McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, 101 College Street Suite 406, Toronto ON, M5G 1L7, Canada.
BMC Int Health Hum Rights. 2010 Dec 13;10 Suppl 1(Suppl 1):S11. doi: 10.1186/1472-698X-10-S1-S11.
Developing novel drugs from traditional medicinal knowledge can serve as a means to improve public health. Yet countries in sub-Saharan Africa face barriers in translating traditional medicinal knowledge into commercially viable health products. Barriers in moving along the road towards making a new drug available include insufficient manufacturing capacity; knowledge sharing between scientists and medical healers; regulatory hurdles; quality control issues; pricing and distribution; and lack of financing. The case study method was used to illustrate efforts to overcome these barriers during the development in Nigeria of Niprisan - a novel drug for the treatment of sickle cell anemia, a chronic blood disorder with few effective therapies.
Building on the knowledge of a traditional medicine practitioner, Nigeria's National Institute for Pharmaceutical Research and Development (NIPRD) developed the traditional herbal medicine Niprisan. The commercialization of Niprisan reached a number of commercial milestones, including regulatory approval in Nigeria; securing US-based commercial partner XeChem; demonstrating clinical efficacy and safety; being awarded orphan drug status by the US Food and Drug Administration; and striking important relationships with domestic and international groups. Despite these successes, however, XeChem did not achieve mainstream success for Niprisan in Nigeria or in the United States. A number of reasons, including inconsistent funding and manufacturing and management challenges, have been put forth to explain Niprisan's commercial demise. As of this writing, NIPRD is considering options for another commercial partner to take the drug forward.
Evidence from the Niprisan experience suggests that establishing benefit-sharing agreements, fostering partnerships with established research institutions, improving standardization and quality control, ensuring financial and managerial due diligence, and recruiting entrepreneurial leaders capable of holding dual scientific and business responsibilities should be incorporated into future drug development initiatives based on traditional medicines. Country-level supporting policies and conditions are also important. With more experience and support, and an improved environment for innovation, developing new drugs from traditional medicines may be an attractive approach to addressing diseases in sub-Saharan Africa and other regions.
基于传统医学知识开发新型药物可作为改善公众健康的一种手段。然而，撒哈拉以南非洲国家在将传统医学知识转化为具有商业可行性的健康产品方面面临障碍。在开发新药的过程中存在诸多障碍，包括生产能力不足；科学家与医学治疗师之间的知识共享；监管障碍；质量控制问题；定价与分销；以及资金短缺。本案例研究方法用于说明尼日利亚在开发治疗镰状细胞贫血（一种有效疗法稀少的慢性血液疾病）的新型药物尼普立生过程中为克服这些障碍所做的努力。
尼日利亚国家药物研究所（NIPRD）基于一位传统医学从业者的知识开发了传统草药尼普立生。尼普立生的商业化达成了多个商业里程碑，包括在尼日利亚获得监管批准；与美国商业伙伴XeChem达成合作；证明临床疗效与安全性；被美国食品药品监督管理局授予孤儿药地位；以及与国内外团体建立重要关系。然而，尽管取得了这些成功，XeChem并未使尼普立生在尼日利亚或美国获得主流成功。已提出多种原因来解释尼普立生的商业失败，包括资金不一致以及生产和管理方面的挑战。截至撰写本文时，NIPRD正在考虑选择另一个商业伙伴来推进该药物。
尼普立生的经验证据表明，未来基于传统药物的药物开发举措应纳入建立利益分享协议、与成熟研究机构建立合作关系、提高标准化和质量控制、确保财务和管理尽职调查，以及招募具备科学和商业双重能力的创业型领导者等内容。国家层面的支持政策和条件也很重要。随着经验和支持的增加，以及创新环境的改善，利用传统药物开发新药可能是解决撒哈拉以南非洲和其他地区疾病的一种有吸引力的方法。
