IHS Chemical Week


Manufacturing Opportunity in Drugs for Infectious Diseases

2:21 AM MST | December 14, 2011 | By GIRISH MALHOTRA

The spread of infectious diseases such as HIV/AIDS, malaria, schistosomiasis, and tuberculosis are a cause for global concern. Pharmaceutical companies have developed - and continue to develop - and market drugs that are effective for their cure. Patients in industrialized countries have been able to use their respective healthcare systems for their needs. However, similar healthcare systems are not available in the developing and underdeveloped countries. The number of patients in these countries is very large. Patients are unable to afford these drugs1. Governments in these countries do not have the funding to educate and distribute the necessary medicines to cure and control the spread of the diseases listed above.
Many governments, including that of the U.S., non-government organizations, and foundations such as the Clinton Foundation, and the Bill and Malinda Gates Foundation, through financial contributions are making a significant progress toward the cure and control of these diseases. This is being done through education and the distribution of drugs.
Prices of new medicines are set at a level and specifically designed for patients in the industrialized countries that have healthcare programs. Many patients in the developing and economically stressed countries cannot afford these drugs. Governments and companies in India, China and other countries are using compulsory/voluntary licensing along with emergency declaration to manufacture some of these drugs to fulfill their needs. The prices of the drugs in these countries are significantly lower compared to the prices in industrialized countries but still can be high for poor economies.
Every effort is being made to make a dent in the spread of these diseases. President Clinton2 recently suggested the use of emergency criterion even to distribute these drugs in industrialized countries. With the current global financial crunch, funding is strained but the need persists. There could be a financial shortfall also.
Mileage of the existing funds can be extended by improving process yields and manufacturing technologies of the active pharmaceutical ingredients (API) and their formulations. Yields of the existing chemistries can be improved through their review, and the review of their manufacturing practices. The chemical process yield of many APIs are less than 66%. There are many products in this category. Low yields are cost improvement opportunities.
Efforts to improve the conversion yield3 for Tenofovir, part of the AIDS drug cocktail, have had good results. Its yield was improved from 13% to 24%. This has resulted in lowering the yearly cost to the patient of less than $90.00/year. There are significant opportunities, however, if the yield can be doubled to 48% or higher. Better execution of the process chemistries can also reduce the costs. Savings will improve the mileage of the contributed monies.
Based on published information, the yearly need for Praziquantel4, a drug for schistosomiasis,  is around 500,000 pounds/year and about one million pounds for Tenofovir5, an AIDS drug. Multiple plants are used to produce these products. Since the cumulative quantities are being produced at many sites, the value of economies of scale and better technology are diluted. A consolidation opportunity exists.
Consolidation will force the best chemistries to be used at fewer plants featuring the best manufacturing technologies. Production costs will come down. Profits for the companies that will be producing them can be better than they are today.
Improved manufacturing methods can enhance productivity and reduce process cycle time and so improve asset utilization. This can be achieved at zero - or minimal - cost. Improved productivity can result in better manufacturing technologies through economies of scale. Process sustainability can also be improved. All or part of the cost reductions can be passed on and funding monies will extend their mileage. Philanthropic dollars could be left over that could be used for other worthy causes.
The mindset to undertake external process and technology reviews and continuous process improvements does not prevail in pharmaceuticals manufacturing. Every inefficiency cost is passed on. If one or two companies break out of the pack they will change the landscape for the whole pharmaceutical industry. Supply chain issues could be addressed and resolved. That would be a win-win for all.
Girish Malhotra, PE
EPCOT International
1. Drug Prices: Food vs. Medicine - A Difficult Choice for Some http://pharmachemicalscoatings.blogspot.com/2011/06/drug-prices-food-vs-medicine-difficult.html
2. http://www.washingtonpost.com/national/health-science/obama-proposes-helping-more-people-get-access-to-aids-drugs/2011/12/01/gIQAxa5qHO_story.html
3. Ripin etal, Process Improvements for the Manufacture of Tenofovir Disoproxil Fumarate at Commercial Scale, Organic Process Research & Development, 2010, 1194-1201
4. WHO publication WHO/SCHIST0/89.102 Rev. l
5. Francoise Renaud-Théry and others, Utilization Patterns and Projected Demand of Antiretroviral Drugs in Low- and Middle-Income Countries AIDS Research and Treatment, Volume 2011, Article ID 749041, 8 pages doi:10.1155/2011/749041

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