overall success rate from Phase I to FDA approval is nearly 10%.
This number is comprised of lead and secondary indications.

*  The study also shows that large molecule drugs are twice as successful
in gaining approval compared to small molecule drugs.

The BMT/BIO study examines the clinical Phase status of these development
paths as of year-end 2003 through year-end 2011, which accounts for more
than 5,800 Phase transitions.  The study determines the percentage of drugs
that advance to the next Phase of development versus those that are
suspended and therefore the likelihood of a drug ultimately being approved
by the FDA.  The data spans all companies (Big Pharma and biotechnology,
both public and private) conducting development on therapeutics for
approval in the U.S.

The BMT/BIO analysis includes breakdowns by indication, disease group, size
of company, molecule type, route of administration, New Molecular Entity
(NME) versus Biologic versus non-NME.  The data encompasses the most recent
data available during a time in which FDA requirements for approval have
been in flux.  Included in the analysis is an in-depth look at FDA
decisions and approval rates by FDA review number.

The paper is available to Nature Biotechnology subscribers.

James Love.  Knowledge Ecology International
http://www.keionline.org, KEI DC tel: +1.202.332.2670, US Mobile:
+1.202.361.3040, Geneva Mobile: +41.76.413.6584,   twitter.com/jamie_love

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