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. 

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.