Shares of this "Ebola stock" have soared in the past 24 hours - but just how close is Tekmira to getting approval for an Ebola treatment?
Tekmira Pharmaceuticals Corp. (Nasdaq: TKMR) stock surged more than 25% to $26.50 Wednesday after the Centers for Disease Control and Prevention (CDC) confirmed Tuesday the first Ebola diagnosis in the United States - and the first outside of Africa.
The CDC is confident it can control this case, but said it's possible that someone who has had contact with the man may have been affected.
As for how long the outbreak will last in ravaged Africa, Jason McDonald of the CDC responded in an email to Money Morning:
"It is impossible to predict how long an outbreak will continue. For now, we are taking concrete actions to stamp out the outbreak in West Africa. These include contact tracing, airport screening, and health education. CDC is prepared to be in this for the long haul and until the outbreak is over in order to protect the health of Americans."
Tekmira is also in it for the long haul. Here's a closer look at whether this company can be the first to deliver an Ebola treatment.
The Canadian drugmaker is developing an Ebola vaccine in collaboration with the U.S. Department of Defense's Medical Countermeasure Systems BioDefense Office.
In March 2014, Tekmira was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of TKM-Ebola, its anti-Ebola viral RNAi therapeutic. The FDA's Fast Track is a process designed to facilitate the development and expedite the review of drugs in order to get important new therapies to patients earlier.
In August, the FDA modified its clinical hold status on Tekmira's experimental Ebola treatment to partial hold, enabling it for potential use in humans infected with the virus.
TKM-Ebola is currently in phase 1 testing. But the company has already treated a few Ebola patients in the United States (aid workers transported here), as well as patients outside of the United States, with some success.
However, even if the CDC uses Tekmira's Ebola treatment for current or future patients, it will be on a limited basis.
Here's why...
Tekmira only has a limited supply of its Ebola treatment on hand. It would need several months or a year to make enough in order to supply a U.S. defense stockpile, according to RBC Capital Market's Robert Yee.
In addition to working with the U.S. government, Tekmira announced on Sept. 23 it has joined an international consortium to conduct clinical trials of Ebola virus therapeutics in West Africa.
The genetic sequence of the Ebola virus variant responsible for the ongoing outbreak in West Africa is now available. Under the program, Tekmira will produce an RNAi-based product specifically targeting the viral variant responsible for the current outbreak. The ability to rapidly and accurately match the evolving genetic sequences of emerging infectious agents is one of the powerful features of RNAi therapeutics.
Yet, there is no assurance Tekmira's therapy will be used in African countries.
"We are an active collaborator in this consortium and through our ongoing dialogue with the WHO [World Health Organization], NGOs [non-government organizations] and governments in various countries," Dr. Mark Murray, Tekmira's president and CEO, said in a statement. "We have been discussing the creation of appropriate clinical and regulatory frameworks for the potential use of investigational therapeutics in Africa. This initiative goes a long way towards achieving this aim. Many complex decisions remain to fully implement this unique clinical trial platform. At this time, there can be no assurances that our product will be selected by the consortium for clinical trials in Africa."
Still, RBC deems Tekmira the most advanced of the companies working on Ebola treatments, of which there are several.
The WHO says 3,091 people have died of confirmed Ebola cases so far this year. And the CDC estimates that by Jan. 20, 2015, the number of people infected with Ebola - just in Liberia and Sierra Leone - could rise to 1.4 million, with nearly half of those succumbing to the disease.
Also rising is the number of drug companies racing to develop an Ebola vaccine.
Sarepta Therapeutics Inc. (Nasdaq: SRPT) in August said it has a "drug that could be deployed and shipped." The Cambridge, Mass.-based company added that any use of the drug would require waivers and approval from the Department of Defense, which paid for the development of the drug, as well as the FDA. Sarepta's Ebola treatment is promising. The drug showed survival rates of 60% to 80% in primates, versus a 0% survival rate among untreated animals. SRPT shares rose 2.32% to $22.26 Tuesday.
BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) is another biotech with a pipeline drug that has shown promise fighting Ebola. In March, the Durham, N.C.-based small cap reported that its under-development drug, BCX4430, protected rodents against Ebola infections. BRCX shares rose 1.5% Tuesday to $10.35.
Others working on vaccines are pharma giant Glaxo SmithKline Plc. (NYSE ADR: GSK), unchanged at $45.98; small-cap NewLink Genetics Corp. (Nasdaq: NLNK), up 8% at $24; and microcap Hemispherx BioPharma (NYSEMKT: HEB), up 11% at $0.354.
Now: "Ebola stocks" are getting a lot of press right now, but no matter who is the first to develop an approved Ebola treatment, there's a much better investment to make today - a medical tech leader is already set up to treat the next major outbreak (and deliver huge gains to investors...)
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