Regulatory Process an Ongoing Challenge for Speculative Biotech Firms

  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 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 Healthcare Sector and provides research reports on Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSSD) and Orexigen Therapeutics, Inc. (NASDAQ: OREX). Access to the full company reports can be found at:

www.bedfordreport.com/2011-02-SNSSD

www.bedfordreport.com/2011-02-OREX

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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Obesity drugs have proven to be one of the most difficult to gain approval. The FDA has proven to be very hesitant to approve prospective obesity drugs due to both safety and efficiency concerns. Earlier this month the FDA dealt Orexigen a blow when the FDA declined to approve its obesity drug, Contrave, in the present form and issued a complete response letter (CRL). The FDA stated that it is concerned about the long-term cardiovascular safety profile of the obesity candidate and has asked Orexigen to conduct an additional study.

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