South African President Cyril Ramaphosa (L) and founder of NantWorks Patrick Soon-Shiong, right, cut the ribbon during the launch of NantSA, the future vaccine manufacturing campus in Brackengate, Cape Town, South Africa (Gianluigi Guercia/Pool Photo via AP)

Covid-19 man­u­fac­tur­ing roundup: New pro­duc­tion site opens in Africa; Sen­a­tor calls for test prices to be slashed

It looks like do­mes­tic man­u­fac­tur­ing of Covid-19 vac­cines is a step clos­er to re­al­i­ty for Africans af­ter a rib­bon cut­ting cer­e­mo­ny at the NantSA man­u­fac­tur­ing fa­cil­i­ty in Cape Town.

Patrick Soon-Sh­iong, a US bil­lion­aire who was born in South Africa, and Pres­i­dent Cyril Ramaphosa cut the rib­bon yes­ter­day at a plant large­ly fund­ed by Soon-Sh­iong.

“The COVID-19 pan­dem­ic has re­vealed the ex­tent of Africa’s health chal­lenges. The pan­dem­ic has re­vealed the huge dis­par­i­ties that ex­ist with­in and be­tween coun­tries in ac­cess to qual­i­ty health­care, med­i­cines, di­ag­nos­tics and vac­cines,” Ramaphosa said in a speech. “At the same time, the pan­dem­ic has re­vealed the depth of sci­en­tif­ic knowl­edge, ex­per­tise and ca­pac­i­ty on our con­ti­nent. It has shown what we are ca­pa­ble of when we work to­geth­er to mo­bi­lize all our re­sources to con­front a com­mon chal­lenge.”

The launch was al­so for the start of Ac­cel­er­ate Africa’s Ac­cess to Ad­vanced Health­care coali­tion. That aims to man­u­fac­ture a bil­lion dos­es of the vac­cine by 2025 and es­tab­lish an­oth­er man­u­fac­tur­ing site in sub-Sa­ha­ran Africa.

Even­tu­al­ly, the Cape Town site will al­so man­u­fac­ture drugs for can­cer treat­ments and oth­er phar­ma­ceu­ti­cals.

Ram­pa­hosa has pushed heav­i­ly for drug man­u­fac­tur­ers to waive in­tel­lec­tu­al prop­er­ty rights so a larg­er num­ber of coun­tries can place an or­der for vac­cines.

Africa has been left be­hind in many pub­lic health ef­forts, and the Covid-19 pan­dem­ic is no dif­fer­ent. At the end of Ju­ly, the first J&J shots pro­duced in South Africa en­tered arms — but those arms were not lo­cat­ed on the con­ti­nent but in Eu­rope as mil­lions of dos­es have been ex­port­ed.

Sen­a­tor calls for test prices to be slashed

Just days af­ter the US gov­ern­ment rolled out a plan to pro­vide Amer­i­cans with up to four free rapid anti­gen Covid-19 tests through the postal ser­vice, Sen. Ed Markey, D-MA. is call­ing for test man­u­fac­tur­ers and re­tail­ers to cut back on costs, and make the tests more af­ford­able.

Markey wrote to re­tail­ers like Ama­zon, CVS and Wal­mart, as well as a dozen man­u­fac­tur­ers, in­clud­ing Ab­bott, ask­ing for price in­for­ma­tion. In the let­ter, he high­lights a malar­ia test that is made by Ab­bott that sells for just 20 cents each, and says that the tech­nol­o­gy is sim­i­lar enough to sug­gest a low­er man­u­fac­tur­ing cost of the Covid-19 anti­gen tests.

“As we face an un­prece­dent­ed wave of COVID cas­es, man­u­fac­tur­ers and re­tail­ers must do more to en­sure con­sumers see rea­son­able prices for at-home tests,” Markey wrote. “Emer­gency rooms, in­ten­sive care units, and health sys­tems are over­whelmed across the coun­try due to the surge of COVID-19 cas­es. Ex­pand­ed ac­cess to af­ford­able at-home test­ing can help to al­le­vi­ate this strain on our health sys­tem.”

The tests can be made for as lit­tle as $2 each, ac­cord­ing to Mo­log­ic, a UK test mak­er.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Man­u­fac­tur­ing roundup: Phar­maron se­cures ac­qui­si­tion of a Rhode Is­land fa­cil­i­ty; GSK to open hub in South Amer­i­ca

A Chinese pharma company is growing its presence in the US with a newly acquired API manufacturing site.

Pharmaron has entered into a definitive agreement to acquire a Coventry, Rhode Island-based API manufacturing site from drug manufacturer Noramco, which was previously owned by Johnson & Johnson and now owned by the private equity firm SK Capital.

According to Pharmaron, the site has an established history of API manufacturing from pilot kilogram to commercial metric ton scales. However, according to The People’s Radio, an NPR station covering Rhode Island and parts of Massachusetts, the facility was formerly owned by a subsidiary of Purdue Pharmaceuticals called Rhodes Technologies and was known for making opioid products. According to that report, because of Purdue’s 2019 bankruptcy filing, the Coventry factory was sold to Noramco, another opioid ingredient manufacturer.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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