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VOLUME
02:
ISSUE 6
Health Is Wealth
It's PARTY time! 2002 is expected
to be the coming out party for the biotech sector. The fruits of innovative
research performed in the past few years will propel a new pipeline of
drugs to reach the market. This means that many small companies may be
potentially sitting on drugs or therapies that could generate billions
in sales and profits. The success of Genentech in the 80's helped inflate
a biotech bubble that eventually imploded in the late 80's and early 90's.
However, the trickle down effect produced a new breed of scientist/entrepreneur.
These future biotech CEOs realized that they could go off on their own
to pursue research without the bureaucracy that often plagues large corporations
and academic institutions. Moreover, the prospect of amassing vast
personal wealth also played a part. These above factors are the driving
forces that are fueling the current biotech sprint.
The new paradigm has shifted from
internet/technology companies to biotech. This is where the next major
area of expansion will be. Even the Nasdaq 100 (QQQ)
has
expelled some of its most high profile tech names in favor
of biotech companies.
Our lives in the next few decades
will be touched by the biotech industry more than any other. Thousands
of new jobs will be created, and as technology and biotechnology start
converging to one, the next great industry will be born. Ultimately,
for mankind, illnesses that were once thought to be fatal and incurable
will soon become treatable with simple, effective, and advanced procedures.
This is not only welcome news for the sick and the dying, but also for
investors who are smart enough to cash in on all the progress leading to
this evolutionary panacea.
During the entire 10 year period
between 1976 and 1985, the FDA approved only 198 new drugs. In 2001 alone,
the number of new drug approvals skyrocketed to 160. That figure is expected
to climb even higher in 2002. At present, an astonishing 643 new pharmaceuticals
are
nearing the final stages of the FDA's testing and approval process, according
to a recent report prepared for the US Department of Health and Human
Services.
Many investors are already well aware
of the coming biotech boom. The question is separating the contenders from
the pretenders. Nonetheless, judging from the recent rise in key biotech
stock indexes, investors are banking on biotechs, hoping that they'll generate
whopping returns reminiscent of those investors pocketed from once hot
tech stocks such as Cisco (CSCO)
, Microsoft (MSFT)
and other tech stalwarts. Such hopes are not entirely misplaced.
There will indeed be companies that will develop and commercialize drugs/applications
with billion dollar potential.
Developing new pharmaceutical compounds
is costly and time consuming. Yet the rewards can be enormous, both for
the companies involved and for their investors. Before new pharmaceuticals
can be sold, they must successfully complete three phases of testing as
mandated by the FDA. This process can take as long as 15 years, although
expedited procedures enacted during the Clinton administration have reduced
the testing period in some cases to less than five years.
The earlier a new drug is in the
development process, the higher the risk the drug does not ever reach the
market. According to Tricia Nagle, managing editor of the newsletter Drug
and Market Development, more than 90 percent of all new biopharmaceuticals
under development never even make it to the first part of Phase III trials.
If a company is fortunate enough to reach Phase III testing, it is still
not a guarantee of success. It is estimated that roughly 40 percent of
potential new drugs fail their final phase III tests.
The following are biotech companies
with applications that have the potential to make big splashes in 2002.
ViroPharma (VPHM):
Cure
for the common cold. The company's future rests on Picovir,
the magic cold treatment. ViroPharma filed its New Drug Application (NDA)
with the FDA for US approval of Picovir on July 31st, and it was accepted
for review on October 1st. With an anticipated FDA review time of
12 months, we expect the company to hear back from the FDA July 31, 2002,
with a final approval anticipated by the end of the third quarter. This
is your typical "grand slam" or perishes type of biotech company.
Maxim Pharmaceuticals (MAXM):
Cancer
Treatment. Ceplene?, is currently being tested in Phase III
cancer clinical trials in 12 countries for malignant melanoma and acute
myelogenous leukemia, and in Phase II trials for the treatment of hepatitis
C and renal cell carcinoma. Phase III clinical trials for Ceplene
,
the treatment of advanced metastatic melanoma, is expected to begin 1Q/02.
Maxim will also be advancing its hepatitis C infection program with a Phase
II trial in 2002.
Medarex (MEDX):
Cancer
Treatment & Arthritis. Medarex utilizes its own patented
UltiMAb-Mouse
system to create fully human antibodies for itself and others, offering
a full range of antibody development and manufacturing capabilities.
15 UltiMAb-derived antibodies are expected to be in the clinic by the end
of this year. Collaboration agreements with 10 new partners should be initiated
during 2002. Phase III trials were recently started on MDX-CD4
a treatment for rheumatoid arthritis. MDX-010 is currently undergoing
several multi center Phase I/II trials in prostate cancer, melanoma and
other malignancies.
MDX-210
is being evaluated in patients
with solid tumors.
MDX-33 is currently being tested in patients
with the auto immune disease ITP.
Axcan Pharma (AXCA):
Gastrointestinal Treatment & Cancer.
Axcan
is a leading specialty pharmaceutical company within the field of gastroenterology
in North America and Europe. Key products including
ULTRASE for
pancreatic enzyme replacement,
PHOTOFRIN
photodynamic therapy for
lung and esophageal cancer and
CANASA rectal suppository for inflammatory
bowel disease. Helicide, Axcan's patented, oral, single capsule,
triple therapy treatment for H. Pylori infection (the leading cause of
peptic ulcers and a potential cause of gastric cancer) should be FDA approved
later this year. It's good to know someone is fighting our gastro
problems.
DUSA Pharmaceuticals (DUSA):
Cancer
Detection. The company's main product Levulan® PDT/PD is
a platform used for the detection and treatment of a variety of superficial
conditions, such as early cancers, pre cancers and skin conditions.
Levulan apparently has wider applications and may add to the bottom line
in the not too distant future. DUSA initiated three Phase I/II Levulan
PDT clinical trials. In dermatology, in co-operation with Schering AG,
Germany, trials are now well underway in onychomycosis (nail fungus) and
warts, joining the already ongoing study in acne. Initial results from
all of these studies are expected during early to mid 2002.
Investing in the biotech world is more
interesting and fruitful than any other sector. Biotech investors
most often seek to find the company with the cure for something.
The companies mentioned above are on the "application side", where returns
are much higher, although accompanied with the downside of greater risk.
In addition, most biotechs show little or no revenue, and almost all in
a sea of red ink. However, finding "the one" will lead to the kind
of home run that each investor only dreams about. The monetary gains are
quite substantial but so are the potential losses if something goes awry.
Just look at Imclone (IMCL)
-
a perfect example of what happens when a dream turns to a nightmare.
But much like the internet/technology
sector, there are two types of companies. First, we mentioned the
application companies which are often too risky for many investors.
The second type of company is on the infrastructure side, usually referred
to as the "picks and shovels". These biotechs are the suppliers and
drivers to the application companies. This relationship is similar
to how Cisco (CSCO)
and Oracle (ORCL)
has
helped power all the Webvans and eToys of the world.
Infrastructure companies often have
real revenues and earnings derived from supplying application companies.
Owning stock in infrastructure companies helps diversify much of the downside
risk because there are so many startups aiming to develop that billion
dollar cure. They will spend millions on goods and services which in turn,
allow the infrastructure companies to build their war chest of cash for
use in getting into the application side of the business in the future,
creating a biotech behemoth.
Any company can wake up one day and
decide to find a cure for any disease, but trying to become an infrastructure
company is very difficult because of the barriers to entry.
Now the burning question is who are these "picks and shovels" companies?
The SmallCap Digest has discovered
a biotech company that fits the bill. We will be bringing you more information
on this company very soon. Once we have conducted a complete due
diligence on this company we will inform our subscribers of the findings.
Stay Tuned!
D I S C
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