Oncology Drugs Face Challenging Approval Process
March 02 2011 - 11:25AM
Marketwired
There is plenty of optimism surrounding the Biotech industry as
firmer pricing and new products have improved sales and earnings
trends. Meanwhile, younger, more speculative biotech firms such as
Rexahn Pharmaceuticals and AEterna Zentaris continue to garner
significant attention with potential blockbuster drugs working
their way through the regulatory process. The Bedford Report
examines the outlook for companies in the Biotechnology Industry
and provides research reports on Rexahn Pharmaceuticals, Inc. (NYSE
Amex: RNN) and AEterna Zentaris, Inc. (NASDAQ: AEZS). Access to the
full company reports can be found at:
www.bedfordreport.com/2011-03-RNN
www.bedfordreport.com/2011-03-AEZS
A recent study released by BIO and BioMedTracker claims that the
success rate in bringing new medicines to market in the past six
years is only about half of what it had been previously. The study
claims, however that biotech drugs are twice more likely to gain
approval than more traditional chemical drugs.
The study finds that drugs moving from early stage Phase I
clinical trials to FDA approval is roughly ten percent, down from
around 20 percent in reports involving earlier years.The report
adds that approval applications were filed for 55 percent of the
drugs that made it to Phase III testing, and 80 percent of those
gained eventual approval -- though only half were approved on
initial review.
The Bedford Report releases regular market updates on the
Biotechnology Industry so investors can stay ahead of the crowd and
make the best investment decisions to maximize their returns. Take
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The study also finds that that drugs used to treat cancer are
the most difficult to gain approval, with a small 4.7 percent
success rate.
AEterna Zentaris operates as a late-stage drug development
company specialized in oncology and endocrinology. AEterna Zentaris
already markets Cetrotide, a luteinizing hormone-releasing hormone
antagonist treatment approved for in vitro fertilization.
Rexahn Pharmaceuticals is developing and seeking to deliver
cures for cancer and disorders of the central nervous system. On
Monday the company said that it has been granted a European patent
for its anti-cancer compounds.
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