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.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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