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R&D productivity worse than previously reported

Published on 15/02/11 at 10:29am

A new analysis of pharma’s R&D pipelines suggests the overall success rate for drugs moving from clinical trials to FDA approval is nearly just one in 10.

The study conducted by the US Biotechnology Industry Organization (BIO) and BioMedTracker (BMT) covers a period from late 2003 to the end of 2010, and suggests overall productivity has declined even further than feared.

Analysis looking at productivity from earlier years, showed the rate of drug approvals as 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 Alan Eisenberg, executive vice president of emerging companies and business development at BIO. “Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing.”

The analysis builds on the findings from previous studies and uses a larger sample than previous reviews of clinical trials and approvals data, using the BioMedTracker (BMT) proprietary database of 4,500 drugs and over 8,000 unique development paths.

The study’s release coincides with the 13th Annual BIO CEO & Investor Conference in New York.

"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 US," remarked Michael Hay, senior biotechnology analyst at BMT.  "Strikingly, oncology drugs have the toughest time making their way through the clinic, despite cancer being the most closely studied area in drug development.” 

Using clinical trial data from the past seven years, the analysis examines the most recent probability of success by treatment type, phase of development and therapeutic area.  

A number of factors play a role in the failure of drug candidates - regulatory thresholds for efficacy and safety, internal corporate profitability and marketability profile – and many of these tests have become more stringent in recent years.

Key findings from the study include:

• Overall success rates from phase I to FDA approval is nearly nine per cent. This number is comprised of lead and secondary indications. When separated, lead indications have close to a one in seven rate of approval and secondary indications have a rate of one in 30.

• Clinical trials that address secondary indications for drugs tend to be far less successful on average. This was seen in all phases of clinical development as well as in all disease areas.

• The study also shows that large molecule drugs are twice as successful in gaining approval than small molecule drugs.

Andrew McConaghie

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