
| Company Strategies The growing interest in “Natural Medicine” is justified by many health benefits seen in traditional herbal medicine uses, and also by the recognition of the scientific community that the plant genome offers exciting opportunities for discovery in today’s new therapeutic agents. Recently, FDA released regulations of the Dietary Supplement Act which allows for greater flexibility in making claims for medicinal plant products. In responding to the growing consumer interest in “Alternative Medicine” and new FDA regulations, NPI is dedicated to the development of ‘natural medicine” or “prescription botanicals” selected from traditional Chinese medicine based on its proven clinical efficacy. NPI believes that this ethnobotany based approach coupled with modern drug screening capabilities and sophisticated analytical technologies offers the best chance not only to discover new drug candidates derived from natural products but also to develop scientifically evidenced alternative herbal therapies to meet the healthcare challenge of the 21st century. The natural medicine developed at NPI will be marketed under its own brand name as the best quality controlled and scientifically studied natural remedies. Discovery of New Drug Candidates from Herbal Medicines NPI is a high-tech drug discovery and development company located in Burlington, Massachusetts. In the past 15 years, NPI has established strong collaborations with several prominent universities and research institutions in the United States and in China and has successfully produced several drug candidates by screening medicinal plants used in China for millennia. For instance, NPI-BC-4-1, a potent topoisomerase I inhibitor and cell differentiation inducer, was isolated and identified as a potential anti-cancer agent for prostate and brain tumors. This anticancer activity has been verified by the National Cancer Institute (NCI) in its human tumor cell line panels and by a clinical trial in Germany. Recent work on the development of an herbal suppressor of alcohol drinking resulted in the discovery of NPI-031G as a potential anti-craving agent for the treatment of alcoholism, a major social and health problem in the U.S. and around the world. NPI-031G showed higher efficacy than naltrexone in high alcohol drinking rats and monkeys. Naltrexone is the only drug approved by the FDA for the treatment of alcoholism in the U.S. Acceptance by patients has been poor because of the potential for liver damage. Development of Natural Remedies Parallel to its activities in the discovery of potential new drug candidates from traditional herbal medicines, NPI is also dedicated to the development of “natural remedies” called “botanicals” by the FDA, into prescription medicines. NPI has several natural remedies on the market. The first product, called “Hui-Chun,” is derived from a traditional Chinese anti-aging medicine. Two other products are based on DHA (docosahexaenoic acid) derived from deep-sea fish. DHA is an essential nutritional component for optimum brain and eye function and is good for the circulatory system. In addition to its DHA product for adults, NPI developed a unique refined DHA nutritional supplement for infants and children that is free from fish odor. This pediatric DHA product was approved by the equivalent of the FDA in China and is being actively marketed in Beijing, China. Because of China’s one-child policy and its huge population, this product has great commercial potential. Recently, NPI obtained one additional natural remedy (kazoom: liver protection ) approved by China FDA. |