POTENTIAL MARKET FOR ORAL PEPTIDE DRUGS
April, 2005.

Protein drugs represent one of the areas of fastest growth within
pharmaceuticals. From literally zero sales a decade ago, there are now
multiple blockbuster protein drugs. Driving the growth are a number of new
drugs, which are markedly superior to existing small-molecule drugs. While
protein-based therapeutics can be remarkably more expensive than
traditional small-molecule drugs (for example, the widely used TNF-alpha
inhibitors cost over $10,000 per patient per year), patients, doctors and
insurers all agree that the new therapies are superior to their cheaper
predecessors. In addition, many biologics can treat diseases, which are
untouched by small-molecule drugs.

According to a soon-to-be-released updated report from Business
Communications Company, Inc. (www.bccresearch.com)  RC-065U The
Market for Bioengineered Protein Drugs, in 2002, drug companies sold nearly
$33 billion in protein drugs, and we project they will sell close to $40 billion in
2003.

We predict that sales of these drugs will continue to grow faster than
pharmaceutical's overall historic growth rate of 8% annually. The market for
protein drugs will grow at an AAGR (average annual growth rate) of 12.2%
from 2003 through 2008 to reach nearly $71 billion. Several important new
drugs should receive FDA approval for sale, and previously introduced
biologics will continue to strip market share from older, less effective
therapies. Most notably, there are a number of monoclonal antibodies in the
last stages of clinical trials for the treatment of autoimmune disease and
cancer that promise to be blockbusters.

While growth of protein drugs should be healthy, industry participants in the
market also face serious and new challenges. Notably, lawmakers are
threatening to introduce bills governing the introduction of generic drugs, and
several leading drugs will lose their patent protection within the timeframe of
this study. This would be historically important, since there are neither generic
protein drugs currently on the market, nor is there any framework for the
introduction of generic protein drugs.

At the same time, the drug-discovery process has been turned upside down
through the use of technologies such as high-throughput screening,
genomics, proteomics, rational drug design and other technologies. In
particular, the immune system is one of the most complex systems known to
man; these new technologies are revealing hundreds of possible targets for
the treatment of immune disease.

While all medicines in existence are aimed at one of 500 targets, one can
conservatively estimate that there are between 3,000 and 10,000 possible
targets based on the estimated number of proteins. Many of these new
targets represent excellent opportunities for the development of protein drugs.

These new technologies are just starting to affect the drug industry. As a
result, over the next 5 years the amount of money the pharmaceutical industry
devotes to product development will rise sharply; the number of drugs brought
to market will start to rise, but not proportionately.


Worldwide Sales of Protein Drugs, through 2008
($ Millions)
                             2002   2003    2008      AAGR % 2003-2008
Replacement proteins         26,711 31,423  50,091       9.8
Aantibodies fus proteins     6,226   8,478  20,860      19.7
Total                                    32,937 39,901  70,951     12.2

Source: BCC, Inc.


The global sales for pharmaceutical products have reached 267 billion
dollars, and the sales for North America are 149 billion dollars in 2001.
Among these products, protein and peptide drugs are the most growing
segments with total wordwide sales exceeding $18 billion in 2001.  

OPPORTUNITIES WITH THE PROTEIN BASED DRUGS

Protein and peptide drugs ("protein drugs" hereafter) have been the most
rapidly growing segments of the prescription drug market in the last a few
years. There are currently 14 or more protein drugs (not including
macromolecules such as vaccines and antibodies) on the market with total
worldwide sales exceeding $18 billion in 2001. More than 250 protein drugs
are in clinical studies worldwide. Protein drugs cannot be taken by oral
means in their native form because they are rapidly broken down by
enzymmes in the gastric-intestinal tract into inactive pieces. Protein drugs to
date have, therefore, been confined to injection rather than the more
convenient and high compliance oral tablets and capsules.

A few major players in the development of oral protein drug products are
indentified. Their techniques are very unique, including bioadesive tablets,
oral sprayers, colonic drug delivery systems, oral nanoparticles etc. And, most
of them are developing oral drug products of calcitonin, LHRH, human-growth
hormone, insulin, and certain interferons.

                                    
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POTENTIAL MARKET FOR ORAL
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