HHS Secretary Xavier Becerra (AP Photo/Patrick Semansky)

HHS lines up near­ly $700M in sup­ply deals to com­bat mon­key­pox and stock up on a small­pox treat­ment

The De­part­ment of Health and Hu­man Ser­vices is dou­bling down on ef­forts to se­cure more dos­es of Bavar­i­an Nordic’s mon­key­pox vac­cine and Chimerix’s small­pox treat­ment as the CDC re­veals that few peo­ple have com­plet­ed their full vac­cine se­ries.

BAR­DA an­nounced on Mon­day that it’s shelling out $11 mil­lion to Michi­gan-based Grand Riv­er Asep­tic Man­u­fac­tur­ing, which agreed ear­li­er this month to per­form fill and fin­ish ser­vices for Bavar­i­an Nordic’s mon­key­pox vac­cine Jyn­neos.

Rochelle Walen­sky

Jyn­neos re­mains the on­ly vac­cine that’s specif­i­cal­ly ap­proved by the FDA to pre­vent mon­key­pox — and though it’s a two-dose vac­cine, CDC di­rec­tor Rochelle Walen­sky said in a White House brief­ing on Fri­day that 97% of shots that have been de­liv­ered so far have been first dos­es.

“While we are en­cour­aged by the scale-up, there are many peo­ple el­i­gi­ble for sec­ond dos­es, and very few of the dos­es ad­min­is­tered so far are record­ed [as] sec­ond dos­es,” she said dur­ing the brief­ing. “I’d like to take this mo­ment to em­pha­size that this is a two-dose vac­cine and it is im­por­tant to re­ceive the sec­ond dose in the se­ries.”

As part of BAR­DA’s Ju­ly con­tract for 5 mil­lion vials of Jyn­neos, Bavar­i­an Nordic agreed to al­low a US-based man­u­fac­tur­er to fill and fin­ish 2.5 mil­lion vials.

“We con­tin­ue to build on our ef­forts to se­cure and make safe and ef­fec­tive vac­cines read­i­ly avail­able,” HHS Sec­re­tary Xavier Be­cer­ra said in a state­ment. “This new agree­ment so­lid­i­fies a do­mes­tic man­u­fac­tur­ing ca­pa­bil­i­ty that will bring us more vac­cine soon­er to end this out­break.”

Mean­while, BAR­DA struck a deal with Chimerix for up to 1.7 mil­lion dos­es of its small­pox treat­ment Tem­bexa. An ini­tial $115 mil­lion will grant the US gov­ern­ment 319,000 dos­es, but the 10-year con­tract has ad­di­tion­al op­tions worth an­oth­er $551 mil­lion, plus post-mar­ket­ing ac­tiv­i­ties worth $13 mil­lion. Over­all, the con­tract is worth up to $680 mil­lion.

Back in May, Chimerix agreed to sell its Tem­bexa rights to Emer­gent BioSo­lu­tions, which has of­fered $225 mil­lion up­front and mile­stones that could reach $100 mil­lion.

How­ev­er, the clos­ing of that deal is de­pen­dent on “BAR­DA’s ap­proval of a pre-no­va­tion agree­ment be­tween Chimerix and EBS,” ac­cord­ing to a news re­lease.

“Our col­lab­o­ra­tion with BAR­DA for the de­vel­op­ment of TEM­BEXA has pro­vid­ed the Unit­ed States gov­ern­ment with a sec­ond ther­a­peu­tic op­tion to en­sure the fed­er­al gov­ern­ment’s readi­ness for a po­ten­tial small­pox emer­gency,” Chimerix CEO Mike Sher­man said.

While there’s no treat­ment ap­proved for mon­key­pox in the US, an­tivi­rals such as Tem­bexa and Siga’s Tpoxx may be used, ac­cord­ing to the NIH.

The US is al­so ramp­ing up ship­ments of Siga’s Tpoxx treat­ment which was shown to clear 10 of 25 mon­key­pox pa­tients’ le­sions by day 7, and 23 pa­tients’ le­sions by day 21, ac­cord­ing to da­ta pub­lished by JA­MA

In the hopes of stretch­ing the US sup­ply of Jyn­neos, the FDA a cou­ple of weeks ago cleared most peo­ple for in­tra­der­mal in­jec­tions, which are more dif­fi­cult to ad­min­is­ter cor­rect­ly but re­quire much less vac­cine. While of­fi­cials claimed the new route of ad­min­is­tra­tion would ex­pand sup­ply by five-fold, vac­cine clin­ics have re­port­ed­ly strug­gled to squeeze a full five dos­es out of each vial.

Dur­ing the press brief­ing, White House mon­key­pox re­sponse co­or­di­na­tor Robert Fen­ton said clin­ics are ex­tract­ing be­tween 4.5 to 5 dos­es per vial.

So far, 1.1 mil­lion vials of vac­cine have been made avail­able, and 75% of ju­ris­dic­tions are ad­min­is­ter­ing dos­es in­tra­der­mal­ly while about 20% are work­ing to get there, Fen­ton said. As of Aug, 23, 207,000 dos­es had been ad­min­is­tered.

This sto­ry has been up­dat­ed to clar­i­fy that the Chimerix deal is in­tend­ed to pre­pare for a po­ten­tial small­pox emer­gency. 

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.