SAN DIEGO, Jan. 9, 2008 (PRIME NEWSWIRE) -- Sagient Research Systems, a leading publisher of independent research for the financial services and institutional investment communities, today issued a research report documenting a significant decline in FDA Drug Approvals in 2007. According to its biotechnology research service BioMedTracker, the FDA's drug approval rate declined 13% in 2007 while the rate of approvable letters issued increased by 40% and non-approvable letters increased by 22%. An approvable letter is issued when additional data is required before the FDA will approve a new drug. It is viewed as a negative event since it requires a delay in the approval process. According to Sagient's volatility event tracking service, CatalystTracker, the average absolute stock price change resulting from an approvable letter issuance dropped to 12.89% in 2007 from 21.42% in 2006.
BioMedTracker is an institutional research service that identifies and analyzes investment opportunities in the biotech and pharmaceutical sector. BioMedTracker analyzes clinical trial data and the regulatory history of each drug in development to assess its overall likelihood of approval by the FDA. CatalystTracker, the newest addition to Sagient Research's product offerings, provides the only comprehensive method to track upcoming volatility events for public companies.
Commenting on the report of FDA drug approval rates, Michael Hay, Senior Analyst and Product Manager for BioMedTracker said, "The FDA has received a lot of criticism over several high profile adverse events cases including Vioxx, Tysabri and Avandia. This has triggered an overly cautious approach to new drug approvals at the FDA. Other potential reasons for the decline in approval rates cited in our report include an increase in adverse event reports, increased workload for FDA employees, and a high rate of turnover at the FDA. The decrease in the average price changes following an approvable letter may be directly linked to institutional investors' lower expectations that the FDA will in fact approve drugs. It has become less of a surprise when a new drug is given an approvable or an outright non-approvable letter. If the trend holds true through 2008 we may see a paradigm shift in the way institutions approach FDA decision events in the biotech and pharmaceutical sectors."
For 2008, CatalystTracker expects 68 decisions on NDA/BLA's and 41 decisions on Supplemental Applications. An NDA is a New Drug Application. A BLA is a New Biologics Applications. Both are vehicles through which drug sponsors formally propose that the FDA approve a new drug or biologic. Supplemental Applications formally propose that the FDA allow the drug or biologic expanded use.
Percentage Change in FDA Decisions: 2006 vs. 2007
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Decision Type 2007 2006 Change
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Approved 64% 73% -13%
Approvable Letter 28% 20% 40%
Non-Approvable 8% 6% 22%
BioMedTracker's biomedical investment information can be accessed online with a paid subscription via www.BioMedTracker.com.
CatalystTracker's dynamically updating upcoming catalyst calendar can be accessed online with a paid subscription via www.CatalystTracker.com.
To arrange for a demonstration of BioMedTracker and CatalystTracker, or to obtain a copy of FDA Approval Report, please send an inquiry to BioMedSubscribe@sagientresearch.com or CatalystSubscribe@sagientresearch.com.
About Sagient Research Systems
Sagient Research Systems is a publisher of independent research. We develop, produce, and sell proprietary research products to mutual funds, hedge funds, and investment banks. Our business strategy is to continue to leverage our development, technology, and marketing expertise to solidify our position as a leading provider of independent research to the financial services and institutional investment communities. In September 2007, Sagient Research was named to the inaugural Inc. 5000 list of fastest growing companies. For more information, please visit the Sagient Research Systems website at www.sagientresearch.com.