Sagient Research Publishes Updated Report on FDA Approval Rates

* Reuters is not responsible for the content in this press release.

Tue Apr 6, 2010 8:02am EDT

SAN DIEGO, April 6, 2010 (GLOBE NEWSWIRE) -- Sagient Research Systems, a leading
publisher of independent research for the financial services, institutional
investment and corporate intelligence communities, recently published an updated
report analyzing approval rates at the U.S Food and Drug Administration (FDA).
According to its research service, BioMedTracker, the rate of drugs that were
approved by the FDA in 2008 and 2009 has remained close to the historical low
seen in 2007. The report also examined the role FDAAA legislation, enacted in
2007, has played in the FDA not reaching its PDUFA goals. In addition, the
report analyzed the impact advisory panels have on FDA decisions, approval
timelines for drugs receiving Risk Evaluation and Mitigation Strategy (REMS)
programs, and stock price movements around PDUFA dates. The report mentioned
several high profile FDA decisions expected in 2010, including Dendreon's
Provenge for prostate cancer, InterMune's Esbriet for idiopathic pulmonary
fibrosis (IPF), and Vivus' Qnexa for obesity.

BioMedTracker is an independent research service that offers proprietary
clinical assessments and patient-based revenue forecasts of developmental drugs
within a comprehensive and intuitive drug information database. Clients from the
pharmaceutical, biotech, and investment industries rely on BioMedTracker for its
insight on the likelihood of approval, commercial potential, and future data and
regulatory catalysts for drugs within the competitive landscape of every
important disease and indication. CatalystTracker is the most efficient method
to track upcoming volatility events for public companies. Catalysts are
constantly updated by Sagient's in-house analyst team and presented to clients
online in an easy to use, searchable, and customizable format.

Commenting on the report of FDA Approval Rates, Michael Hay, Senior Analyst and
Product Manager for BioMedTracker said, "Despite an increase in the overall
number of drugs being approved since the low seen in 2007, the overall rate of
approvals has remained depressed as compared to 2006. Increased responsibilities
and authorities granted to the FDA under FDAAA have created new dynamics to the
approval process, such as the need for REMS programs. This has led to extended
approval timelines and it is important for the industry to analyze and implement
all the elements needed for approval early in the drug development process." Hay
continued, "In 2009 we saw striking Phase III data from companies such as
Dendreon and Vivus. In 2010 that data will lead to some exciting FDA decisions.
We eagerly await what is again sure to be a thrilling and volatile year for
companies navigating the FDA."


           BioMedTracker FDA Approval Rates: 2006-2009           
  -------------------------------------------------------------- 

  Decision Type          2009       2008       2007       2006   
  ------------------  ---------  ---------  ---------  --------- 

  Approved               64%        67%        63%        73%    
  ------------------  ---------  ---------  ---------  --------- 

  Not-Approved           36%        33%        37%        27%    
  ------------------  ---------  ---------  ---------  --------- 

BioMedTracker's powerful biomedical investment information can be accessed
online with a paid subscription via www.BioMedTracker.com.

CatalystTracker's dynamic updating upcoming catalyst calendar can be accessed
online with a paid subscription via www.CatalystTracker.com.

Sagient's product portfolio also includes PlacementTracker, a dynamic,
customizable research service that provides clients with market data, research,
and analysis on the PIPE (Private Investment in Public Equity) market. This data
can be accessed online with a paid subscription via www.PlacementTracker.com.

To arrange for a demonstration of BioMedTracker and CatalystTracker, or to
obtain a copy of FDA Report Update, please send an inquiry to
BioMedSubscribe@sagientresearch.com or CatalystSubscribe@sagientresearch.com.

About Sagient Research Systems

Sagient Research Systems is a publisher of specialized research and data. We
develop, produce, and sell proprietary research products to global enterprises,
including investment banks, mutual and hedge funds, pharmaceutical companies,
academic institutions, and government agencies. 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.

In each of 2007, 2008 and 2009 Sagient Research was recognized by Inc. Magazine
as one of the 5000 fastest-growing private companies in America. For more
information, please visit the Sagient Research Systems website at
www.sagientresearch.com.

The Sagient Research Systems logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7294

CONTACT:  Sagient Research Systems
          Bobbi Sue Richardson
          858-200-2390
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.