A Canadian company investigating an experimental treatment for Ebola may be months away from making new drug supplies, offering no guarantee on Wednesday evening that its unapproved treatment would reach patients.
“The regulatory framework to support its use in Africa has not yet been established,” Tekmira Chief Executive Officer Mark Murray told analysts on an earnings call. “There can be no assurance that an appropriate framework” will be developed.
Vancouver-based Tekmira is one of several companies trying to develop treatments for the deadly virus that has killed more than 1,000 people in West Africa this year, mostly in Guinea, Liberia, and Sierra Leone. A World Health Organization panel this week concluded that in some Ebola cases, “it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”
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But using experimental drugs to treat sick patients is a thorny issue for pharmaceutical companies. Every treatment carries risks. New therapies go through years of testing to establish that they are safe and effective, and most would-be medicines never make it through that process. Taking a drug that hasn’t been through rigorous evaluation increases risks to patients. It can also complicate drug companies’ efforts to establish the scientific evidence for making a drug more widely available.
Early human trials to test Tekmira’s unproven Ebola therapy in healthy volunteers were put on hold on July 3 by the U.S. Food and Drug Administration over safety concerns. But last week regulators loosened some restrictions, sparking a surge in the company’s share price, as Bloomberg News reported. “The FDA reevaluated the risk-reward for use of the drug in infected patients as opposed to healthy volunteer subjects,” Murray told analysts.
Another experimental therapy, ZMapp, was given to two American aid workers. The company developing it, Mapp Pharmaceuticals, said this week that its supplies had been exhausted after providing doses to a West African nation, according to the Wall Street Journal.
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Murray wouldn’t answer analysts’ questions about the barriers to making Tekmira’s experimental Ebola drug available in countries affected by the outbreak. “These are early discussions. I have no answers to your questions,” he said. “We will update you as we learn and are able to confirm that there are pathways going forward.”
Supply of the drug may be an issue if Tekmira does move to get it to West African countries. Early-stage therapies don’t have manufacturing lines set up and may be created through labor-intensive lab work. Murray declined to specify how much was on hand, although he said Tekmira has some inventory for its clinical study under way. At the company’s current stage of research, those doses would likely cover less than 100 people—perhaps as many as a few hundred if Tekmira is preparing for mid-stage trials. Creating more doses, Murray said, would take months.
Revenue was $1.8 million for Q2 2014 as compared to $2.8 million for Q2 2013. Under the DoD contract to develop TKM-Ebola, Tekmira is being reimbursed for costs incurred, including an allocation of overheads, and is being paid an incentive fee. For this contract, Tekmira recorded $0.9 million in revenue in Q2 2014 as compared to $2.5 million in Q2 2013.
If they do develop a cure/vaccine, who owns it?
this is good!
IN talks with who? Not TKMR??? So their own government doesn't even want it eh?