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 CritiTech
conducts business in the arena of chemical particle
size reduction. The company's strength derives from
a patent portfolio licensed from the University of Kansas,
from the respected reputation of its founders and advisors
in their scientific and professional fields, and from
the business experience of its management and Board
of Directors.
CritiTech's technology
is helpful to the pharmaceutical industry in that we
use the fine-particle approach to:
- help solve drug delivery problems;
- extend patent life through re-formulation
based upon fine-particle platform;
- pulmonary or inhaled delivery;
- ease of handling of high-potency APIs;
- potential to coat implantable devices;
- stabilizing biomolecules through SCF
drying
I -Opportunities to Enhance Value
for Currently Marketed Products:
A- Use of Drug Delivery
Systems
A growing number of pharmaceutical companies
are now applying the technologies of drug-delivery companies
to enhance the convenience, safety, and efficacy of
currently marketed products. When successful, the approach
of adding value to established products can yield substantial
commercial success.
B
- Increasing Patent Life of Existing Drugs
There are literally
hundreds of case studies showing that revenues from
a drug can decrease by 70% upon patent expiration. At
that time, these "off-patent" drugs become
open to attack from competitors who produce and sell
generic drugs for a fraction of their brand name cost.
Patent expirations in the coming year will cost the
brand name pharmaceutical manufacturers an estimated
$20 billion. This results in significant lost revenues
for pharmaceutical companies, who typically commercialize
2-3 new products per year. Since these companies strive
to maintain a 10-15% earnings growth, management of
older drug products becomes crucial.
Application of a drug delivery technology
to compounds about to go off-patent can potentially
create a 'new' drug that would be independently patentable
and could extend a company's monopoly on the existing
compound for another seventeen (17) to twenty (20) years.
This would allow pharmaceutical companies to cost-effectively
increase the life cycle of a drug beyond its normal
life period. CritiTech's technology can allow companies
to "recompound" old drugs to allow for sustained
release formulations or new routes of administration,
potentially adding safety and efficacy benefits to older
compounds, extending patent life, and enhancing patient
benefit.
II. Improving
the likelihood of development success for new compounds
and novel agents:
A-Water Solubility
Problems
It is estimated that between 30-40%
of all new chemical entities produced by pharmaceutical
companies have water-solubility problems that make these
compounds unusable as drugs. To address this problem,
companies often employ complex strategies to increase
water solubility, such as using excipients, co-solvents
(alcohol or detergents), prodrug formulations, or combining
drugs with a carrier molecule. While in most cases,
the first strategy is to try and reduce particle size,
size reduction technologies prior to CritiTech's technology
produced uneven results.
The appeal of improving aqueous solubility
via reduction of the size of the drug particle lies
in its simplicity. Particle size reduction results in
increasing the effective surface area of the compound,
thus enhancing its dissolution rate. Until recently,
however, standard-milling processes could reduce particle
size somewhat, but the resulting particles were still
relatively large (>50 micrometers) with broad size
distribution. Thus, although milled particles of this
size do have some improved dissolution rates, many compounds
remain insoluble due to their inherent chemical properties
and the tendency of some particles to agglomerate into
larger less effective particle sizes after the milling
process has been completed. The CritiTech process avoids
all of these problems through its patented technologies
that result in the production of extremely small particles
of uniform size.
B-Protein
and Peptide Drug Delivery Problems
Biotechnology drugs (protein and peptide drugs
such as insulin, growth hormone, and (-interferon) present
a different delivery problem. These drugs are generally
water-soluble, but are not deliverable by oral methods
because they are sensitive to enzymes in the digestive
system. Such drugs show promise of efficient delivery
by the pulmonary route, using inhalation or transdermal
therapy yet again; particle size is a major challenge.
CritiTech has already applied its technology successfully
to 2 proteins, albumin and insulin, forming soluble
nanoparticles of both proteins.
III.
Improve effectiveness of a drug and/or device through
coating:
Through the Company’s process it becomes
possible to coat materials (both a device and a pharmaceutical
compound) with nanoparticles.
A - Coating Devices:
The Company has successfully completed the
initial phases of a project with a major manufacturer
of cardiac stents to coat these stents with nanoparticulate
immunosuppressant. Each year, more than 900,000 heart
patients nationwide undergo angioplasties –procedures
in which doctors use tiny balloons to clear obstructed
heart arteries and insert stents to keep the vessel
open. But in 20 - 30% of patients, scar tissue forms
to re-clog the cleared vessel, causing severe chest
pain, shortness of breath, difficulty walking and in
many cases requires a new surgery. Doctors and analysts
say that stents coated with immunosuppressive drugs
in order to block the growth of scar tissue can help
lower these rates to 5% or lower . Industry analysts
estimate that the stent market, currently $ 2.3 billion,
could easily double in size in the next three to four
years as clinicians convert to coated stents that will
fetch a hefty premium over bare metal stents.
B
- Coating Pharmaceutical Compounds:
CritiTech has developed the process to
coat pharmaceutical compounds and is working with a
major pharmaceutical company on this application. The
largest markets for such a process are in taste masking
drugs for the pediatric market and timed release of
drugs into the body. More recently CritiTech has used
its coating technology to further develop the ease of
handling of high potency APIs.
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