Institute for One World Health
Working for the Food and Drug Administration in the early 1990s, Victoria Hale saw many promising new medicines abandoned or not developed to their full market potential. Diseases such as visceral leishmaniasis, long ignored and often fatal, needed special and urgent attention. In 2000 she founded the Institute for OneWorld Health to address the gap between global infectious diseases and pharmaceutical opportunities. Victoria has since left and founded a new nonprofit pharmaceutical company, Medicines360, focusing on unmet needs of the world’s women and children. It is a self-sustaining social enterprise, founded with philanthropy, driven by global health inequity, and sustained by revenues. Initial focus areas are contraception and neglected/orphan diseases.
In December 2011, OneWorld Health became an affiliate of PATH, an international nonprofit organization that saves lives and improves health, especially among women and children. The two organizations share a commitment to advancing health technologies to reach those most in need and a focus on diseases that disproportionately impact developing countries, including malaria, diarrheal disease, and HIV. The affiliation allows OneWorld Health to scale and accelerate its successful drug development efforts, and offers new opportunities to pursue integrated strategies that support its longstanding commitment to reducing the toll of urgent global health problems. Now as PATH’s Drug Development program, the team continues its work to develop and ensure availability and accessibility of safe and effective new medicines for diseases disproportionately affecting people in developing countries. Learn more here: http://sites.path.org/drugdevelopment/
- In partnership with the World Health Organization (WHO), iOWH has developed Paromomycin IM Injection as a safe, effective, affordable treatment for visceral leishmaniasis. Having received Indian regulatory approval after a series of clinical trials with over 1000 patients in Bihar, this success is being expanded into Bangladesh and Nepal. Paromomycin IM Injection has been included on the WHO’s Model List for Essential Medicines.
- A unique partnership coordinated by iOWH is pioneering the use of synthetic biology to produce a reliable supply of artemesinin, an key component of treatment for malaria, at an affordable price. PMIM is registered with the National Drug Development agencies of India (2006), Nepal (2012), and Uganda (2012), and is included on WHO’s Essential Medicine List.
- Semisynthetic artemisinin – a new source of malaria treatment
- In 2004, we launched a public-private partnership to develop a new pharmaceutical manufacturing process to produce commercial volumes of high-quality, non-seasonal, and affordable artemisinin to supplement the plant-based supply.
- Large-scale production of semisynthetic artemisinin was launched in 2013, with Sanofi’s production capacity of 50 to 60 tons per year, corresponding to approximately 30-40% of the global demand for artemisinin.
- Semisynthetic artemisinin is produced using a no-profit, no-loss pricing model. The current cost of semisynthetic artemisinin, from $380 to $475 per kilogram, is comparable to the historical average cost of high-quality, botanical production.
- Semisynthetic artemisinin and Sanofi’s artemisinin derivative—artesunate—received prequalification from WHO in May 2013. This decision minimizes the regulatory burden on manufacturers who plan to use it in their products, offering a clear path to a stronger artemisinin supply chain worldwide.
- Sanofi began first delivery of large-scale batches of antimalarial medication (ASAQ) manufactured with a new semisynthetic artemisinin derivative to malaria endemic countries in Africa in August 2014, marking the entry of the final product made with a new ingredient to the global market.
- Semisynthetic artemisinin offers a potential to strengthen the artemisinin supply chain, stabilize pricing, and ultimately ensure the availability of treatment to millions suffering from malaria.
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