Speculative Biotech Firms Grapple With Difficult Approval Process
2011年3月31日 - 9:16PM
Marketwired
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:
www.bedfordreport.com/2011-03-YMI
www.bedfordreport.com/2011-03-PIP
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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YM Biosciences (AMEX:YMI)
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