To: Jonathan Schonsheck who wrote (4080 ) 1/15/1999 10:09:00 AM From: Jonathan Schonsheck Read Replies (1) | Respond to of 4342
Overview of the Business Plan (10-KSB) - -------------------------------------------------------------------------------- PRODUCT MARKET NEED ================================================================================ BIOFIT(TM) ESTABLISH A QUALITY QUALITY ASSURANCE ASSURANCE PROGRAM THAT ASSAY SYSTEM HERBAL SUPPLEMENTS CONFIRMS PRODUCT BIOACTIVITY - -------------------------------------------------------------------------------- AH-IMMUNOASSAY(TM) QUICK, INEXPENSIVE FIELD TOXICOLOGICAL SCREENING ENVIRONMENTAL TESTING TEST FOR DIOXIN POLLUTION ASSAY SYSTEM - -------------------------------------------------------------------------------- MORE EFFECTIVE METHOD FOR DRUG SCREENING ASSAY SYSTEM NATURAL PRODUCT DRUG SCREENING NATURAL COMPOUNDS DISCOVERY AND DEVELOPMENT FOR THERAPEUTIC BENEFITS - -------------------------------------------------------------------------------- The herbal supplement market presents the opportunity to commercialize a quality assurance program that identifies the bioactivity present in herbal products, which are complex mixtures of substances. This product is a significant advance versus current practices for verifying the quality and the bioactivity of herbal products. The Company entered into an agreement with R.P. Scherer North America in July 1998 that established R.P. Scherer as the exclusive marketing and distribution agent for Paracelsian's herbal quality assurance product, the BioFIT(TM) Certification program in North America. R.P. Scherer was also granted the worldwide rights to use the BioFIT(TM) program with its soft-gel products in the dietary supplement and OTC markets. R. P. Scherer, a subsidiary of Cardinal Health of St. Louis, MO, is the largest manufacturer of soft-gel capsules for use in the pharmaceutical and dietary supplement industries. The agreement is expected to result in the payment of significant development fees and licensing revenues to the Company in 1999. Within the environmental and toxicological screening markets, the Company is in final negotiations with a large Japanese industrial conglomerate to license the Ah-IMMUNOASSAY(TM) technology for screening dioxin pollution in Japan. The Company anticipates receiving significant revenues from the agreement over the next three years. Within the drug discovery market, the Company has entered into a collaborative research agreement with the Southern Research Institute. Under this agreement, the Southern Research Institute will test a series of the 3<PAGE> Company's TCM herbal extracts for "in vivo" anti-tumor activity against human breast cancer and prostate cancer. The companies will jointly license and market promising products identified in the clinical studies. Until 1998, the Company's strategy was to conduct "in-house" discovery and development of natural drug compounds. The strategy culminated in an attempt to launch a proprietary herbal supplement to enhance the immune system. In late 1997, the FDA ruled that the targeting of the product to those with cancer and HIV made the product a potential drug subject to the testing requirement of new drug compounds. The new management team that was appointed after the January 1998 Biomar capital infusion refocused the Company's business strategy. Current management's priority is to create current income and increase shareholder value by maximizing the revenue potential of the Company's portfolio of patented assay technologies through licensing agreements and joint venture opportunities with outside partners. The Company will still devote resources to the discovery of herbal compounds that have the potential to become patented pharmaceutical products. In 1999, the Company will continue to pursue the following strategies: (i) Identify and develop new markets in industries which will benefit from the adoption of the bioassay testing technologies; (ii) Form co-development and licensing partnerships in these new markets with the industry leaders; (iii) Structure development agreements that will provide up front licensing payments and on-going royalties from partnership revenues; and (iv) Promote the bioassay technologies as the "Industry Benchmark" within these new industries. These strategies will be executed by focusing the Company's primary activities on the following three areas: