Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

As con­ti­nen­t's vac­ci­na­tion rate sits be­low 5%, Mod­er­na an­nounces in­vest­ment in mR­NA man­u­fac­tur­ing in Africa

Af­ter mount­ing pres­sure from com­peti­tors, Mod­er­na has signed on to in­vest $500 mil­lion in an mR­NA man­u­fac­tur­ing site in Africa that could make up to 500 mil­lion dos­es a year.

It’s a move in­to a re­gion that has been large­ly ne­glect­ed his­tor­i­cal­ly by Big Phar­ma, a trend that’s held strong through­out the Covid-19 pan­dem­ic. The Mo­roc­can gov­ern­ment re­cent­ly dropped $500 mil­lion in­to a new Re­ci­pharm fill-fin­ish plant, and Gri­fols is build­ing an IV bag plant in Nige­ria, but those projects aren’t set to be up and run­ning un­til 2023 and 2024, re­spec­tive­ly.

Just about 4.4% of all Africans have been ful­ly vac­ci­nat­ed for Covid-10, ac­cord­ing to the World Health Or­ga­ni­za­tion.

The site will pro­duce up to 500 mil­lion dos­es at the 50 µg dose lev­el, and the fa­cil­i­ty will in­clude drug sub­stance man­u­fac­tur­ing on top of fill-fin­ish and pack­ag­ing ca­pa­bil­i­ties. Mod­er­na will next have to fo­cus on se­lect­ing a site for the fa­cil­i­ty. This fits in to Mod­er­na’s re­cent­ly an­nounced rapid ramp-up strat­e­gy.

“On be­half of our grow­ing team, part­ners and share­hold­ers, we are de­ter­mined to ex­tend Mod­er­na’s so­ci­etal im­pact through the in­vest­ment in a state-of-the-art mR­NA man­u­fac­tur­ing fa­cil­i­ty in Africa,” CEO Stéphane Ban­cel said in a press re­lease Thurs­day. “While we are still work­ing to in­crease ca­pac­i­ty in our cur­rent net­work to de­liv­er vac­cines for the on­go­ing pan­dem­ic in 2022, we be­lieve it is im­por­tant to in­vest in the fu­ture. We ex­pect to man­u­fac­ture our COVID-19 vac­cine as well as ad­di­tion­al prod­ucts with­in our mR­NA vac­cine port­fo­lio at this fa­cil­i­ty.”

The move comes as Mod­er­na has re­sist­ed pres­sure from the White House to up pro­duc­tion and do­na­tions of the Covid-19 shot. Pres­i­dent Joe Biden’s ad­min­is­tra­tion has urged Mod­er­na for months to up pro­duc­tion do­mes­ti­cal­ly, and at least one of­fi­cial told Politi­co that it be­lieves that the re­luc­tance has been dri­ven by the threat of sell­ing the jabs at-cost.

The US gov­ern­ment dumped $200 mil­lion over the sum­mer in­to a South African plant to en­sure that Africans had ac­cess to J&J’s vac­cines. But in Au­gust, The New York Times re­port­ed that many of those dos­es had been ex­port­ed back to Eu­rope. At that time, just 2% of Africans were vac­ci­nat­ed, com­pared to more than 60% of adults in Eu­rope. J&J’s jab was par­tic­u­lar­ly cru­cial in Africa be­cause it’s a sin­gle shot, mak­ing it eas­i­er for peo­ple in rur­al ar­eas to get ful­ly in­oc­u­lat­ed.

The African Union has or­dered 400 mil­lion dos­es of vac­cines for the coun­tries with­in it, but few have been de­liv­ered.

The an­nounce­ment comes months af­ter BioN­Tech, its big com­peti­tor in the mR­NA space, an­nounced it would piv­ot the fo­cus of its new man­u­fac­tur­ing sites in Africa from Covid-19 treat­ments to malar­ia when the time be­came right, and a day af­ter the WHO ap­proved Glax­o­SmithK­line’s malar­ia vac­cine.

The com­pa­ny’s pipeline has 20 vac­cine can­di­dates, in­clud­ing a BAR­DA-fund­ed Zi­ka vac­cine that is in Phase II, a com­bi­na­tion Covid-19 and flu vac­cine and an HIV jab that is cur­rent­ly in pre­clin­i­cal de­vel­op­ment.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.