Mobilizing Science-Based Enterprises for Energy, Water, and Medicines in Nigeria (2007) / Chapter Skim
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Appendix C: Artemisinin-Based Malaria Therapy: Hypothetical Case Study
Appendix C: Artemisinin-Based Malaria Therapy: Hypothetical Case Study
Pages 108-128
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From page 108... ...
At present, no company is engaged in all these activities, although there are companies, some of which participated in the meeting, that do produce other antimalarials and have some experience with artemisinins. Participants in the workshop included persons associated with the University of Ibadan, University of Calabar, XeChem Inc., Neimeth International Pharmaceuticals, the Drugs for Neglected Diseases Initiative, Médicins sans Frontières, and Office Technique d'Études et de Coopération Internationales, Paris (OTECI)
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From page 109... ...
This uncertainty is, in fact, part of the landscape that must be negotiated in the real world. THE uSE OF ARTEMISININ DERIVATIVES Artemisinin, the active ingredient extracted from the leaves of the Artemisia annua plant, has been used for centuries in Chinese traditional medicine to treat fever.
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From page 110... ...
Nigeria has adopted Coartem as the first-line treatment for uncomplicated malaria, but most people in Nigeria, like those in the rest of Africa, are still using the older, cheaper drugs. Coartem sells for a wholesale price of $2.40 per adult course and about $20 retail in the pharmacy.
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From page 111... ...
The production and distribution of ACTs encompass several different processes, and it is unlikely, and perhaps not economically feasible, that a single company would carry out all of the tasks and functions involved. However, because the interactions among several partners, if there were such an arrangement, would be a relatively simple part of the establishment of the enterprise, it was convenient to consider the hypothetical enterprise to be a single company that carries out all functions, including production of the artemisinin derivatives through collaboration with an advanced laboratory.
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From page 112... ...
annua in Nigeria • the local extraction and purification of artemisinin • the production of artemisinin derivatives in collaboration with advanced laboratories • the local manufacture of ACTs that are globally competitive using current Good Manufacturing Practices (cGMPs)
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From page 113... ...
In the most extreme case, funds may be used to import and distribute ACTs at no charge or for a nominal price through public sector institutions, which might seriously distort an incipient ACT market for local producers. (The government has already announced a program of free ACTs for schoolchildren.)
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From page 114... ...
Once Nigerian companies obtain WHO's cGMP certification, they may be able to serve the large market in other countries of West Africa as well. The Nigerian pharmaceutical industry includes several companies that claim the capability to achieve cGMP certification for ACTs.
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From page 115... ...
Instead of trying to compete in the entire production process, the Company could elect to master steps one by one. Because producing a reliable crop of artemisia and extracting the derivative may take a long time, it might be most advantageous to concentrate on the formulation and local marketing of the medicine using imported derivative.
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From page 116... ...
annua and producing artemisinin, funding is needed to pay for seeds, to pay farmers for their harvests or field workers to cultivate Company-owned lands, and to pay for drying the leaves and extracting and then purifying the artemisinin. Possible sources of funding are venture capital, banks, individual investors, and government investment in return for equity in the Company.
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From page 117... ...
But in Brazil, India, Nigeria, and other tropical countries, the combination of high light intensity and no cold season would allow two or more harvests a year for many cultivars. In experience reported from India, a first harvest produced 25 kilograms of artemisinin per hectare, but harvesting leaves after four months while leaving the stems in the field and again harvesting two months later resulted in three or four separate harvests yielding a total of 75 kilograms of artemisinin per hectare.
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From page 118... ...
The process of extracting artemisinin requires precision in harvest timing and subsequent processing. The plants are not permitted to flower, because, once they do, the artemisinin content drops, and the seeds spread weedy plants that may be difficult to control.
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From page 119... ...
Source: "Summary of Working Group B: Artemisinin Extraction, Storage and Quality Assurance," Meeting on the Production of Artemisinin and Artemisinin-Based Combination Therapies, Arusha, Tanzania, June 6–7, 2005, convened by Roll Back Malaria Department, World Health Organization, http://www.who.int/malaria/docs/arusha-artemisininmeeting.pdf. small holdings, and small holders must work through cooperatives or be able to benefit from government procurement in order to make economic use of mechanization.
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From page 120... ...
Impurities can be removed and the crystals vacuum dried to produce pure crystalline artemisinin. In Nigeria, the solvent must be imported.
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From page 121... ...
The offer includes another small factory to produce an artemisinin derivative in order to enter the Nigerian market. The demand in Nigeria is about 20 tons, grown on 2,000 hectares, and one extraction plant in one location should be sufficient to start.
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From page 122... ...
It should be possible for a company to operate under cGMP conditions certified by WHO, thereby allowing the product to be sold in Nigeria and other countries willing to accept the import. But without prequalification, the product would not be eligible for international purchase (e.g., using funds from WHO or the Global Fund)
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From page 123... ...
It could be placed near the cultivators, in a city such as Calabar, but that location would mean incurring extra transportation cost to Lagos, the major commercial center in Nigeria where most of the pharmaceutical companies are located. Calabar does, however, offer the possibility of support from the state government.
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From page 124... ...
It is quite likely that an established pharmaceutical company would play a large role in the manufacture of ACTs, whether as a partner of a new company or as the prime entity that will subcontract the growing of artemisia and the extraction of artemisinin. The established company would likely have to dedicate some of its own capital to the venture in order to qualify for financing from a commercial bank or an international financing agency such as the African Development Bank or the International Finance Corporation.
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From page 125... ...
This process would require a V blender with a capacity of 5 cubic feet for a 30–50 kilogram batch, at an approximate cost $25,000 for used and $50,000 for new; and a capsulefilling machine at a cost of $30,000 used and $50,000 new for a table-top model with a capacity of 20,000 capsules per hour, or $65,000 used and $110,000 new for a floor model with a capacity of 40,000 capsules per hour. This option may also require granulation, depending on the formulation and excipients used.
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From page 126... ...
The government could take the following specific actions to encourage ACTs production: • waive any existing duties on imported equipment, raw materials, solvents, and other materials involved in ACTs production • donate land for farming of A annua • enforce a ban on antimalarial monotherapies for uncomplicated malaria • provide an administrative infrastructure • assist in training and research • purchase media advertising to promote effective malaria therapy and completion of courses of treatment • pass legislation to require the distribution and use of ACTs in all government schools, hospitals, and agencies.
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From page 127... ...
Yves Champey Drugs for Neglected Diseases initiative Catherine Falade University of Ibadan Hellen Gelband Institute of Medicine, U.S. National Academies Michael Greene U.S.
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