EXCLUSIVE: SIGA Technologies CEO Says Company Is Prepared To Respond To Monkeypox Outbreak With TPOXX Stockpile Upon Approval

SIGA Technologies Inc SIGA shares have rallied about 50% since the World Health Organization declared monkeypox a public health emergency of global concern.

SIGA's lead product, TPOXX, is an orally administered antiviral drug for the treatment of smallpox. Monkeypox is in the same virus family as smallpox, but it causes milder symptoms.

"We're a treatment, we're a pill. You take it twice daily for 14 days and we have approval for monkeypox in Europe," SIGA CEO Philip Gomez said Wednesday on Benzinga's YouTube show "LIVE Trading."

What To Know: Although TPOXX was developed for the treatment of smallpox, the pivotal model which showed efficacy in animals was monkeypox in monkeys, Gomez said. TPOXX demonstrated a 95% ability to prevent death in monkeys with monkeypox, he added.

"It's a very effective drug in the monkeypox model and that's why we got approval in the U.S. [for smallpox]. In Europe, they looked at the same data and they gave us approval not only for smallpox, but for monkeypox," Gomez said.

The public health emergency of global concern designation is the highest alert level the WHO uses and shows that the organization believes a quick international response is necessary to stop the spread of the virus from escalating further. 

More than 18,000 monkeypox cases have been reported from 78 countries, according to an update from WHO on Twitter. WHO said in a statement over the weekend that it believes the outbreak can be stopped "with the right strategies in the right groups."

Why It Matters: SIGA could be involved in said strategies in order to help prevent an outbreak. Gomez commended the WHO's actions and called on governments to get ahead of the spread.

"I think it's important for WHO to elevate the level of awareness because what we need is governments to make sure they step up their preparedness [and make sure] that they have the vaccines and treatments available to deal with this outbreak, wherever it may go," Gomez said.

See Also: Monkeypox Emergency Could Last Months, According To Experts

If the outbreak were to worsen, SIGA is ready to respond. The company's drug was developed to be stockpiled, Gomez said.

"It's a lot easier to respond to a pandemic than prepare," the SIGA CEO said.

Gomez told Benzinga that there is enough TPOXX in the Strategic National Stockpile to treat 1.7 million people. The drug is available for distribution through the government, however, regulators are requiring all individuals who receive the drug to enroll in an expanded access investigational new drug protocol in order to collect more data.

"Unfortunately, that means they have to sit for three or four hours to enroll in that study," Gomez explained. 

The CDC and FDA updated their guidance earlier in the week and have talked about updating it again to make the drug more readily available, according to the SIGA CEO.

"The reality is there's plenty of drug in the U.S. The CDC and FDA are working to distribute it more rapidly to patients. We've seen, certainly, anecdotal evidence from people taking it. They're seeing symptoms resolve quickly. Obviously, we're not approved for it yet, but it's very encouraging," Gomez said.

See the full interview with the SIGA CEO here:

SIGA Price Action: SIGA shares are making new 52-week highs on Wednesday.

The stock ended the session 2.7% higher at $17.90. 

Photo: Jernej Furman from Flickr.