It’s beginning to sound like something from a Hollywood disaster movie.
The World Health Organization (WHO) says the Ebola virus has been spreading faster than health workers can control it. The potential for catastrophe includes the possibility that the fearsome disease will spread outside West Africa.
The WHO has launched an all-out $100 million spending campaign to get the outbreak under control, and the World Bank has followed up with an emergency $200 million pledge. It has been blamed for killing over 900 people in Guinea, Liberia and Sierra Leone in a short time, but it might not stop in Africa.
One thing that can help the usually fatal Ebola to cross borders and spread readily among populations is the fact it can take anywhere from two to 21 days before symptoms appear. Someone who contracts the virus in Lagos can board a plane and be in Tokyo or New York long before they know they are sick.
It was only last month that the Food and Drug Administration put a clinical hold on one Ebola drug treatment that was already in trials with human subjects. The treatment, TKM-Ebola, proved highly effective as a potential Ebola vaccine in treating primates.
The pressure has been mounting on the FDA to push ahead with immediate human testing of several potential drugs, including a candidate called TKM-Ebola.
There is ample precedent for an emergency health waiver on clinical testing. For instance, in 2009, BioCryst Pharmaceutical’s (Nasdaq: BCRX) experimental drug for treating H1N1 swine flu gained emergency approval as a pandemic took hold. BioCryst shares vaulted over 300% on the news.
The developer of TKM-Ebola is Tekmira Pharmaceuticals (Nasdaq: TKMR), a Canada-based biopharmaceutical firm that also has a bevy of other promising potential drugs in its pipeline.
For starters, the company has a $140 million contract from the U.S. Department of Defense to develop the drug, which shows the company will make money for bringing TKM-Ebola to fruition even if it doesn't prove to be a commercial success.
But there is more to the Tekmira story: The company specializes in the field of gene silencing — also known as RNA interference, or RNAi — that could well have blockbuster potential.
Tekmira also has a partnership with agricultural giant Monsanto (NYSE: MON) for use of Tekmira’s proprietary lipid nanoparticle delivery technology and intellectual property. The potential application for gene silencing in agriculture — especially where more disease- or drought-resistant crops might be the result — could be remarkable.
Tekmira is also teaming up with a variety of pharmaceutical firms. In May, Tekmira began a Phase I/II clinical trial of TKM-PLKI, its RNAi candidate for treatment of liver cancer. It also began a separate Phase I/II trial of the same drug candidate for gastrointestinal tumors.
In what could be its most promising research, Tekmira is making progress toward a drug to treat the hepatitis B virus, which affects more than 350 million people worldwide. Its TKM-HBV treatment candidate is designed to block the viral protein emitted by hepatitis B, which could allow patients to generate their own antibodies to fight the disease.
Tekmira is a development-stage biopharmaceutical firm, industry-speak for a company with drugs in the pipeline that is still losing money. In its most recent quarterly filing, the company said it lost $20 million — but it had $134 million in cash on its books and zero debt. Analysts at Zacks estimate that supply of cash alone could sustain the company into 2016.
Risks to Consider: Tekmira is focused only on revolutionary RNA interference drugs, which work by “silencing” disease-causing genes. The high-stakes gamble of going where other drug companies have not yet might not be entirely successful. Tekmira depends on the Department of Defense and larger pharmaceutical partners for most of its revenue, and expects to rely on third parties to handle the sales, marketing and distribution of its landmark drug candidates.
Action to Take –> Tekmira is a speculative buy with a potentially remarkable return based on its novel RNAi approach. The drugs in its pipeline indicate that holding TKMR for the medium term could yield solid profits. Zacks has a $25 price target on the stock, which would give it a $475 million market cap — in line with similar biopharmaceutical companies with pipeline drug candidates that are hoping for big payoffs. That price target represents upside north of 80% from current levels.
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