Mas­sive $1.5B in­vest­ment in man­u­fac­tur­ing widens Eli Lil­ly's foot­print in Ire­land and North Car­oli­na

What do North Car­oli­na and Ire­land have in com­mon? A tra­di­tion of friend­ly peo­ple, a deep ap­pre­ci­a­tion of brew­eries, and now, new Eli Lil­ly man­u­fac­tur­ing sites, set to hire 900 peo­ple.

In­di­anapo­lis-based Eli Lil­ly will pump al­most $1.5 bil­lion in­to the two new man­u­fac­tur­ing fa­cil­i­ties, the com­pa­ny an­nounced on Fri­day. The short-term fo­cus of these plants will be to bol­ster di­a­betes and can­cer prod­ucts, while the sites will take on Alzheimer’s and obe­si­ty med­ica­tions in the long run.

In Lim­er­ick, Ire­land, a $446 mil­lion in­vest­ment will ex­pand the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent and mon­o­clon­al an­ti­body pro­duc­tion. In Con­cord, NC, about 25 miles from Char­lotte, a $1 bil­lion project will fo­cus on in­jecta­bles and med­ical de­vices. This means that in the last five years, Lil­ly has pumped $4 bil­lion in­to glob­al man­u­fac­tur­ing, in­clud­ing $2 bil­lion in the US.

The lo­cal gov­ern­ments for both cities have of­fered tremen­dous help through­out the process, pres­i­dent of man­u­fac­tur­ing Ed Her­nan­dez said in a call with End­points News Fri­day.

Both lo­cal­i­ties of­fered tax in­cen­tives to grow in their re­spec­tive re­gions, though the specifics were not dis­closed. This is the sec­ond new site to be built in North Car­oli­na in the past two years, as plans for a Re­search Tri­an­gle Park site were an­nounced in 2020. Con­struc­tion is well along at that site, and the com­pa­ny has al­ready hired about 100 peo­ple.

The com­pa­ny has brought 16 new prod­ucts to mar­ket in the last eight years, and it plans to bring an­oth­er five in the next two years, in­clud­ing the obe­si­ty drug tirzepatide and the ear­ly Alzheimer’s treat­ment do­nanemab.

“It’s a good sign when we need to build new man­u­fac­tur­ing fa­cil­i­ties, be­cause it means you’re ei­ther de­vel­op­ing new med­ica­tions, or the med­ica­tions that you’ve got out in the mar­ket are help­ing more peo­ple, and you need to make more,” Mike Ma­son, head of Lil­ly di­a­betes, said. “For us, it’s a com­bi­na­tion of both.”

Rough­ly 600 peo­ple will be hired in North Car­oli­na, and an­oth­er 300 in Ire­land. Both re­gions have a strong pool of tal­ent, and Lil­ly has con­nec­tions with lo­cal in­sti­tu­tions. In North Car­oli­na, the re­la­tion­ships are with com­mu­ni­ty col­leges in the area, as well as NC State and the Uni­ver­si­ty of North Car­oli­na-Char­lotte. In Ire­land, that con­nec­tion is pri­mar­i­ly with the Uni­ver­si­ty of Lim­er­ick.

“Mak­ing med­i­cine, it’s a com­plex busi­ness. So we’re hir­ing en­gi­neers, sci­en­tists, phar­ma­cists, qual­i­ty con­trol staff, lab tech­ni­cians and op­er­a­tors,” Her­nan­dez said. “The fact that we have good re­la­tion­ships with lo­cal uni­ver­si­ties, that’s key in help­ing us get­ting the peo­ple we need to get.”

It’s an­oth­er huge get for North Car­oli­na Gov. Roy Coop­er, who has been of­fer­ing in­cen­tives for com­pa­nies to add man­u­fac­tur­ing op­er­a­tions in the state over the course of the last year.

“Lil­ly’s choice brings more good jobs to North Car­oli­na from one of our most im­por­tant in­dus­tries,” he said in a state­ment. “North Car­oli­na has be­come a pre­mier hub for the world, thanks to our ex­cep­tion­al work­force and com­mit­ment to ed­u­ca­tion.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

GSK is continuing to build out its Barnard Castle site in the UK.

According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.

The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.

The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.