NeuEx­cell strikes deal with Fu­ji­film for stroke gene ther­a­py; J&J ex­pands in Ire­land

In an ef­fort to ad­vance a gene ther­a­py to treat is­chemic cor­ti­cal stroke, Fu­ji­film Diosynth Biotech­nolo­gies and NeuEx­cell Ther­a­peu­tics have reached an agree­ment to pro­duce drug sub­stance in Col­lege Sta­tion, TX.

Ger­ry Far­rell

Fu­ji­film will do so un­der an ac­cel­er­at­ed time­line for NeuEx­cell’s first-in-hu­man clin­i­cal stud­ies of NXL-001.

Ger­ry Far­rell, the COO of Fu­ji­film, says that the deal shows the com­pa­ny is able to work with com­pa­nies of all sizes.

“We are proud and de­light­ed to have been se­lect­ed by NeuEx­cell as the man­u­fac­tur­ing part­ner for their NXL-001 can­di­date. It is an hon­or for FDB to play a role help­ing to bring a treat­ment to pa­tients around the world who suf­fer from is­chemic cor­ti­cal stroke,” he said in a state­ment.”

NeuEx­cell is based out of Penn­syl­va­nia and is fo­cused on neu­rode­gen­er­a­tive dis­eases and the cen­tral ner­vous sys­tem. Its pipeline has in­ves­ti­ga­tion­al ther­a­pies for stroke, Hunt­ing­ton’s dis­ease, ALS, Alzheimer’s and Parkin­son’s dis­ease.

Fu­ji­film has es­tab­lished it­self as a key play­er in the gene ther­a­py pro­duc­tion plan, as it doled out $850 mil­lion in Ju­ly in­to US and UK lo­ca­tions to in­crease ca­pac­i­ty. Those ex­pan­sions will start in 2023, and brought the to­tal amount of mon­ey in­vest­ed in its CD­MO wing to $5.5 bil­lion in the past 10 years, in­clud­ing a $76 mil­lion in­crease in­to its Wa­ter­town, MA site that in­cludes eight clean­rooms and 40,000 square feet to be opened in 2022. It al­so opened a $2 bil­lion plant in Hol­ly Springs, NC, set to be op­er­a­tional by 2025.

J&J ex­pands in Ire­land

About 180 new jobs are com­ing to Cork, Ire­land, as J&J has an­nounced the ex­pan­sion of its man­u­fac­tur­ing site that’s been in op­er­a­tion since 2005.

The com­pa­ny has sub­mit­ted an ap­pli­ca­tion for a €150 mil­lion ex­pan­sion in Ringask­id­dy that will up the size by 8,202 square feet. The site is ded­i­cat­ed to man­u­fac­tur­ing prod­ucts that treat rheuma­toid arthri­tis, pso­ri­a­sis and can­cer, though it isn’t clear ex­act­ly which drugs are man­u­fac­tured there.

J&J fin­ished an ex­pan­sion at the site in 2019, adding more than 205,000 square feet of ca­pac­i­ty and an­oth­er 200 jobs.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Governor John Carney, Lieutenant Governor Bethany Hall-Long, Mayor Kenneth Branner, Jr., Delaware Prosperity Partnership President Kurt Foreman, WuXi AppTec Chairman and CEO Ge Li, WuXi AppTec Co-CEO and WuXi STA CEO Minzhang Chen, and others celebrate the groundbreaking for the WuXi STA Middletown campus.

WuXi breaks ground on Delaware fa­cil­i­ty, boost­ing its US pres­ence

While Middletown, Delaware’s main claim to fame was the site location for the film the Dead Poets Society, the city will soon play host to a massive manufacturing outfit.

WuXi AppTec’s contract research and manufacturing subsidiary WuXi STA, has broken ground on a 190-acre manufacturing campus in Middletown.

According to the company, this site will be WuXi’s second facility in the US, and it will create around 500 full-time jobs by 2026, but there are plans to kick off operations in 2025.