To fill African man­u­fac­tur­ing void, BioN­Tech will pig­gy­back off plans for malar­ia mR­NA vac­cine with new man­u­fac­tur­ing sites

The lack of drug man­u­fac­tur­ing in Africa has led to a need for Covid-19 vac­cines, and the lack of a malar­ia vac­cine has led to the deaths of thou­sands of chil­dren each year. BioN­Tech will now to try and take down two birds with one stone.

BioN­Tech is ex­plor­ing pos­si­bil­i­ties to set up mR­NA man­u­fac­tur­ing fa­cil­i­ties through­out the con­ti­nent, ei­ther by part­ner­ing with oth­er com­pa­nies or through its own vo­li­tion, the com­pa­ny an­nounced in a press re­lease. These fa­cil­i­ties would have mR­NA man­u­fac­tur­ing ca­pa­bil­i­ties, and will share space with tech­nol­o­gy trans­fer hubs that are un­der de­vel­op­ment by the World Health Or­ga­ni­za­tion that line up with the strat­e­gy cre­at­ed by the Africa CDC.

BioN­Tech and its Covid-19 vac­cine part­ner Pfiz­er hopped on­board with an African man­u­fac­tur­er last week, an­nounc­ing they had part­nered with the Bio­vac In­sti­tute to man­u­fac­ture vac­cines to dis­trib­ute through­out Africa. On­ly 60 mil­lion dos­es have been doled out to the pop­u­la­tion of 1.3 bil­lion on the con­ti­nent.

The move is aimed at in­creas­ing the ac­ces­si­bil­i­ty of vac­cines to low- and mid­dle-in­come coun­tries through an end-to-end process that sup­ports scal­ing.

“Our ef­forts will in­clude cut­ting-edge re­search and in­no­va­tion, sig­nif­i­cant in­vest­ments in vac­cine de­vel­op­ment, the es­tab­lish­ment of man­u­fac­tur­ing fa­cil­i­ties, and the trans­fer of man­u­fac­tur­ing ex­per­tise to pro­duc­tion sites on the African con­ti­nent and wher­ev­er else it is need­ed,” CEO Ugur Sahin said in a press re­lease.

Ger­man biotech BioN­Tech burst on­to the main­stream stage when its Covid-19 vac­cine was grant­ed an EUA. That was the first BioN­Tech can­di­date to ad­vance in­to com­mer­cial stage. Now, it has an­nounced an mR­NA pro­gram for malar­ia that will lead to the com­pa­ny trans­fer­ring the tech to oth­er com­pa­nies. The vac­cine will aim to fill a huge void, with the Glax­o­SmithK­line shot Mo­suir­ix — a drug that boasts ef­fi­ca­cy of 30% — the on­ly oth­er op­tion avail­able.

More than 400,000 peo­ple die of malar­ia each year, most­ly on the African con­ti­nent. Chil­dren un­der the age of 5 ac­count­ed for 67%, about 274,000 of the world’s malar­ia deaths. In 2019, 94% of the malar­ia cas­es and deaths re­port­ed in the world came from Africa.

Through uti­liz­ing mR­NA tech­nol­o­gy, BioN­Tech hopes to en­sure the mR­NA man­u­fac­tur­ing sites will have a long life­time. The com­pa­ny says it has the po­ten­tial to cre­ate a new mod­el for gen­er­at­ing vac­cines in bulk to de­vel­op­ing coun­tries.

The Pfiz­er-BioN­Tech col­lab­o­ra­tion with Bio­vac stirred up some con­tro­ver­sy from crit­ics who didn’t ap­prove of the fa­cil­i­ty’s re­liance on APIs com­ing from Eu­rope. Bio­vac will on­ly han­dle fill-fin­ish and dis­tri­b­u­tion du­ties. The move does not al­low Bio­vac to gain ac­cess to the IP to make the vac­cine, de­spite the best ef­forts by South African politi­cians and pub­lic health of­fi­cials to put to­geth­er pro­duc­tion ca­pac­i­ty.

“As we and many oth­ers have long said, shar­ing Covid-19 tech and man­u­fac­tur­ing is on­ly way to move to­ward eq­ui­ty. Huge un­tapped African ca­pac­i­ty and ex­per­tise,” tweet­ed Matthew Ka­vanagh, a George­town pub­lic health pro­fes­sor.

African na­tions have strug­gled to in­oc­u­late their cit­i­zens through­out the pan­dem­ic large­ly due to vac­cine shar­ing and do­na­tion ini­tia­tives such as CO­V­AX fail­ing to gar­ner enough sup­plies. CEO of As­pen Phar­ma­ceu­ti­cals Stephen Saad said in an in­ter­view with CNN that more than 90% of the con­ti­nent’s vac­cines are im­port­ed, and most of those came from In­dia. When In­dia was hit with its dead­ly sec­ond wave, Africa’s vac­cine sup­ply dwin­dled.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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With plans to spend $360M, As­traZeneca will build its first-ever man­u­fac­tur­ing site in Ire­land

AstraZeneca is planning to spend a pretty penny for a new manufacturing facility in Dublin.

The Big Pharma will shell out $360 million to build an API plant for small molecules at its Alexion campus in College Park, Dublin, it announced Tuesday morning. AstraZeneca said the focus of the facility will be late-stage development and early commercial supply for small molecule therapies.

“The future manufacturing of APIs for our medicines includes compounds with highly complex synthesis, requiring next generation technologies and capabilities that can respond quickly and nimbly to rapidly-changing clinical and commercial needs,” AstraZeneca global ops chief Pam Cheng said in a statement. “This significant investment will ensure the AstraZeneca supply network is fit for the future.”

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).