SOURCE: The Bedford Report

The Bedford Report

March 14, 2011 07:35 ET

Geron and MannKind Brace for Increased FDA Scrutiny

The Bedford Report Provides Analyst Research on Geron & MannKind

NEW YORK, NY--(Marketwire - March 14, 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 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 Geron Corporation (NASDAQ: GERN) and MannKind Corporation (NASDAQ: MNKD). 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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Regulatory approval of drugs is a process that frequently comes under fire for being too rapid or too slow. The FDA has reacted to long standing criticism by streamlining some of its guidelines and procedure. Europe's EMEA has largely resisted expediting its approval process. A recent study suggested that the European drug approval system takes twice as long to approve cancer drugs than does the FDA, adding fuel to recent criticism of the European drug approval process.

California-based MannKind Corp 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.

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