SOURCE: The Bedford Report

The Bedford Report

May 13, 2011 08:16 ET

Investors Exercise Caution With Speculative Biotech Firms

The Bedford Report Provides Analyst Research on MannKind & Novavax

NEW YORK, NY--(Marketwire - May 13, 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, many analysts are urging investors to use caution. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides research reports on MannKind Corporation (NYSE: MNKD) and Novavax, Inc. (NASDAQ: NVAX). Access to the full company reports can be found at:

www.bedfordreport.com/2011-05-MNKD
www.bedfordreport.com/2011-050-NVAX

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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MannKind Corporation has been seeking FDA approval for an inhalable form of insulin called Afrezza. Shares of the company were sent plummeting earlier this year after the FDA asked for two new studies of the device in patients with Type 1 and Type 2 diabetes. Alfred Mann -- the company's founder -- was still optimistic and encouraged by the fact the FDA has not asked for anything other than these bridging studies, in terms of clinical work.

The Bedford Report provides Analyst Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned publicly traded companies. The Bedford Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.bedfordreport.com/disclaimer

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