Sagient Research Reports Significant Decline in FDA Drug Approval Rate
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
-------------------------------------------------
Decision Type 2007 2006 Change
------------- ---- ---- ------
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.
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CONTACT: Sagient Research Systems
Brian M. Overstreet
858-200-2350
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