Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Pfiz­er and BioN­Tech team up with South African man­u­fac­tur­er, but it will on­ly han­dle fill-fin­ish

The man­u­fac­tur­ing ex­pan­sion in­to Africa con­tin­ued Wednes­day with Pfiz­er and BioN­Tech’s an­nounce­ment that the two com­pa­nies signed on with the Bio­vac In­sti­tute to man­u­fac­ture its Covid-19 vac­cine to dis­trib­ute through­out Africa. But while the con­ti­nent is in dire need of dos­es, vac­cines from the ex­pan­sion won’t be avail­able un­til the start of next year.

Bio­vac will on­ly han­dle dis­tri­b­u­tion and fill-fin­ish du­ties. Drug sub­stance for these batch­es will come from Eu­ro­pean fa­cil­i­ties. When ful­ly op­er­a­tional, the fa­cil­i­ty will pump out 100 mil­lion dos­es a year, set to be even­ly dis­trib­uted among the 55 mem­ber states of the African Union.

The an­nounce­ment marks the fourth con­ti­nent that the vac­cine will be man­u­fac­tured in, at over 20 fa­cil­i­ties. Tech­ni­cal trans­fer, on-site de­vel­op­ment and equip­ment in­stal­la­tions are all al­ready un­der­way, Pfiz­er said.

As the con­ti­nent has been left be­hind in the race be­tween coun­tries to in­oc­u­late its res­i­dents, drug­mak­ers have made moves to play catch-up, par­tic­u­lar­ly af­ter be­ing spooked by Pres­i­dent Joe Biden’s de­c­la­ra­tion that his ad­min­is­tra­tion sup­port­ed vac­cine in­tel­lec­tu­al prop­er­ty waivers. Mod­er­na’s on­ly in­volve­ment in Africa has come in the form of a dis­tri­b­u­tion agree­ment with Dubai-based Ma­gen­ta In­vest­ments, a com­pa­ny which has deal­ings in both the Mid­dle East and Africa. In March, J&J made 220 mil­lion dos­es of the shot avail­able to the African Vac­cine Ac­qui­si­tion Trust, but no an­nounce­ments sur­round­ing man­u­fac­tur­ing have been made.

The WHO and CDC have both thrown sup­port at a South African con­sor­tium to es­tab­lish a Covid-19 mR­NA vac­cine tech­nol­o­gy trans­fer hub that will, in the­o­ry, al­low for the shar­ing of IP to train man­u­fac­tur­ers and learn the process.

But the de­mand for dos­es is ur­gent; near­ly all vac­cines used in Africa are im­port­ed and on­ly about 1% of peo­ple on the con­ti­nent have been ful­ly vac­ci­nat­ed. The Covid-19 pan­dem­ic isn’t the first time Africa has been ne­glect­ed by the phar­ma­ceu­ti­cal in­dus­try, but it’s the lat­est ex­am­ple.

“As we and many oth­ers have long said, shar­ing Covid-19 tech and man­u­fac­tur­ing is on­ly way to move to­ward eq­ui­ty. huge un-tapped African ca­pac­i­ty and ex­per­tise,” George­town glob­al health pro­fes­sor Matthew Ka­vanagh tweet­ed Wednes­day. “Past time to use state pow­er to com­pel shar­ing. To­day, com­pa­nies show they will not do right with­out it.”

The con­tract was award­ed to the Bio­vac In­sti­tute af­ter a se­lec­tion process that fac­tors in com­pli­ance, qual­i­ty and safe­ty track record, among oth­er things. Pfiz­er has worked with Bio­vac since 2015, when the two joined forces for fill-fin­ish du­ties and dis­tri­b­u­tion of Pre­ve­nar 13, an in­tra­mus­cu­lar­ly in­ject­ed jab to pre­vent in­fec­tions such as pneu­mo­nia and menin­gi­tis.

“From day one, our goal has been to pro­vide fair and eq­ui­table ac­cess of the Pfiz­er-BioN­Tech COVID-19 Vac­cine to every­one, every­where,” Pfiz­er CEO Al­bert Bourla said in a state­ment. “Our lat­est col­lab­o­ra­tion with Bio­vac is a shin­ing ex­am­ple of the tire­less work be­ing done, in this in­stance to ben­e­fit Africa. We will con­tin­ue to ex­plore and pur­sue op­por­tu­ni­ties to bring new part­ners in­to our sup­ply chain net­work, in­clud­ing in Latin Amer­i­ca, to fur­ther ac­cel­er­ate ac­cess of COVID-19 vac­cines.”

Pfiz­er-BioN­Tech’s jab is still await­ing full ap­proval from the FDA. It’s cur­rent­ly avail­able un­der the Emer­gency Use Au­tho­riza­tion.

In May, the EU backed an ef­fort to ex­pand man­u­fac­tur­ing in Africa. Three lo­ca­tions were be­ing con­sid­ered, in­clud­ing the In­sti­tut Pas­teur in Sene­gal, and in Rwan­da and South Africa.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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

BREAK­ING: 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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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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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.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

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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.

Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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