Paul Chaplin, Bavarian Nordic CEO

Eu­rope to buy 110k dos­es of Bavar­i­an Nordic's mon­key­pox vac­cine — as EU-li­censed vac­cine not eas­i­ly ac­ces­si­ble

Known mon­key­pox cas­es rose above the 4,000 mark this week as of­fi­cials have sought an­oth­er name for the dis­ease, and Eu­ro­peans moved for­ward on stock­ing up a work­ing vac­cine.

The Eu­ro­pean Med­i­cines Agency an­nounced Mon­day that it had agreed to buy 110,000 dos­es of Jyn­neos, the US-li­censed ver­sion of Bavar­i­an Nordic’s Im­vanex. Im­vanex is au­tho­rized in the EU for the pre­ven­tion of small­pox in adults, but on­ly “un­der ex­cep­tion­al cir­cum­stances due to the im­pos­si­bil­i­ty to gen­er­ate ef­fi­ca­cy da­ta as small­pox virus is no longer cir­cu­lat­ing.”

Jyn­neos, on the oth­er hand, is ap­proved in the US and Cana­da for in­fec­tion and dis­ease caused by both small­pox and mon­key­pox. Both of these virus­es are or­thopoxvirus­es and are close­ly re­lat­ed.

“Since the EU au­tho­rised vac­cine Im­vanex is not im­me­di­ate­ly avail­able, in or­der to al­low rapid con­tain­ment of the out­breaks, EU MSs [mem­ber states] agreed to the pur­chas­ing of close to 110.000 dos­es of the US made vac­cine Jyn­neos by HERA. Their de­liv­ery is fore­seen to start to MSs with high­est num­ber of cas­es in the com­ing days,” the agency said in a state­ment.

The EMA on Mon­day said it al­so kicked off its re­view of da­ta to ex­tend the use of the small­pox vac­cine Im­vanex to in­clude pro­tect­ing peo­ple from mon­key­pox.

Bavar­i­an Nordic has been busy mak­ing deals with nu­mer­ous en­ti­ties such as the US gov­ern­ment’s BAR­DA for 500,000 dos­es and Ger­many for 40,000 dos­es, amid re­port­ing “over­whelm­ing in­ter­est” in Jyn­neos from oth­er en­ti­ties.

“We are ob­vi­ous­ly still in di­a­logue with a num­ber of coun­tries from dif­fer­ent re­gions of the world and we are ex­pect­ing to sign more con­tracts,” CFO Hen­rik Ju­uel said ear­li­er this month on an in­vestor call.

Jyn­neos is pro­duced at Bavar­i­an Nordic’s man­u­fac­tur­ing fa­cil­i­ty in Den­mark, which is not cur­rent­ly au­tho­rized for EU pro­duc­tion, ac­cord­ing to the EMA. At least in the man­u­fac­tur­ing process, the dif­fer­ence be­tween Jyn­neos and Im­vanex was not con­sid­er­able, and “[d]if­fer­ences are deemed to be mi­nor and do not raise any con­cern re­gard­ing im­mu­ni­sa­tion with Jyn­neos,” the agency added.

One oth­er fac­tor brought up was shelf life — Jyn­neos can store for three years at -20 ̊C, or -4 ̊F. How­ev­er, Im­vanex is on­ly au­tho­rized for two years at that same tem­per­a­ture, plus dif­fer­ing shelf life be­tween the two when thawed and stored in sim­i­lar con­di­tions. And while ini­tial da­ta seem that the two vac­cines could have the same shelf life of three years when frozen, the EMA not­ed that in­for­ma­tion is not com­plete­ly avail­able to con­firm the same amount of po­ten­cy.

Re­gard­less, the agency adds, “It is ac­cept­able to use Jyn­neos un­der the stat­ed EU stor­age con­di­tions for Im­vanex as a tem­po­rary mea­sure un­til the EU and US da­ta sets are aligned.”

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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