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.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Re­gen­eron's mAB gets ex­pand­ed EUA; mR­NA drug­mak­ers spike price of vac­cines in EU sup­ply deal

The FDA has expanded the authorization for Regeneron’s Covid-19 treatment Regen-Cov in an announcement Friday.

The authorization now covers post-exposure prophylaxis for those exposed to an infected person or who are at high risk of exposure “in an institutional setting” like a nursing home or a prison, and are not fully vaccinated or expected to provide a sufficient immune response.

Regeneron experts predict that 3% of the US population may not be able to fully respond to Covid-19 vaccinations.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.