SOURCE: The Bedford Report

The Bedford Report

March 31, 2011 08:16 ET

Speculative Healthcare Firms Struggle to Get Blockbuster Drugs Approved

The Bedford Report Provides Analyst Research on Opko Health & Dendreon

NEW YORK, NY--(Marketwire - March 31, 2011) - There is plenty of optimism surrounding the healthcare sector as firmer pricing and new products have improved sales and earnings trends. Meanwhile, younger, more speculative firms continue to garner significant attention with potential blockbuster products working their way through the regulatory process. The Bedford Report examines the outlook for companies in the Healthcare Sector and provides research reports on Opko Health, Inc. (NYSE Amex: OPK) and Dendreon Corporation (NASDAQ: DNDN). Access to the full company reports can be found at:

A recent study released by BIO and BioMed Tracker 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. Last month Opko Health purchased the early-stage biotech company, CURNA for $10 million. CURNA uses a medical technology platform based on regulating protein production and is focusing on whether this method could develop treatments for cancer, diabetes, cardiovascular disease, paralysis, wound healing and neurological diseases.

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