Market News

 August 14, 2014
As Ebola's Toll Rises, Drug Makers Race to Test Medicines

 Because outbreaks are sporadic and mainly confined to Africa, the Ebola virus has not been a priority for profit-seeking pharmaceutical companies.

But with the largest ever Ebola outbreak now having killed more than 1,000 people in West Africa, drug companies and doctors are scrambling to see whether any existing medicines or drugs under development can help stem the epidemic.

Options include experimental treatments that have never before been tested on people and some of the world's most widely used drugs --- statins like Lipitor, which are approved to lower cholesterol but might, some advocates say, also help with Ebola.

The search is especially intense among smaller companies whose research has been funded by the government.

The search is especially intense among smaller companies whose research has been funded by the government.

At Heart of Ebola Outbreak, a Village Frozen by Fear and DeathAUG. 11, 2014

Investors, too, are watching the drug makers. Stock in one of the hopefuls, Tekmira, which is based in Canada, has nearly doubled in the last month. Shares of BioCryst Pharmaceuticals, which announced on Wednesday that it was receiving more federal money to test its Ebola drug candidate in monkeys and people, have also been rising.

Experts caution that most of these drugs are so early in development and in such limited quantities that they may not make a difference.

"I wish I had a better story for you, but that's it," one official at the Health and Human Services Department said after discussing the relative handful of drugs and vaccines in the pipeline, most of which have yet to be tested even in small clinical trials.

Despite the long odds, two Ebola vaccines could begin initial safety testing in people as early as next month, according to the official, who spoke on the condition of anonymity because his agency did not have formal contracts with some of the companies involved.

While testing will be in healthy volunteers, some of those volunteers might be health care workers who intend to go to Africa.

One of the vaccines was developed by a government laboratory in Canada. The Canadian government on Tuesday said it would donate 800 to 1,000 doses to the World Health Organization, presumably for use in Africa.

That vaccine is licensed to NewLink Genetics, a company in Ames, Iowa. Charles Link, the chief executive, said NewLink could manufacture tens of thousands of doses over the next couple of months.

The other vaccine is being developed by the National Institutes of Health and GlaxoSmithKline. There are 400 doses available now, enough for a clinical trial in healthy adults, the federal official said.

As far as treatments for people already stricken with Ebola, most attention has focused on ZMapp, developed by Mapp Biopharmaceutical of San Diego. The drug, which consists of antibodies that bind to and neutralize the virus, appears to have helped two American aid workers stricken in Liberia. Although the company says it has exhausted its supply --- apparently enough to treat only six people --- the federal official said he hoped 10 to 50 more treatment courses could be made by the end of the year, enough to begin a small safety study.

Tekmira's drug uses a technique called RNA interference to silence genes in the Ebola virus. Its early-stage clinical trial in healthy volunteers was halted by the Food and Drug Administration last month because of side effects. But the F.D.A. last week said that the drug was safe enough to test in people actually infected with Ebola.

Mark J. Murray, Tekmira's chief executive, told analysts Wednesday that the company was exploring possible use of the drug in Africa

Sarepta Therapeutics has said it has enough experimental drug left over to treat about two dozen people. The company stopped developing the drug, which also uses RNA interference, after the Defense Department halted its funding.

A flu drug being developed by Fujifilm Holdings of Japan has shown some effectiveness against Ebola in mice, and BioCryst also has an antiviral drug that has been tested in mice. The next step is for those drugs to work in monkeys.

"I have shelves full of things that protect rodents that don't work in monkeys," said Dr. Thomas W. Geisbert, a professor and Ebola expert at the University of Texas Medical Branch at Galveston. "If it doesn't protect a monkey, it's hard to imagine how you would push it forward for use in humans."

The World Health Organization said on Tuesday that it would be permissible to try to treat Ebola patients with untested medicines, providing certain ethical standards were observed.

Even so, Dr. Marie-Paule Kieny, the organization's assistant director general, was cautious. "It is very important to not give false hope to anybody that Ebola can be treated now," she said at a news conference in Geneva.

Since drugs directed specifically at Ebola are still in early development, some doctors are suggesting trying drugs already approved for other uses that are readily available and proved to be relatively safe --- like statins.

The champion of this idea is Dr. David Fedson, a retired professor and vaccine company executive living in France. He said that although statins did not attack the virus, they might help calm the runaway immune system reaction that could follow infection, which is what inflicts much of the damage on the body.

"The concept of treating the host response is sitting there in front of our noses," said Dr. Fedson, who has been trying to rally support for his proposal.

So far, however, the W.H.O. had turned up its nose at the idea, he said. Some Ebola experts are also skeptical.

"When you start talking about modulating the immune response, you can have unintended consequences," said Dr. Geisbert of the University of Texas.