SOURCE: The Bedford Report

The Bedford Report

March 02, 2011 11:25 ET

Oncology Drugs Face Challenging Approval Process

The Bedford Report Provides Analyst Research on Rexahn Pharmaceuticals & AEterna Zentaris

NEW YORK, NY--(Marketwire - March 2, 2011) - 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:

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.

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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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