Our Business Strategy
Lower cost anti-viral drugs for treatment of hepatitis are needed to slow the growing epidemic of hepatitis C (HCV) infections which cause over 75%-80% of liver disease around the world. Ribavirin and interferon-alpha (especially pegylated interferon-alpha) are the mainstays of anti-viral therapy against HCV, but these drugs are unaffordable by most patients infected with the virus, costing several thousands of dollars per month for up to 48 months of therapy. Cyplasin Biomedical plans to have the active ingredients manufactured for the Company by "off-shore" suppliers that comply with FDA and European regulatory processes. The regulatory approvals for marketing our own branded anti-viral drug products will occur within 6-12 months of the regulatory submissions in countries such as Brazil, Mexico and Argentina and within 12-18 months in countries like the U.S. and the countries of the European Union. The Company's growing revenue base from near-term sales of anti-viral drugs will be used to fuel our preventative vaccine development program, and to investigate new and better anti-viral therapies.
During the initial phases of operations, in order to save money and time, the Company intends to outsource GMP production, clinical trials management, and global regulatory submissions to contract research organizations (CROs). The Company will enlist a contract marketing and sales organization (CSO) with
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experience in the anti-viral market to launch and sell our anti-viral products once approved by the regulatory authorities. The Company will contract with research labs at NIH and elsewhere to continue to support anti-viral drug and vaccine development.
The Company's near-term plans are to submit market applications in multiple countries for the Company's anti-viral drugs and complete Phase I safety, immunology & efficacy studies of the HCV vaccine in humans, thus creating value by achieving major developmental milestones in the next 18-24 months - revenue generation from the sales of anti-viral drugs, and proof in humans that VLP vaccine immunization leads to development of neutralizing antibodies that attack the HCV virus and prevent infection. Based on our ability to attract a corporate partner and/or raise money in the private and public markets, Cyplasin Biomedical will continue to advance the development of other anti-viral pipeline products and we plan to begin Phase II efficacy studies of the VLP vaccine as a potential anti-viral immunotherapy for treating chronic HCV infection. An antibody product derived from healthy volunteers administered VLP vaccine inoculations will be evaluated as a passive immunotherapy product in patients undergoing liver transplantation to prevent or significantly delay the liver graft re-infection by the hepatitis C virus. |
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