As mon­key­pox quick­ly spreads, a hand­ful of biotechs spring to ac­tion

At the be­gin­ning of the week, many peo­ple hadn’t ever heard of mon­key­pox. By Fri­day, that all changed — and now a hand­ful of biotech com­pa­nies are reap­ing the ben­e­fits.

Emer­gent Bioso­lu­tions’ $EBS 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 vac­cine — was up near­ly 2.5%.

The news comes just a cou­ple days af­ter the first mon­key­pox case was de­tect­ed in the US, and on Fri­day the CDC re­vealed it’s mon­i­tor­ing at least six oth­er Amer­i­cans af­ter they came in close con­tact with an in­fect­ed trav­el­er ear­li­er this month. Cas­es are surg­ing in Eu­rope, where Spain has now iden­ti­fied 30 cas­es, and neigh­bor­ing Por­tu­gal has re­port­ed 23.

Make no mis­take, though: The cur­rent sit­u­a­tion is noth­ing like Covid, ac­cord­ing to Nor­man Bay­lor, who once di­rect­ed the FDA’s Of­fice of Vac­cines Re­search and Re­view and now serves as a con­sul­tant.

“The good news is we have a vac­cine. Re­mem­ber with Covid, we had noth­ing. We were start­ing from scratch,” he said.

Mon­key­pox has been around since 1958, when two out­breaks oc­curred in colonies of re­search mon­keys (hence the name). How­ev­er, the first hu­man case wasn’t re­port­ed un­til over a decade lat­er in the De­mo­c­ra­t­ic Re­pub­lic of Con­go. The US saw an out­break back in 2003, af­ter re­ceiv­ing a ship­ment of an­i­mals from Ghana, which was con­tained with test­ing and vac­ci­na­tion, ac­cord­ing to the CDC.

Be­cause mon­key­pox is sim­i­lar to (but milder than) small­pox, cur­rent­ly ap­proved small­pox vac­cines like Chimerix’s Tem­blex should of­fer some pro­tec­tion against mon­key­pox, ac­cord­ing to Daniel Ku­ritzkes, chief of in­fec­tious dis­eases at Brigham and Women’s Hos­pi­tal in Boston. In fact, most old­er adults are al­ready vac­ci­nat­ed (rou­tine vac­ci­na­tion end­ed in 1972 af­ter the dis­ease was erad­i­cat­ed in the US).

Even though a large pop­u­la­tion re­mains un­vac­ci­nat­ed, both Bay­lor and Ku­ritzkes doubt that the US will need to roll out a wide­spread vac­cine cam­paign to con­tain the cur­rent out­break.

Nev­er­the­less, BAR­DA is pay­ing Bavar­i­an Nordic $119 mil­lion to ex­er­cise op­tions for a freeze-dried stock­pile of Jyn­neos, which cov­ers both mon­key­pox and small­pox. Ad­di­tion­al op­tions for an­oth­er 13 mil­lion dos­es through 2024 and 2025 would add up to $180 mil­lion.

Paul Chap­lin, CEO of Bavar­i­an Nordic, said in an in­ter­view with End­points News that the com­pa­ny has had a long-stand­ing re­la­tion­ship with BAR­DA and is ready for what­ev­er comes next.

BAR­DA’s new op­tion for the Jyn­neos vac­cine is part of a years-old col­lab­o­ra­tion with Bavar­i­an Nordic to cre­ate a vac­cine with a longer shelf-life. So the new deal is quite co­in­ci­den­tal con­sid­er­ing what’s hap­pen­ing in the world, Chap­lin said.

How­ev­er, he was quick to em­pha­size that Bavar­i­an Nordic has an im­me­di­ate stock­pile and the ca­pa­bil­i­ty to pro­duce more. It has over a mil­lion dos­es in stock cur­rent­ly for BAR­DA, most of which is stored at their fa­cil­i­ty in Den­mark.

The com­pa­ny usu­al­ly sells Jyn­neos on an on­go­ing ba­sis, typ­i­cal­ly man­u­fac­tur­ing for or­der as there hasn’t been much in­ter­est in stock­pil­ing for small­pox. How­ev­er, Chap­lin said he ex­pects to be­gin sup­ply­ing EU coun­tries in the com­ing days and is man­u­fac­tur­ing more dos­es as we speak, though he didn’t dis­close any of the de­tails.

“I think gov­ern­ments are tak­ing the emer­gence of new in­fec­tious dis­eases ex­treme­ly se­ri­ous­ly. So I think that’s one thing, which is a pos­i­tive sign,” he said. “There are a num­ber of gov­ern­ments, Cana­da, the Unit­ed States, and ac­tu­al­ly a few coun­tries in Eu­rope [that] have ac­tu­al­ly pre­vi­ous­ly pur­chased Jyn­neos to stock­pile.”

Mean­while, Emer­gent snagged the rights to Tem­bexa, a small­pox treat­ment for all ages that was ap­proved in 2021, with an an­tic­i­pat­ed BAR­DA con­tract in the wings. The com­pa­ny is ea­ger for a come­back af­ter a re­port from the US House se­lect sub­com­mit­tee re­vealed that around 400 mil­lion Covid-19 vac­cine dos­es were like­ly tossed due to cross con­t­a­m­i­na­tion prob­lems at its Bal­ti­more plant.

Should the US need to roll out vac­cines, the re­al ques­tion will be who gets them first, Bay­lor said. British au­thor­i­ties re­cent­ly prompt­ed health­care work­ers and oth­ers who were ex­posed to get vac­ci­nat­ed, ac­cord­ing to a Reuters re­port.

“The sup­ply is not enough to roll out to every­body,” he said. “That would re­al­ly need some dis­cus­sion, and we’re not at that point yet.”

Aa­dia Rana, an as­so­ciate pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Al­aba­ma-Birm­ing­ham, told End­points that it’s un­clear whether those who have been vac­ci­nat­ed against small­pox in the past will need to be re­vac­ci­nat­ed. How­ev­er, William Schaffn­er, an in­fec­tious dis­ease ex­pert from Van­der­bilt Uni­ver­si­ty, point­ed out that small­pox vac­cines can pro­vide long-term pro­tec­tion. Like any vac­cine, though, pro­tec­tion di­min­ish­es over time.

“I am re­al­ly quite con­fi­dent that the pub­lic health au­thor­i­ties in the US and Cana­da and in Eu­rope will rather quick­ly bring these var­i­ous chains of trans­mis­sion to a close and it’s an ex­ot­ic event,” Schaffn­er said. “It’s an­oth­er in­di­ca­tion that we live to­geth­er on a very small globe, and that strange in­fec­tions can ap­pear very dis­tant­ly, and all of a sud­den show up in your neigh­bor­hood.”

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”