Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cas­es of mon­key­pox now sit at well over 100 world­wide and have spread to mul­ti­ple con­ti­nents, the or­ders for any type of vac­cine against mon­key­pox are see­ing na­tions and med­ical bod­ies look­ing to get their hands on any­thing and every­thing. And now SIGA Tech­nolo­gies seems to be get­ting in on the ac­tion.

Ac­cord­ing to Eu­ronews, SIGA Tech­nolo­gies, a phar­ma­ceu­ti­cal com­pa­ny that is fo­cused on pro­vid­ing med­ical coun­ter­mea­sures to bi­o­log­i­cal and chem­i­cal at­tacks, is now in talks with sev­er­al Eu­ro­pean au­thor­i­ties look­ing to stock­pile its an­tivi­ral that can counter mon­key­pox. The drug known as tecovir­i­mat or Tpoxx was ap­proved by the FDA in 2018 as a vac­cine for small­pox but was ap­proved by the Eu­ro­pean Med­i­cines Agency to al­so act against mon­key­pox, cow­pox and com­pli­ca­tions from im­mu­niza­tion with vac­cinia.

Ac­cord­ing to SIGA CEO Philip Gomez,  the com­pa­ny will an­nounce or­ders as they con­firm quan­ti­ties, but the first step in con­ver­sa­tions with gov­ern­ment of­fi­cials has been fo­cused on Tpoxx us­age for cur­rent mon­key­pox cas­es.

Ac­cord­ing to SIGA, Tpoxx is an oral­ly ad­min­is­tered and IV for­mu­la­tion treat­ment, with the com­pa­ny and the US gov­ern­ment main­tain­ing a re­la­tion­ship since 2013 ac­cord­ing to Gomez. The US main­tains a stock­pile of 1.7 mil­lion cours­es in the Strate­gic Na­tion­al Stock­pile un­der Pro­ject BioShield. The IV ver­sion of the drug was re­cent­ly ap­proved by the FDA on Thurs­day and is in­tend­ed for pa­tients who are un­able to swal­low the oral ver­sions of the drug.

“The de­mand will be dri­ven by the facts around the out­break, but it is very im­por­tant to rec­og­nize that this an­tivi­ral was de­vel­oped as a treat­ment for small­pox, which spreads rapid­ly and his­tor­i­cal­ly had a mor­tal­i­ty rate of 30%,” Gomez said. “Tpoxx is cur­rent­ly on­ly stock­piled in the US and Cana­da, but we an­tic­i­pate this out­break will re­sult in more coun­tries stock­pil­ing the ther­a­py.”

No in­di­ca­tions have been giv­en that any of the peo­ple who have been di­ag­nosed with mon­key­pox have re­ceived Tpoxx as a treat­ment.

How­ev­er, be­fore the cur­rent sit­u­a­tion, sev­er­al North Amer­i­can na­tions had been look­ing to stock up on the drug. In Jan­u­ary of last year, SIGA and the Health Agency of Cana­da inked a deal for Cana­da to pur­chase $33 mil­lion worth of the oral ver­sion of the drug. Ear­li­er this month, the US De­part­ment of De­fense pro­cured $7.5 mil­lion worth of oral as well.

The news over their re­cent deals has caused their stock to soar, with their price $SIGA in­creas­ing 74% over the past five days, with their stock al­so up 64% since the be­gin­ning of the year.

How­ev­er, this trend is not unique to SIGA, as oth­er com­pa­nies in the small­pox vac­cine man­u­fac­tur­ing busi­ness are ex­pe­ri­enc­ing pos­i­tive stock bumps as na­tions look to place their or­der and stock­pile.

As re­port­ed by End­points News on Fri­day, Emer­gent BioSo­lu­tions’ stock jumped more than 10% on Fri­day, four days af­ter the com­pa­ny plumped down $225 mil­lion for the rights to Chimerix’s small­pox vac­cine. Chimerix’s stock $CM­RX was up more than 3.8% on Fri­day. And Bavar­i­an Nordic $BVN­RY — which closed a $119 mil­lion deal with BAR­DA to pro­vide the US gov­ern­ment with freeze-dried dos­es of the Jyn­neos small­pox vac­cine — was up near­ly 2.5%.

The sto­ry has been up­dat­ed to re­flect com­ment and analy­sis from Philip Gomez. 

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).