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A conversation with the CEO making Tpoxx – Endpoints News & More News

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Phil Gomez, CEO of Siga Tech­nolo­gies, is hav­ing a busy sum­mer.

His com­pa­ny, which makes the on­ly avail­able mon­key­pox treat­ment, has been prepar­ing for this mo­ment for the last decade, work­ing with a team of sup­pli­ers and ramp­ing up just ahead of the out­break — hop­ing that it would nev­er have to de­ploy its treat­ment.

First ap­proved in 2018 for small­pox, and known as Tpoxx or tecovir­i­mat, the FDA didn’t ini­tial­ly ex­tend the ap­proval to mon­key­pox be­cause the com­pa­ny didn’t run a tri­al pri­or to the cur­rent out­break even though a tri­al could’ve the­o­ret­i­cal­ly been done.

Still, next week, the US plans to ramp up ship­ments of the drug and send out 55,000 dos­es to states and oth­er ju­ris­dic­tions, which is more than dou­ble the cur­rent sup­ply.

So what should peo­ple ex­pect in terms of ac­cess­ing this treat­ment? Is the clin­i­cal tri­al da­ta com­ing? And who’s mak­ing the de­ci­sions around the cur­rent dis­tri­b­u­tion? Read be­low a light­ly edit­ed phone in­ter­view with Gomez from Fri­day morn­ing.

End­points: Can you help me un­der­stand the math bet­ter — if there are about 13,000 con­firmed cas­es by the CDC, and the US says it’s ship­ping out 55,000 dos­es of Tpoxx be­gin­ning next week — shouldn’t every­one who wants the an­tivi­ral get ac­cess to it?

Gomez: I’ll have to de­fer to the CDC and FDA on how they’re do­ing it. It wasn’t clear to me that they’ve changed the cri­te­ria on who would re­ceive the dos­es, and it sound­ed like [they] said they will still fo­cus on pro­vid­ing Tpoxx to high-risk pa­tients. But by pre-po­si­tion­ing more cours­es, they will be able to more rapid­ly get cours­es to pa­tients.

End­points: Is the plan still to ramp up to about 600,000 cours­es of Tpoxx per year, and are you work­ing with con­tract man­u­fac­tur­ers to ramp up pro­duc­tion?

Gomez: There are 1.7 mil­lion dos­es of Tpoxx in the Strate­gic Na­tion­al Stock­pile, so we de­liv­ered those be­gin­ning in 2013, and start­ed de­liv­er­ing more in 2020 — so there is still a sub­stan­tial amount in the SNS. In terms of the CMOs, Siga works with WR Grace and Co. on the ac­tive in­gre­di­ent, Catal­ent for en­cap­su­la­tion, PCI for pack­ag­ing, and Pow­der­size [a Lon­za sub­sidiary] mi­cronizes and tests API for use.

End­points: The NIH next month is about to kick off a place­bo-con­trolled mon­key­pox tri­al in the US, fund­ed and spon­sored by the NIH. Can you talk about Siga’s in­volve­ment in the tri­al?

Gomez: We’re sup­port­ing 10 ran­dom­ized-con­trolled tri­als around the world via gov­ern­ment pub­lic health agen­cies, and we pro­vide drug, place­bo and ex­per­tise, and the good news is these pro­to­cols have been shared broad­ly across the US, Cana­da, UK and EU. So we’re hope­ful wher­ev­er the out­break goes, we’ll have an op­por­tu­ni­ty to rapid­ly col­lect da­ta and file that in the US and Cana­da.

We have ap­proval in the UK and Eu­rope for mon­key­pox, but the NI­AID tri­al would ul­ti­mate­ly al­low us to sup­port a US ap­proval for Tpoxx in mon­key­pox. From a high-lev­el per­spec­tive, these out­pa­tient tri­al pro­to­cols will look at the res­o­lu­tion of symp­toms, with a sec­ondary end­point of re­duc­ing vi­ral load. If any­one pro­gress­es to se­vere dis­ease, they would be un­blind­ed and switched to ac­tive drug.

End­points: How would you com­pare this tri­al to the Covid-19 vac­cine and drug tri­als from ear­li­er in the pan­dem­ic?

Gomez: It’s very dif­fer­ent than a Covid vac­cine tri­al be­cause it’s just look­ing at symp­toms re­solv­ing, which usu­al­ly on­ly last three to four weeks and Tpoxx will po­ten­tial­ly short­en that. With hope­ful­ly hun­dreds en­rolled, these tri­als should be much more rapid than the vac­cine tri­al, but it will de­pend on the out­break and where peo­ple are en­rolled.

End­points: US gov­ern­ment of­fi­cials have dis­trib­uted about 22,000 dos­es of Tpoxx so far. Any idea what the da­ta have shown in terms of the treat­ment work­ing?

Gomez: We haven’t got­ten back any re­al-world ev­i­dence from the CDC yet, so I de­fer to them. Broad­ly, we’ve been ac­tive­ly col­lect­ing da­ta on mon­key­pox, there were da­ta from the UK pub­lished last year, there’s been com­pas­sion­ate use treat­ment in the Cen­tral African Re­pub­lic, and there’s an­oth­er RCT that we’ve set up along­side NI­AID in the De­mo­c­ra­t­ic Re­pub­lic of Con­go be­fore the cur­rent out­break.

The FDA said in 2018 that when we won ap­proval for small­pox, that we couldn’t win one for mon­key­pox per the An­i­mal Rule be­cause we could’ve run a tri­al in the DRC. But the FDA has al­so said the DRC clade is dif­fer­ent from the cur­rent one, so now, with the broad out­break, un­for­tu­nate­ly, the op­por­tu­ni­ty is to col­lect the re­al world da­ta.

End­points: The de­ci­sion to use an ex­pand­ed ac­cess pro­gram to dis­trib­ute Tpoxx — was that a de­ci­sion Siga made? And any plans to move Tpoxx in­to the com­mer­cial mar­ket?

Gomez: The CDC made that de­ci­sion. The drug was de­vel­oped for small­pox and we’ve on­ly ever sold it to gov­ern­ments. So we have not looked at the com­mer­cial sales chan­nels, but we cer­tain­ly now are work­ing to eval­u­ate and plan to put it through the com­mer­cial mar­ket, but that will take time. We’re look­ing at the RCT da­ta as an in­flec­tion point for that.

End­points: Did you push back against the idea of us­ing an ex­pand­ed ac­cess pro­gram to dis­trib­ute Tpoxx?

Gomez: They [the CDC] have the prod­uct in the SNS so they con­trol it. We don’t have a lot of in­put on that.

End­points: And HHS yes­ter­day an­nounced the for­mu­la by which states and ju­ris­dic­tions would be al­lo­cat­ed Tpoxx — did you work with HHS on that for­mu­la?

Gomez: Yes­ter­day was the first time I saw it. The drug is in the SNS. I think we’re viewed more as a sup­pli­er.

End­points: What can you say about the sup­ply and de­mand of Tpoxx world­wide — giv­en that it’s so dif­fi­cult to find in the US, is there a short­age right now? And can you meet the grow­ing de­mand?

Gomez: This is a ques­tion we look at every day. I think most pub­lic health or­ga­ni­za­tions saw the ini­tial out­break and thought it wouldn’t be so dead­ly, so they took a let’s wait-and-see ap­proach. Then in the next phase, as cas­es start­ed to grow, coun­tries bought small sup­plies to treat the cur­rent out­break, and we’ve been work­ing pre­dom­i­nant­ly in that space, and have $60 mil­lion in in­ter­na­tion­al or­ders of prod­uct.

We’re now in the next phase which is where can see this out­break go, and what might we need over the next year or two, and that’s evolv­ing and we have prod­uct avail­able but we don’t know where it will go.

If mil­lions and mil­lions of cours­es are need­ed, we will need to rad­i­cal­ly re­think our sup­ply net­work and ex­pand it. But we just don’t know where it goes.

To pro­vide con­text: In 2020 and 2021, we de­liv­ered about 363,000 cours­es to the US gov­ern­ment, and we an­tic­i­pat­ed de­liv­er­ing that next year and the year af­ter, so we an­tic­i­pat­ed a lot of de­liv­er­ies over the next few years, and we ad­vanced pro­duc­tion of Tpoxx to make sure API was avail­able, so we, for­tu­nate­ly, were in a good place when the out­break hit.

In the fu­ture, there isn’t an ac­tive or­der for oral Tpoxx from BAR­DA but there are two re­main­ing or­ders from a 2018 con­tract and sev­er­al oth­ers for in­tra­venous ver­sions of the drug.

End­points: So if there isn’t a short­age of treat­ments right now, why is it still so dif­fi­cult to get? And why is the gov­ern­ment ret­i­cent to ship out more?

Gomez: That’s a ques­tion for CDC. Dis­tri­b­u­tion is their purview, and there are a lot of com­pli­cat­ed reg­u­la­tions be­cause of the SNS, and the fact that it’s ap­proved for small­pox and not mon­key­pox. We get a lot of ques­tions about use and dos­ing of the drug, and how to give it to chil­dren. For any­one un­der 13 kilo­grams [about 29 pounds], the tablet has to be frac­tion­at­ed, which has been done so far for some chil­dren, and we’re work­ing on a liq­uid re­sus­pen­sion dose that hasn’t been used yet.

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