Emer­gent inks $225M cash small­pox deal as Chimerix im­plodes on re­org, FDA trou­ble

Emer­gent BioSo­lu­tions has made a name for it­self ever since the late 1990s by mak­ing drugs that are need­ed by the US gov­ern­ment. Mon­day, it took that a step fur­ther, as it en­tered a deal with Chimerix to ac­quire the ex­clu­sive rights to Tem­bexa, a small­pox treat­ment for all ages that was ap­proved in 2021, with a $225 mil­lion cash pay­ment.

The pick­up comes just as Chimerix re­leased its Q1 earn­ings re­port, in which CEO Mike Sher­man said that the com­pa­ny is drop­ping in­vest­ment in an­oth­er pro­gram while cir­cling its wag­ons around the lead drug af­ter hopes for an ac­cel­er­at­ed ap­proval were dam­aged by reg­u­la­tors. And that will set up a piv­otal tri­al in ad­vance of any ex­pect­ed ap­proval — news that sent in­vestors run­ning for the hills as its stock $CM­RX plunged 60%.

Emer­gent’s SVP of gov­ern­ment busi­ness Paul Williams said that the deal for the small mol­e­cule drug ex­pands its work in the gov­ern­ment’s small­pox pre­pared­ness strat­e­gy. The deal will come to­geth­er with an an­tic­i­pat­ed BAR­DA con­tract in the next three to six months fol­low­ing the clos­ing of this deal. The clos­ing of the deal is con­tin­gent on se­cur­ing that con­tract. Emer­gent will pay Chimerix a $225 mil­lion one-time up­front pay­ment up­on clos­ing, and a to­tal of $100 mil­lion in mile­stone pay­ments. The terms al­so in­clude sales-based roy­al­ty pay­ments.

Tem­bexa, which is an oral an­tivi­ral for­mu­lat­ed as 100 mg tablets, is in­di­cat­ed to treat small­pox in adults, chil­dren and new­borns. When the FDA an­nounced the ap­proval, it not­ed that though the virus that caus­es small­pox was erad­i­cat­ed in 1980, it is be­lieved that it could be used as a bioweapon in the fu­ture.

“The ad­di­tion of Tem­bexa to Emer­gent’s port­fo­lio of med­ical coun­ter­mea­sures builds up­on our core ca­pa­bil­i­ties and lever­ages our long and suc­cess­ful his­to­ry part­ner­ing with the US gov­ern­ment to ad­dress dan­ger­ous pub­lic health threats,” CEO Bob Kramer said. “It ex­em­pli­fies our thought­ful M&A strat­e­gy as part of our 2024 growth plan and po­si­tions us bet­ter to de­liv­er val­ue for our share­hold­ers.”

The ef­fec­tive­ness of Tem­bexa had to be stud­ied in an­i­mals with virus­es that are close­ly re­lat­ed to the var­i­ous virus, be­cause the var­i­ous virus no longer ex­ists.

The pick­up is a win for Emer­gent, right when the com­pa­ny was in need of some­thing pos­i­tive. At the end of April, the long­time CEO and co-founder of the CD­MO died of can­cer, less than a month af­ter re­tir­ing from his role as chair­man of the board of di­rec­tors.

Then, a re­port from the US House se­lect sub­com­mit­tee on the coro­n­avirus cri­sis re­port­ed that the num­ber of Covid-19 vac­cine dos­es tossed due to cross con­t­a­m­i­na­tion prob­lems at its Bal­ti­more plant was more like 400 mil­lion, as op­posed to the much small­er amount orig­i­nal­ly re­port­ed. The re­port al­so al­leged that Emer­gent ex­ec­u­tives tried to sweep the prob­lems un­der the rug, and ig­nored re­ports from qual­i­ty con­trol di­rec­tors say­ing that the site wasn’t fit for the task it was about to take on. Emer­gent has adamant­ly de­nied the re­port’s find­ings.

“To equate these qual­i­ty con­trol ac­tions with a ‘dis­card­ed dose’ fig­ure dis­plays a lack of un­der­stand­ing re­gard­ing the bio­man­u­fac­tur­ing process,” a state­ment said.

Emer­gent has made gov­ern­ment con­tracts its bread and but­ter ever since it land­ed a deal with the US for its an­thrax vac­cine around the time of the Sept. 11, 2001 at­tacks. That was its on­ly drug then, and short­ly af­ter, it re­vamped its man­u­fac­tur­ing sites and ramped up its im­mu­niza­tion pro­gram. Emer­gent land­ed a big $400 mil­lion con­tract with BAR­DA for its an­thrax vac­cine again in Oc­to­ber 2021. It was award­ed a $628 mil­lion con­tract from Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion to man­u­fac­ture Covid-19 vac­cines with no com­pet­i­tive bid­ding back in 2020, which even­tu­al­ly led to the Bal­ti­more mishap.

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.

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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.