|
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.
Market
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. 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.
|
