Competition / Competitors
The pharmaceutical and biotechnology industries in which we operate are
characterized by rapidly advancing technologies, intense competition and an
emphasis on proprietary products. Our competitors include large pharmaceutical
and biotechnology companies, specialty pharmaceutical and generic drug
companies, academic institutions, government agencies and research institutions.
All of these competitors currently engage in, have engaged in or may engage in
the future in the development, manufacturing, marketing and commercialization
of new pharmaceuticals and pharmaceuticals, some of which may compete with our
present or future product candidates.
We expect that our product candidates, if approved for marketing, will
compete with existing drugs, therapies, drug delivery systems and technological
approaches, as well as new drugs, therapies, drug delivery systems or
technological approaches that may be developed or commercialized in the future.
Any of these drugs, therapies, systems or approaches may receive government
approval or gain market acceptance more rapidly than our product candidates,
may offer therapeutic or cost advantages over our product candidates or may
cure our targeted diseases or their underlying causes completely. As a result,
our product candidates may become noncompetitive or obsolete.
AI-700, our ultrasound contrast agent for the assessment of myocardial
perfusion, if approved for marketing and sale, will face intense competition.
We believe that ultrasound with AI-700 can be a cost-effective and convenient
substitute for nuclear stress tests, the current standard of care in myocardial
perfusion assessment. In addition, we believe AI-700 will add useful myocardial
perfusion information that stress echo cannot provide without a contrast agent.
Accordingly, we expect to face intense competition from companies that market
products related to these existing imaging techniques, as well as other
companies that are developing ultrasound contrast agents for use in stress echo.
Nuclear stress testing is an established technique for assessing myocardial
perfusion. Radioactive contrast agents that are approved by the FDA for use in
nuclear stress tests include Cardiolite, which is marketed by Bristol-Myers
Squibb Company; Myoview, which is marketed by Amersham plc; and thallium, which
is marketed by Amersham, Bristol-Myers Squibb and Tyco International.
Stress echo without ultrasound contrast is an established technique for
detecting abnormal wall motion, which some cardiologists may find satisfactory
for the detection of coronary artery disease. However, stress echo without
contrast is incapable of assessing myocardial perfusion. We believe that
ultrasound with AI-700 will enable stress echo to provide information on
myocardial perfusion in addition to wall motion.
No ultrasound contrast agent has been approved by the FDA for use in
myocardial perfusion imaging or stress echo. However, we are aware of other
companies that are or may be developing ultrasound contrast agents for use in
stress echo. CardioSphere, which is being developed by POINT Biomedical
Corporation, is an ultrasound contrast agent for the assessment of myocardial
perfusion that is in Phase III clinical trials. In addition, some companies
have ultrasound contrast agents that are FDA approved for resting wall motion
studies or are in development. In the future, these companies may seek to
broaden their indications to include stress echo and myocardial perfusion
assessment. These FDA-approved agents include Optison, which is marketed by
Amersham; Definity, which is marketed by Bristol-Myers Squibb; and Imagent,
which is marketed by Photogen Technologies. SonoVue, which is being developed
by Bracco, is an ultrasound contrast agent which we believe is in late stage
clinical development for detecting abnormal wall motion and for radiology
applications, but as of the date of this prospectus has not received final
approval from the FDA.
AI-850, our reformulation of paclitaxel, if approved for marketing and
sale, will also face intense competition. We are aware of companies, such as
American Pharmaceutical Partners, NeoPharm and Sonus Pharmaceuticals that are
applying significant resources and expertise to developing reformulations of
paclitaxel for intravenous delivery that will compete with our current product
candidate. None of these reformulations have received final approval from the
FDA. Other companies, such as Cell Therapeutics and Protarga are developing new
chemical entities that involve paclitaxel conjugated, or chemically bound, to
another chemical. None of these new chemical entities have received final
approval from the FDA. In addition, a number of companies have developed
technology for delivering hydrophobic drugs. Cardinal Health, CyDex and Elan
have created formulations of hydrophobic drugs that have been approved by the
AI-128, our initial sustained release formulation of an asthma drug, if
approved for marketing and sale, will also face intense competition. Companies
such as Alkermes possess technology suitable for sustained release pulmonary
drug delivery and may have competitive programs that have not been publicly
announced or may decide to begin such programs in the future. We are not aware
of any other company currently in human clinical development of a sustained
release version of the asthma drug that is currently the subject of our
research and development efforts. In addition, many asthma drugs are marketed
by large pharmaceutical companies with much greater resources than us. These
companies may be developing sustained release versions of their asthma drugs
that would compete with our sustained release product candidate.
Many of our competitors in these markets have greater development,
financial, manufacturing, marketing, and sales experience and resources than we
do and we cannot be certain that they will not succeed in developing products
or technologies which will render our technologies and products obsolete or
noncompetitive. We cannot assure you that our products will compete
successfully with these newly emerging technologies. In addition, many of those
competitors have significantly greater experience than we do in their
respective fields. Many of these competitors may have greater name recognition
than we do, and may offer discounts as a competitive tactic.