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.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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EQRx chairman Alexis Borisy and CEO Melanie Nallichieri

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

As a self-stylized drug pricing disruptor, EQRx has high hopes for its lead PD-(L)1 to offer proof of concept for the entire business model. After touting a win back in May, the biotech is back with full data in lung cancer that could back up an approval.

Patients dosed with EQRx and CStone Pharmaceuticals’ sugemalimab posted median progression-free survival of 9 months compared with 5.8 months for patients given placebo (p=0.0026), according to full data from the Phase III GEMSTONE-301 study in Stage III non-small cell lung cancer set to be presented at this weekend’s #ESMO21.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Patricio Massera, AGC Biologics CEO

AGC un­veils Ger­man ex­pan­sion plans as gene and cell ther­a­py man­u­fac­tur­ing com­pe­ti­tion heats up

AGC Biologics is significantly expanding a German site focusing on cell and gene therapies.

The Seattle company will add another cGMP manufacturing line at its Heidelberg facilities, which already feature 100-liter and 1,000-liter manufacturing capacities for microbial protein and cell and gene therapy. The site will add more warehouse capacity too, which AGC says will help the company prepare for the rapid increase in demand.

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Jonny Ohlson, Touchlight Genetics

DNA play­er Touch­light dou­bles fundrais­ing this year with lat­est round of pri­vate back­ers on board

When the news got out about Touchlight’s $60 million financing round in March, the most promising part of it all was the suggestion that the company could triple the production of its “doggybone” DNA and supply up to 1 billion Covid-19 shot doses per month.

Now, the company will have more than double that amount of money to work with.

The UK-based biotech that makes enzymatic DNA announced the extension of its fundraising round to a total of $125 million, the company announced. This comes at a time when demand for synthetic DNA has grown in the last year. Touchlight says the funding will help it become the largest synthetic DNA manufacturer in the world.

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