Investors Hopeful for Blockbusters From Xoma and Amylin
May 11 2011 - 8:16AM
Marketwired
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,
investors are being urged to use caution. The Bedford Report
examines the outlook for companies in the Biotechnology Industry
and provides research reports on Xoma Ltd. (NASDAQ: XOMA) and
Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN). Access to the full
company reports can be found at:
www.bedfordreport.com/2011-05-XOMA
www.bedfordreport.com/2011-05-AMLN
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.
The Bedford Report releases regular market updates on the
Healthcare Sector so investors can stay ahead of the crowd and make
the best investment decisions to maximize their returns. Take a few
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XOMA engages in the discovery, development, and manufacture of
therapeutic antibodies to treat inflammatory, autoimmune,
infectious, and oncological diseases. Last week the company posted
a net loss of $6.3 million, or $0.22 per share, for the first
quarter of 2011, compared with a net loss of $21.8 million, or
$1.36 per share, for the first quarter of 2010.
Last month diabetes drug maker, Amylin posted a loss of $37.3
million, or 26 cents per share, for the quarter ended March 31.
Revenue fell to $152.7 million, from $174.1 million in last year's
first quarter.
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