Tekmira's Ebola Drug Faces Regulatory Barriers in Africa

Aug 14, 2014

Business Week

In addition to the ethical and supply concerns surrounding experimental Ebola drugs, companies developing treatments may also face regulatory issues when attempting to bring new drugs to Africa.

Tekmira Pharmaceuticals Corp., a Canada-based biopharmaceutical firm investigating an experimental treatment for Ebola, said that the "regulatory framework" to support dispensing its drug to patients in Africa "has not yet been established," given that the drug's safety and effectiveness has not been proven. Furthermore, Tekmira Chief Executive Officer Mark Murray told analysts that there is no assurance that the framework to support the new treatment -- TKM-Ebola -- in Africa will be developed.

Early stage human trials to test Tekmira’s Ebola therapy in healthy volunteers were put on clinical hold by the FDA in early July due to safety concerns. Last week, the FDA modified its stance to enable testing of Tekmira's drug in infected patients, although the hold on healthy volunteers is still in place, the company said.

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