Every time a scary virus captures global headlines, the FDA's first response is to vow to hurry along experimental therapies in what can appear like a miraculous intervention to a group of small biotech companies that suddenly finds itself in the global spotlight. Back in 2009 it was BioCryst and its controversial antiviral peramivir that benefited during a swine flu outbreak. Today, Tekmira ($TKMR) finds itself in a familiar situation, joined by a small biotech which reportedly provided an experimental intervention treatment credited with reversing one doctor's rapid decline.
A month ago, Tekmira shares took a deep dive after the FDA placed a clinical hold on its Ebola therapy, the RNAi therapy TKM-Ebola, citing concerns about cytokine release--a condition which can spur a fatal noninfectious fever in the worst cases. The Canadian biotech's shares shot up more than 12% on Monday morning on speculation that the FDA would put the treatment back on its fast track, with regulators from the FDA telling Reuters that they were ready to move ahead on speeding a therapy to approval rather than waiting on the time-consuming approach of multiple clinical trials. That followed a spike on Friday as investors who like to back small biotechs jumped into the game.
Tekmira's Monday morning spike, though, quickly faded as a new entry from Mapp Biopharmaceuticals suddenly figured into the newly conceived race to an accelerated approval. The small San Diego-based biotech has been developing a cocktail of antibodies dubbed MB-003 that triggers an immune response to Ebola--which rapidly overwhelms its victims with hemorrhagic fever.
A year ago, researchers for the U.S. Army Medical Research Institute of Infectious Diseases found that MB-003 was able to save 43% of infected nonhuman primates who were infected by Ebola and allowed to develop symptoms of the disease. The NIH rushed doses of the experimental therapy to Liberia and within an hour of being treated, physicians said they could see that Kent Brantly's symptoms were being reversed.
Normally, a drug like MB-003 would face a lengthy test before regulators would allow their use. But FDA officials told Reuters they were ready to work on accelerating the process under special emergency new drug applications.
That may be particularly important for a field like Ebola, where there's currently only a small market in developing countries. In this field, even small, largely unknown developers can suddenly find themselves with a hot prospect. Though once the prospect of an epidemic recedes, public attention can drop off as fast as it develops.
- here's the report from Reuters
- here's the story from CNN