Lots Of Biotech Opportunities This Week…Here Are A Few

This
week and next could prove to be very busy
for stocks in the biotech
sector, for two reasons. As I mentioned
in my last
article
, on May 15 a FDA Advisory Panel will decide the fate of the drug
Xolair, a new approach to the treatment of asthma in adolescents and adults.
Three companies are developing the drug: 
Tanox
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, Genentech
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, and Novartis
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.
The Panel’s meeting on Thursday has all the earmarking of a volatile
trading period, before and after the decision.

Xolair is a novel drug that has
the potential to impact on the treatment of a large disease market.
A positive panel recommendation would go a long way to improving the
financial future of all three companies involved.
A negative recommendation would be a significant setback.
Interestingly enough, Xolair falls in the drug class of monoclonal
antibody. If the FDA Advisory Panel does
vote for a positive recommendation, this may validate other companies that
specialize in monoclonal antibody development. Some
of these other monoclonal antibody companies include Protein
Design Labs

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, Medarex
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,
and Abgenix
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.In addition to the FDA’s
action in midweek, this weekend will signal the beginning of a popular medical
meeting bringing together international specialists in treating diseases of the
gastrointestinal tract. From May 17-22,
gastroenterologists will gather in Orlando, Fla., for the annual meeting of the
American Gastroenterological Association. This
meeting is commonly called Digestive Disease Week.
At this high-profile gathering, the latest research on such big disease
markets as colorectal cancer, inflammatory bowel disease, hepatitis, pancreatic
cancer, and biliary tract disease will be discussed. 

There are many companies with a
presence at this meeting, using it as a forum to present new scientific and
clinical data. One company that seems to
have a significant presence is an Israeli biotech that trades on the Nasdaq.
Given Imaging
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has developed a cutting-edge technology called Capsule Endoscopy.
The company has developed a tiny miniature video camera inside a
disposable capsule. The M2A capsule is
the only non-invasive way to look inside the small intestine, traditionally a
difficult organ to diagnostically evaluate. Here
the buzz phrase is non-invasive.
Any potential new technology that can replace an invasive procedure or
operation will always get the attention of physicians and investors.

A patient suspected of having a
medical problem originating in the small intestine (such as occult bleeding or a
tumor) can swallow this miniature capsule. As
this device passes through the entire digestive tract, high-resolution images
are taken and transmitted to a small receiver outside the body.
Once these images are downloaded, a physician has a unique look inside
the lumen of the small intestine. The FDA
approved the use of this device in August 2001 and doctors are warming up to its
potential benefits in diagnosing diseases of the gastrointestinal tract.
The company expects to get a fair amount of attention from many of its
presentations at this year’s Digestive Disease Week. 

Given Imaging recently releases
its quarterly earnings and experienced a 65% increase in revenue from the
previous quarter (down from the 100% previously projected).
Given Imaging now projects 50% revenue growth for the year and expects to
become profitable next year.  

EXACT
Sciences

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is also scheduled to
make several presentations at the annual meeting of American Gastroenterological
Association during Digestive Disease Week. This
company has developed a non-invasive DNA-based
test
(PreGen-Plus) for the early detection of colorectal cancer.
Colorectal cancer affects over 150,000 patients annually and is the
second leading cause of cancer deaths in the United States.

The
standard screening tests today range from the very inaccurate, least invasive
(occult fecal blood testing) to the very invasive, very accurate (colonoscopy).
EXACT Sciences has developed a simple test designed to detect the
genetically abnormal cells in the stool of patients with colorectal cancer
cells. The test was developed with the
best minds at Johns Hopkins University and was recently approved by the FDA.
It should be commercially available by mid-year.
The PreGen-Plus stool test is more accurate than current non-invasive
testing for colorectal cancer and should be warmly received by physicians.
The company also hopes to adapt this DNA-based technology for the testing
of other cancers as it goes forward. As a
physician who operates on many patients with colorectal cancer, I welcome an
improvement on the current screening methods available to physicians. 


Good
Luck,



Paul
Ruggieri, MD, FACS