SOURCE: The Bedford Report

The Bedford Report

May 11, 2011 08:16 ET

Speculative Biotech Firms Battle Poor Success Rates

The Bedford Report Provides Analyst Research on ARIAD Pharmaceuticals & Cyclacel Pharmaceuticals

NEW YORK, NY--(Marketwire - May 11, 2011) - Recent studies have shown that the chances of FDA approval for early stage drugs is dropping significantly, with medication designed to treat cancer being one of the least likely to receive regulatory authorization. Although it remains an exciting time in the biotech sector, with several potential blockbusters working their way through the regulatory process, now more than ever, investors are being urged to use caution. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides research reports on ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC). Access to the full company reports can be found at:

A 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 as likely to gain approval, compared to more traditional chemical drugs. 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.

The study found 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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ARIAD Pharmaceuticals is focused on the discovery, development, and commercialization of small-molecule drugs for the treatment of cancer. Last week the company said t it lost $37.9 million, or 29 cents per share, in the first quarter, compared with a year-ago loss of $23.4 million, or 21 cents per share. Most notably, revenues slipped to $56,000 from $2.2 million due to the restructuring of the company's partnership with Merck to develop and market the potential cancer pill ridaforolimus.

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