The monkeypox outbreak has sent shares of the drugmaker SIGA Technologies up more than 200% this year, though the company's monkeypox antiviral remains hard to access in the U.S.
In an interview on Friday, SIGA (ticker: SIGA) executives told Barron's they planned to ask the Food and Drug Administration for approval or authorization for their drug TPOXX as a monkeypox treatment as soon as new efficacy data is available.
It's not clear how long that could take. On Thursday, the U.S. declared the monkeypox outbreak a public-health emergency, which would allow the FDA to issue emergency use authorizations for monkeypox therapeutics. On a media call, however, FDA Commissioner Dr. Robert Califf said that TPOXX still needed to be studied closely.
"We think it's going to be effective in monkeypox, but we have no proof of that yet," Califf said.
On Friday, SIGA's chief scientific officer, Dennis Hruby, said he was confident that the drug is effective as a monkeypox treatment. "I have no doubt it will work," Hruby said.
SIGA reported second-quarter revenue of $16.7 million late Thursday, and diluted earnings of three cents per share. SIGA shares jumped about 20% on Friday to $23.30.
There are just over 7,000 confirmed monkeypox cases in the U.S., and nearly 27,000 worldwide. The explosion of cases of a virus that had previously been endemic only in parts of Africa could vastly expand demand for SIGA's drug.
SIGA's business, until this spring, had been focused wholly on selling TPOXX into government stockpiles, largely for use in the case of an outbreak of smallpox. The FDA approved TPOXX as a smallpox treatment in 2018 under a rule that allows for the approval of drugs based on animal data, when human trials aren't ethical or feasible.
While SIGA did run safety and pharmacokinetic studies of TPOXX in humans, it tested the drug's efficacy only in monkeys, who were infected with monkeypox and then treated with TPOXX. SIGA had initially sought FDA approval for TPOXX both as a smallpox and a monkeypox treatment, but only received the agency's nod on the smallpox indication. European Union and U.K. regulators have both approved the drug to treat monkeypox based on the same monkey data.
Now, a number of randomized, controlled trials of TPOXX in monkeypox patients are set to start soon, including in the U.K. and the U.S. SIGA isn't running the trials, but is providing them with drugs and placebos.
"It'll depend on the number of monkeypox patients, but as soon as we have any data from those trials, whether interim analysis, final data, certainly we will submit that to FDA and make sure we try and expedite the approval, either through an EUA or formal approval," the company's CEO, Phil Gomez, told Barron's.
Still, Gomez said that access to the drug could be expanded ahead of trial data. "We're very supportive of the randomized control trials, and we should separate that from when does either an approval process or a change in policy allow greater access to the drug," he said.
Patients in the U.S. currently access TPOXX through what's known as an expanded access trial. The FDA and Centers for Disease Control and Prevention have eased the regulations in recent weeks, though enrollment still takes time.
SIGA executives say they could ramp up to manufacturing half a million doses of TPOXX a year. The company doesn't have its own manufacturing facilities, but rather relies on a number of contract manufacturing facilities.
"We don't have a factory that's going full-time on TPOXX," Gomez said. "The theoretical highest production is a function not only of how much capacity they have, but whether we get access to it and when we get access."
Gomez would not disclose the exact price the U.S. pays per treatment course, but says that it's around $300 to $400.
SIGA began delivering doses of TPOXX to the U.S. stockpile in 2013, and had delivered 1.7 million courses of the treatment to the U.S. by 2017. Doses in the stockpile began to expire in 2020, and SIGA delivered 363,000 courses to the U.S. to replenish stockpile that year, and 363,000 more in 2021.
Gomez said that SIGA had been planning to ramp up production this year even before the monkeypox outbreak. In addition to the 363,000 expired doses in the U.S. stockpile the company had planned to replace, the company also received European approval for the drug shortly before the outbreak began.
While only the U.S. and Canada stockpiled TPOXX in advance of the outbreak, more countries have sought in recent months to acquire doses. SIGA says that it has received approximately $60 million worth of orders this year from outside of the U.S., from 10 separate jurisdictions.
Gomez says the outbreak could change the long-term market for his company's medicine.
"Prior to the monkeypox outbreak, only the US and Canada really had a stockpile," he said. "This reminds us that it's important for governments to think about these outbreaks, because after an outbreak happens, it's very hard to get access to these products, given the lead times and the capacity."
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