Am­gen adds new NC plant to the list as part of $1B man­u­fac­tur­ing ex­pan­sion plans state­side

What can $1 bil­lion buy? If you’re Am­gen, it’s good for two man­u­fac­tur­ing fa­cil­i­ties in the US.

The Cal­i­for­nia-based drug gi­ant will in­vest close to $550 mil­lion in a drug sub­stance plant in Hol­ly Springs, NC, adding it­self to an ever-grow­ing list of biotech com­pa­nies that have de­cid­ed to call North Car­oli­na home, and mark­ing its sec­ond drug man­u­fac­tur­ing an­nounce­ment in a lit­tle more than a month.

Am­gen pre­vi­ous­ly an­nounced an ex­pan­sion in Ohio, along with an agree­ment with Ohio State Uni­ver­si­ty to cre­ate an ex­pe­ri­en­tial learn­ing pro­gram, to­ward the end of June. But the news of its Hol­ly Springs, NC in­vest­ment snuck in­to its Q2 earn­ings re­port Tues­day.

“In an­tic­i­pa­tion of fu­ture de­mand for our med­i­cines, we will in­vest ap­prox­i­mate­ly $1 bil­lion to build two new man­u­fac­tur­ing fa­cil­i­ties – a pack­ag­ing plant in Ohio and a drug sub­stance plant in North Car­oli­na,” the re­lease said. “Both of these fa­cil­i­ties will be built faster and at a low­er cost than tra­di­tion­al plants, and both al­so will uti­lize cut­ting-edge tech­nolo­gies to be more ef­fi­cient and en­vi­ron­men­tal­ly friend­ly than tra­di­tion­al plants.”

Am­gen did not re­spond to a re­quest for com­ment Wednes­day.

The North Car­oli­na fa­cil­i­ty will cre­ate more than 350 jobs and is set to be op­er­a­tional by 2025, the com­pa­ny said. Con­struc­tion will start in 2021 and be com­plet­ed by 2029, and new hires will in­clude en­gi­neers, tech­ni­cians, qual­i­ty, man­age­ment and ad­min­is­tra­tive roles.

In­cen­tives in­clude a job de­vel­op­ment grant from the state worth around $12.6 mil­lion, and an­oth­er $22.8 mil­lion in in­cen­tives from Wake Coun­ty and the Hol­ly Springs lo­cal gov­ern­ment. The grants are con­tin­gent up­on hir­ing and in­vest­ment mile­stones. The av­er­age salary of the new po­si­tions added is ex­pect­ed to reach near­ly $120,000, close to dou­ble what the cur­rent av­er­age is in Wake Coun­ty.

“World-class com­pa­nies like Am­gen are very se­lec­tive when they eval­u­ate busi­ness lo­ca­tions and they on­ly choose places that pro­vide the best sup­port for their op­er­a­tions,” Gov. Roy Coop­er said in a press re­lease. “To­day’s de­ci­sion proves once again that North Car­oli­na re­mains a pre­mier lo­ca­tion for the most in­no­v­a­tive biotech com­pa­nies in the in­dus­try.”

Fu­ji­film Diosynth joined the ex­pan­sion par­ty in Hol­ly Springs in March with the an­nounce­ment of a $2 bil­lion plant of its own. A month ear­li­er, Gilead opened an of­fice for fi­nance, IT and hu­man re­sources op­er­a­tions in the area.

Am­gen’s ex­pan­sion marks the 47th life sci­ences project to come to North Car­oli­na since 2017, Coop­er said in an event.

San­dra Ro­driguez-Tole­do

“Cam­bridge and Boston bet­ter look out be­cause North Car­oli­na is com­ing,” Coop­er said.

Robert Keny­on, Am­gen’s VP of man­u­fac­tur­ing, will be the site lead for the new fa­cil­i­ty. He told the N&O that Am­gen will be the first ten­ant in the Friend­ship In­no­va­tion Park and that the site will have sin­gle-use tech­nol­o­gy, which pro­vides flex­i­bil­i­ty to man­u­fac­ture dif­fer­ent drugs.

“We are ex­cit­ed to be mak­ing this in­vest­ment in Hol­ly Springs and be­com­ing an im­por­tant part of the com­mu­ni­ty,” Keny­on said in a re­lease. “Be­yond be­ing a vi­brant busi­ness en­vi­ron­ment, the area of­fers a skilled, trained, and di­verse tal­ent pool that we know will help Am­gen main­tain its long his­to­ry of serv­ing pa­tients.”

Am­gen is al­so in­vest­ing $365 mil­lion in­to a new man­u­fac­tur­ing plant in New Al­bany, OH, 18 miles north­east of Colum­bus, to fur­ther its as­sem­bly and pack­ag­ing ca­pa­bil­i­ties. That site will be 270,000 square feet, and be housed in the New Al­bany In­ter­na­tion­al Busi­ness Park. VP of site op­er­a­tions San­dra Ro­driguez-Tole­do will move from Puer­to Ri­co to Ohio to over­see the new fa­cil­i­ty.

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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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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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

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.