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Market |
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Intec is uniquely poised to provide
a solution to a critical unmet need in the pharmaceutical
industry with its proprietary gastric-retentive drug delivery
platform. Specifically, Intec is positioned to penetrate
two important market segments: the market for narrow absorption
window drugs and for local treatment of gastrointestinal
conditions, such as peptic ulcer disease. Additional potential
markets include the vitamin and supplement and veterinary
drug delivery.
Despite advances made in drug delivery technologies, current
oral drug administration methods have only limited use
for a variety of important drugs with distinct absorption
characteristics. A "narrow absorption window"
characterizes drugs that are selectively absorbed by specific
carriers that exist only in the upper part of the small
intestine. These specific carriers do not exist in the
lower parts of the intestine. Drugs that pass this narrow
absorption window will not be successfully absorbed, thereby
undermining their functionality. In addition, because
excessive doses are administered to compensate for the
narrow absorption window, patients who must take these
oral compounds suffer from a plethora of adverse side
effects.
For many drugs, especially antibiotics, an efficient gastric
retention system would be useful. It would delay gastric
emptying and release the drug at a slower and constant
rate, thereby enabling enhanced absorption and, consequently,
better outcomes.
Intec has identified a pipeline of market-leading drugs
whose efficacy and compliance could be improved substantially
with the application of its controlled-release GRDF platform.
This would deliver higher price performance and increased
sales. Total sales of the drugs in this pipeline totaled
approximately $7 billion in 2000. |
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A better chance for new drug therapies |
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Because of the problem posed by the
narrow absorption window, development on many promising
drug candidates is delayed or even halted completely.
These drug candidates that experience low therapeutic
profile and marketability, and whose development is suspended
in the pre-clinical or clinical trial stage, will benefit
greatly from Intec’s innovative platform, offering a potentially
profitable opportunity to resume R&D, achieve FDA
approval and advance toward full commercialization. |
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Gaining competitive edge |
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Intec’s innovative platform can offer
a product a competitive edge since it results in a more
stable plasma drug concentration and therefore can improve
the efficacy and safety profile of the drug. The drug
levels remain within the therapeutic window and do not
experience the peaks and troughs seen with frequent oral
dosing. If a product can offer a significant improvement
over the competition, then the competitive edge gained
can translate into strong drug sales.
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Challenging the non-compliance
problem |
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Non-compliance costs the healthcare
industry billions of dollars a year. If a drug can be
formulated into a once-daily tablet versus a multi dose
daily therapy, then there is a significantly higher chance
that patients will follow the dosing regimen, leading
to an improved treatment outcome.
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Keeping up with the competition |
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Pharmaceutical companies need to maintain
equality with the competition. In several indication markets,
for example, once-daily dosing schedule is the gold standard,
and any new product reaching the market with a more frequent
dosing schedule is at a significant disadvantage. Therefore,
the GRDF can keep the pharmaceutical company that develops
drug for those indications, up with the competition. |
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Extending the patents on ethical
drugs |
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An innovative delivery form of an
existing molecule can virtually extend patent-life of
an existing ethical drug. Intec's GRDF platform is a new
drug delivery method that meets the prerequisite of offering
a real benefits vis-a-vis existing methods, such as once
a day dosage versus three times daily dosage. This offers
a real competitive advantage over other similar generic
drugs and can extend patent life. |
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Local therapy for gastrointestinal
conditions |
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Intec’s GRDF platform offers an excellent
delivery vehicle for local therapy and absorption for
gastrointestinal conditions, such as peptic ulcer disease.
About 20 million Americans develop at least one ulcer
during their lifetime. Each year, ulcers affect about
4 million people in the U.S. alone. Over 40,000 people
have surgery due to persistent symptoms or problems from
ulcers and an estimated 6,000 people die of ulcer-related
complications. Approximately two-thirds of the world's
population is infected with H. pylori, the bacterial agent
responsible for peptic ulcer disease. H. pylori peptic
ulcers are currently treated with a triple therapy to
kill the bacteria and another drug to reduce stomach acid
and protect the stomach lining. The two-week triple therapy
reduces ulcer symptoms, kills the bacteria, and prevents
ulcer recurrence in over ninety percent of patients.
Many patients find this triple therapy complicated because
it involves taking as many as 20 pills daily. Furthermore,
the antibiotics used in triple therapy may cause mild
side effects such as nausea, vomiting, diarrhea, dark
stools, metallic taste in the mouth, dizziness, headache,
and yeast infections in women. The GRDF platform would
make it possible to deliver localized treatment to the
affected area, while simultaneously reducing the number
of daily doses. With efficacy maintained, patient compliance
would increase significantly, offering an all around superior
treatment modality. |
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