Kenya wins $500M sweep­stakes for Mod­er­na's first African man­u­fac­tur­ing site

Af­ter a long wait, Mod­er­na now has a home for its first man­u­fac­tur­ing site in Africa.

The biotech en­tered a mem­o­ran­dum of un­der­stand­ing with the Kenyan gov­ern­ment to fi­nal­ize the coun­try as the site for the coun­try’s first man­u­fac­tur­ing op­er­a­tions on the con­ti­nent. Mod­er­na will in­vest $500 mil­lion in the new site that will first fo­cused on drug sub­stance man­u­fac­tur­ing, and can lat­er be ex­pand­ed to in­clude fill-fin­ish and pack­ag­ing on site.

The site will have the ca­pa­bil­i­ties to pro­duce 500 mil­lion dos­es to Africa each year. The site can al­so ben­e­fit mR­NA can­di­dates that are be­ing de­vel­oped to treat HIV and Ni­pah Virus, a vi­ral in­fec­tion that can pass through con­t­a­m­i­nat­ed foods or an­i­mals.

“We are pleased to part­ner with Mod­er­na in the es­tab­lish­ment of this mR­NA man­u­fac­tur­ing fa­cil­i­ty to help pre­pare the coun­try and our sis­ter states on the con­ti­nent through the African Union to re­spond to fu­ture health crises and stave off the next pan­dem­ic,” Kenyan Pres­i­dent Uhu­ru Keny­at­ta said in a state­ment. “This part­ner­ship is a tes­ta­ment to the ca­pa­bil­i­ties of our com­mu­ni­ty and our com­mit­ment to tech­no­log­i­cal in­no­va­tion. Mod­er­na’s in­vest­ment in Kenya will help ad­vance eq­ui­table glob­al vac­cine ac­cess and is em­blem­at­ic of the struc­tur­al de­vel­op­ments that will en­able Africa to be­come an en­gine of sus­tain­able glob­al growth.”

The news comes af­ter months of pub­lic scruti­ny. CEO Stéphane Ban­cel an­nounced at the be­gin­ning of Oc­to­ber that his com­pa­ny would in­vest half a bil­lion dol­lars in­to a plant some­where in Africa, though it didn’t dis­close any fur­ther de­tails, in­clud­ing where ex­act­ly on the con­ti­nent it would be lo­cat­ed.

Mod­er­na is among a num­ber of biotechs that faced crit­i­cism for its vac­cine shar­ing from ad­vo­ca­cy groups, such as Pub­lic Cit­i­zen and mem­bers from Pres­i­dent Joe Biden’s ad­min­is­tra­tion, who ques­tioned why the num­ber of dos­es pledged to low­er- and mid­dle-in­come coun­tries are much low­er than oth­er com­pa­nies. An in­ves­ti­ga­tion from the New York Times found that 1 mil­lion of Mod­er­na’s dos­es have gone to coun­tries clas­si­fied as low-in­come by the World Bank, com­pared with 8.4 mil­lion from Pfiz­er and 25 mil­lion from J&J. That, Ban­cel said in a 2021 in­ter­view with End­points News, can be – in part – chalked up to the dis­par­i­ty in the size of the com­pa­nies.

The two sides will get help from the US gov­ern­ment. In Sep­tem­ber 2021, the US State De­part­ment do­nat­ed 880,320 dos­es of Mod­er­na’s Covid-19 vac­cine to Kenya in col­lab­o­ra­tion with the African Union and Co­v­ax pro­gram. Mod­er­na’s mR­NA pipeline in­cludes 28 vac­cine pro­grams in the pro­phy­lac­tic modal­i­ty for threats to pub­lic health, the com­pa­ny said in a re­lease. The com­pa­ny’s can­di­date mR­NA-1893 is in Phase II tri­als to treat the Zi­ka virus and it is ex­plor­ing treat­ment op­tions for yel­low fever. Once the pan­dem­ic eas­es up, Mod­er­na will be able to switch swift­ly from man­u­fac­tur­ing one drug to an­oth­er, such as from the Zi­ka vac­cine to a flu shot.

BioN­Tech is, so far, the on­ly oth­er biotech to lay out con­crete plans sur­round­ing the long-term use for mR­NA on the African con­ti­nent. The Ger­man com­pa­ny said it would tran­si­tion to mak­ing malar­ia drugs once the pan­dem­ic is un­der con­trol.

The biotech is al­so push­ing to get dos­es of its Covid-19 vac­cine filled in Africa by 2023, so long as the de­mand is there.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

Endpoints Premium

Premium subscription required

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

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

Endpoints Premium

Premium subscription required

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

Graphic: Shutterstock

Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Big Phar­mas team up with lo­cal Sin­ga­pore or­ga­ni­za­tions to boost man­u­fac­tur­ing

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.

Enhertu researcher Ian Krop speaks during Wednesday's SABCS press conference (MedMeetingImages/Todd Buchanan via SABCS)

SABCS roundup: No­var­tis shows two-year PFS in breast can­cer sub­groups; As­traZeneca re­veals more En­her­tu da­ta

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.