All opinions are my own.

Sunday, December 11, 2011

Drugs for Infectious Diseases, Funding and Opportunity

Spread of infectious diseases such as HIV/AIDS, malaria, schistosomiasis, and tuberculosis are cause of a global concern. Pharmaceutical companies have and continue to develop and market drugs that are effective for their cure. Patients in the developed 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 not able to afford these drugs (1). Governments in these countries do not have the funding to educate and distribute the necessary medicines to cure and control their spread.

Many governments [notably US], NGOs, organizations and foundations [prominent among them are Clinton Foundation and Bill and Malinda Gates Foundation] through financial contributions are making significant effort for the cure and control of these diseases. This is being done through education and distribution of drugs.

Prices of the new medicines are set at a level and specifically designed for patients in the developed 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 the needs. The prices of the drugs in these countries are significantly lower compared to the prices in the developed countries but still can be high for these economies.

Every effort is being made to make a dent in the spread of these diseases. President Clinton (2) recently suggested use of emergency criterion even to distribute these drugs in the developed countries. With the current global financial crunch, funding is strained but the needs persist. There could be a financial shortfall also.

Mileage of the existing funds can be extended is by improving the process yields and manufacturing technologies of the active pharmaceutical ingredients and their formulations. Yields of the existing chemistries can be improved through their review and review of their manufacturing practices. Chemical process yield of many active pharmaceutical ingredients is less than 66%. There are many products in this category. Low yields are cost improvement opportunities.

Efforts to improve Tenofovir (part of the AIDS drug cocktail) conversion yield (3) have had good results. Its yield was improved from 13% to 24%. This has resulted in lowering the yearly cost to less than $90.00 per year. However, there are significant opportunities 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 yearly need for Praziquantel (4) (for schistosomiasis) is around 500,000 pounds per year and about one million pounds for Tenofovir (5) (for AIDS). Multiple plants are producing these products. Since the cumulative quantities are being produced at many sites, value of economies of scale and better technology are diluted. A consolidation opportunity exists.

Consolidation will force best of the chemistries to be used at few plants that will have best of the 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 i.e. improve asset utilization. This can be achieved at no 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. There could be left over philanthropic dollars that could be used for other worthy causes.

Thought of external process and technology review 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 and 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
2)Ripin etal, Process Improvements for the Manufacture of Tenofovir Disoproxil Fumarate at Commercial Scale, Organic Process Research & Development, 2010, 1194-1201
3)WHO publication WHO/SCHIST0/89.102 Rev. l
4)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