SOURCE: The Bedford Report

The Bedford Report

March 31, 2011 08:16 ET

Speculative Biotech Firms Grapple With Difficult Approval Process

The Bedford Report Provides Analyst Research on YM BioSciences & PharmAthene

NEW YORK, NY--(Marketwire - March 31, 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 such as YM BioSciences and PharmAthene continue to garner significant attention with potential blockbusters working their way through the regulatory process.The Bedford Report examines the outlook for companies in the Healthcare Sector and provides research reports on YM BioSciences, Inc. (NYSE Amex: YMI) and PharmAthene, Inc (NYSE Amex: PIP). 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 also claims, however, that biotech drugs are twice as likely to gain approval as 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. 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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Data from the study indicates that drugs used to treat cancer are the most difficult to gain approval for, with a small 4.7 percent success rate. YM BioSciences has a drug, Nimotuzumab, in its pipeline that it argues binds to the extracellular region of epithelial growth factor receptor to stop cancer cell proliferation. Nimotuzumab is currently approved for marketing in 25 countries. It is not, however, approved in the US, Canada or Europe.

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