(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Ris­ing mon­key­pox cas­es have put the US on high alert as it an­nounces a na­tion­al health emer­gency, which grants the gov­ern­ment more pow­er in its re­sponse.

The news comes as Bavar­i­an Nordic con­tin­ues to fill or­ders for its Jyn­neos vac­cine and oth­er com­pa­nies – in­clud­ing Mod­er­na – con­sid­er jump­ing in­to the vac­cine race. Mean­while, the New York Times re­ports that the US has al­lowed around 20 mil­lion dos­es of small­pox vac­cine in its stock­pile to ex­pire.

Stephen Hoge, head of R&D ef­forts at Mod­er­na, said in the com­pa­ny’s Q2 call that the com­pa­ny has kicked off a re­search pro­gram and is track­ing that ef­fort close­ly.

Stephen Hoge

“Ob­vi­ous­ly giv­en the re­cent pub­lic health an­nounce­ments and in­creas­ing con­cern about the avail­abil­i­ty of vac­cine sup­ply, we are be­gin­ning to look at what it would take for us to use our plat­form to pro­vide a mon­key­pox vac­cine,” Hoge said on the call, adding that the pro­gram is still in pre­clin­i­cal de­vel­op­ment.

Mean­while, Tonix Phar­ma­ceu­ti­cals, which has been re­search­ing a mon­key­pox vac­cine for near­ly a decade, will “look at ex­pe­dit­ing” its US de­vel­op­ment plans “in light of the HHS de­c­la­ra­tion,” CEO Seth Le­d­er­man told End­points News short­ly af­ter the US de­clared a pub­lic health emer­gency.

Last week, the biotech said it would test its live virus vac­cine in col­lab­o­ra­tion with Kenya Med­ical Re­search In­sti­tute in a clin­i­cal tri­al in the first half of 2023.

While the biotech could ramp up its time­line for test­ing in the US, Le­d­er­man cau­tioned that he doesn’t see an emer­gency use au­tho­riza­tion path­way for Tonix since Jyn­neos was al­ready ap­proved for mon­key­pox in 2019.

Bavar­i­an Nordic said ear­li­er this year that it has seen “over­whelm­ing” in­ter­est in its vac­cine Jyn­neos, in­clud­ing an ex­pand­ed deal with the US and most re­cent­ly, a new con­tract with an undis­closed Asia-Pa­cif­ic coun­try for 350,000 dos­es.

Paul Chap­lin

“While gov­ern­ments and health au­thor­i­ties around the world are busy fight­ing the cur­rent mon­key­pox out­break we ap­plaud those gov­ern­ments think­ing be­yond the cur­rent sit­u­a­tion and build­ing stock­piles to se­cure fu­ture pre­pared­ness and we are proud to as­sist our cus­tomers in both ef­forts,” Bavar­i­an Nordic CEO Paul Chap­lin said in a state­ment on Wednes­day.

Emer­gent is al­so look­ing to step up its re­sponse, telling End­points in an email that it has re­ceived in­quiries from gov­ern­ments and pub­lic health or­ga­ni­za­tions around its small­pox vac­cine ACAM2000.

“We are al­so aware that some gov­ern­ments and pub­lic health or­ga­ni­za­tions have stat­ed that our small­pox vac­cine could be used to com­bat the cur­rent mon­key­pox out­break. This is in­for­ma­tion gov­ern­ments and pub­lic health or­ga­ni­za­tions are shar­ing based on the sci­en­tif­ic da­ta they have avail­able,” the com­pa­ny said, adding that ACAM2000 isn’t specif­i­cal­ly ap­proved for mon­key­pox in the US or any­where else.

How­ev­er, HHS has pre­vi­ous­ly not­ed that ACAM2000 isn’t rec­om­mend­ed for every­one “due to sig­nif­i­cant side ef­fects.” NI­AID di­rec­tor An­tho­ny Fau­ci told Newsweek that ACAM can’t be tol­er­at­ed by peo­ple with cer­tain con­di­tions, in­clud­ing kids with eczema and those who are im­muno­com­pro­mised.

“By their very na­ture, med­ical coun­ter­mea­sures are most use­ful when pro­duced and made read­i­ly avail­able be­fore they are need­ed. For our part, we will con­tin­ue to sup­port pub­lic health pre­pared­ness plans by re­li­ably sup­ply­ing ACAM2000 and oth­er med­ical coun­ter­mea­sures to the U.S. and al­lied gov­ern­ments to com­bat a wide range of pub­lic health threats,” Emer­gent said.

“Ac­cord­ing to re­cent state­ments from gov­ern­ment of­fi­cials, more than 100 mil­lion dos­es of ACAM2000 are cur­rent­ly in the Strate­gic Na­tion­al Stock­pile. We have the ca­pac­i­ty to pro­duce more than 18 mil­lion dos­es of ACAM2000 per year and could in­crease pro­duc­tion to near­ly 40 mil­lion dos­es per year if need­ed,” the com­pa­ny added.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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