| The industry in which the Company competes is characterized by extensive
research and development efforts and rapid technological progress. New
developments occur and are expected to continue to occur at a rapid pace, and there can be no assurance that discoveries or commercial developments by the Company's competitors will not render some or all of the Company's potential products obsolete or non-competitive, which would have a material adverse effect on the Company's business, financial condition and results of
operations. The Company's competitive position also depends on its ability to attract and retain qualified scientific and other personnel, develop effective proprietary products, implement development and marketing plans, obtain patent protection and secure adequate capital resources. In the fields of cancer therapy and the prevention of precancerous and cancerous lesions, other products are being developed that may compete directly with the products that the Company is seeking to develop and market.
The Company is aware of clinical trials in which a number of pharmaceutical
and nutritional agents are being examined for their potential usefulness in
the treatment of precancerous lesions and cancer. These include studies of
NSAID-like compounds, cyclooxygenase inhibitors, difluoromethylornithine
("DFMO") and natural nutrients in the treatment of APC and sporadic colonic
polyps, studies of retinoids and DFMO in the treatment of cervical dysplasia
and studies of tamoxifen for the prevention of breast cancer. Additional
compounds being tested in various epithelial lesions include compounds related to aspirin, various vitamins and nutritional supplements, oltipraz, N-acetyl cysteine and compounds that interfere with hormone activities. The studies are being conducted by pharmaceutical and biotechnology companies, major academic institutions and government agencies. There are other agents, including certain prescription drugs, that have been observed to have an effect on ARE. Although the Company is not aware that any third party has demonstrated the preclinical utility of these compounds in the treatment of precancerous or cancerous lesions, there can be no assurance that such existing or new agents will not ultimately be found to be useful, and therefore competitive with any future products of the Company. Near-term competition from fully integrated and more established pharmaceutical and biotechnology companies is expected. Most of these companies have substantially greater financial, research and development, manufacturing and marketing experience and resources than the Company and represent substantial long-term competition for the Company. Such companies
may succeed in discovering and developing pharmaceutical products more rapidly than the Company or pharmaceutical products that are safer, more effective or less costly than any that may be developed by the Company. Such companies also may be more successful than the Company in production and marketing. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and established biotechnology companies. Academic institutions, governmental agencies and other public and private research organizations also conduct clinical trials, seek patent protection and establish collaborative arrangements for the development of oncology products. CPI will face competition based on product efficacy and safety, the timing and scope of regulatory approvals, availability of supply, marketing and sales
capability, reimbursement coverage, price and patent position. There can be no assurance that the Company's competitors will not develop more safe and
effective products or obtain patent protection or intellectual property rights
that limit the Company's ability to commercialize products that may be
developed or commercialize products earlier than the Company. There can be no assurance that the Company's issued patents or pending patent applications, if issued, will not be challenged, invalidated or circumvented or that the rights granted thereunder will provide proprietary protection or competitive advantage to the Company. |