Gilead plans to in­vest $47M+ to boost its ca­pac­i­ty in south­ern Ire­land

Gilead is adding it­self to the list of big names build­ing out mul­ti­mil­lion-dol­lar ex­pan­sions in Ire­land.

The phar­ma is ex­pand­ing its fa­cil­i­ties lo­cat­ed in the town of Car­rigt­wohill, Ire­land, in Coun­ty Cork in the south of the coun­try. Gilead plans to sink €45 mil­lion ($47.5 mil­lion) in­to the ex­pan­sion which will be used to con­struct a 55,714-square-foot ware­house, ac­cord­ing to a state­ment emailed to End­points News. The in­vest­ment will re­sult in a small in­crease in its em­ploy­ee head­count in Cork, a Gilead spokesper­son said, but no oth­er de­tails were giv­en be­yond that.

The spokesper­son said:

Gilead’s op­er­a­tions in Ire­land are a crit­i­cal part of its glob­al sup­ply chain. This de­vel­op­ment will fa­cil­i­tate ad­di­tion­al fu­ture in­vest­ment in the com­pa­ny’s man­u­fac­tur­ing and pack­ag­ing ca­pa­bil­i­ties in the coun­try, as the site looks to sup­port an ex­pand­ed Gilead prod­uct port­fo­lio in the years ahead.

As re­port­ed by The Irish Times, Gilead aims to start con­struc­tion in April and ex­pects to be fin­ished by No­vem­ber of next year. The ware­house will pro­vide stor­age for both fin­ished prod­ucts and raw ma­te­ri­als.

The 366,000-square-foot man­u­fac­tur­ing site in Cork is re­spon­si­ble for 30% of all of Gilead’s sol­id oral drug de­vel­op­ment, with 24 of its prod­ucts be­ing pro­duced or pack­aged at Car­rigt­wohill. The site, ac­cord­ing to Gilead’s web­site, is al­so re­spon­si­ble for pro­duc­tion, qual­i­ty con­trol and pack­ag­ing for the dis­tri­b­u­tion of its prod­ucts to the EU and oth­er spots in­ter­na­tion­al­ly.

Gilead is al­ready in good com­pa­ny in Car­rigt­wohill, as sev­er­al ma­jor phar­mas have man­u­fac­tur­ing sites in the town and al­so have plans to ex­pand.

The Ger­man drug man­u­fac­tur­er Mer­ck KGaA is in­vest­ing ap­prox­i­mate­ly €290 mil­lion ($306.1 mil­lion) to in­crease its mem­brane man­u­fac­tur­ing ca­pac­i­ty in Car­rigt­wohill and sup­port its gene ther­a­py man­u­fac­tur­ing ca­pa­bil­i­ties. The lat­est plan comes on top of a €36 mil­lion ($38 mil­lion) in­vest­ment in 2021 for an­oth­er pro­duc­tion line at its fa­cil­i­ty.

Ab­b­Vie is al­so in­ject­ing €60 mil­lion ($63.3 mil­lion) in­to its man­u­fac­tur­ing site in Car­rigt­wohill and plans to boost its head­count by 70, but oth­er de­tails were not avail­able.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

UK gov­ern­ment, pri­vate in­vestors dole out $340M+ to drug, di­ag­nos­tic man­u­fac­tur­ers

The government of the United Kingdom is giving out grants to several manufacturers that have a presence in England, Wales and Northern Ireland.

The government announced that four companies, including Ipsen, contract manufacturer Pharmaron, DNA manufacturer Touchlight and diagnostic test producer Randox, will receive a total of £277 million ($341.1 million). According to a release from the UK government, this represents the first portion of grants from the Life Sciences Innovative Manufacturing Fund.