Bay­er to dump $2.26B in­to man­u­fac­tur­ing re­align­ment as it says good­bye to some sites

Bay­er is ready to pour bil­lions more in­to its phar­ma man­u­fac­tur­ing op­er­a­tions, but with that, it will cut ties with sev­er­al sites it al­ready owns.

Bay­er will in­vest more than $2.26 bil­lion in its phar­ma­ceu­ti­cal man­u­fac­tur­ing over the next three years, as it ex­pands in both Eu­rope and the US. Ex­pan­sions in Bergka­men, Berlin, Lev­erkusen, Weimar and Wup­per­tal were al­ready an­nounced ear­li­er in March in a Ger­man-on­ly state­ment, stat­ing that it will mod­ern­ize fa­cil­i­ties and work on “more in­ten­sive col­lab­o­ra­tion” with area uni­ver­si­ties and star­tups.

The com­pa­ny will trans­form its sup­ply cen­ters in Berlin, Lev­erkusen and Bergka­men in­to cen­ters for ex­cel­lence for par­enter­als, non-hor­mon­al solids and con­trast me­dia and hor­mone prod­ucts, re­spec­tive­ly. A sup­ply cen­ter in Wup­per­tal will be turned in­to a site for new pro­duc­tion tech­nolo­gies. All these sites will see a com­bined in­vest­ment of rough­ly $1.1 bil­lion. Mean­while, its Berkley, CA, site will see an ex­pan­sion as well. It is al­ready build­ing a $200 mil­lion cell ther­a­py site in Berke­ley.

To do so, Bay­er has di­vest­ed a pro­duc­tion site in Karachi, Pak­istan, as a part of analy­sis of what man­u­fac­tur­ing prac­tices no longer align with long-term goals. Its site in São Paulo Can­cioneiro, Brazil will be trans­ferred to a new op­er­a­tor, and Bay­er plans to do the same with parts of the Bergka­men, Wup­per­tal and Berlin sites.

Bay­er has al­ready put up 95 acres of its Creve Coeur, MO, cam­pus up for sale, as it told the St. Louis Busi­ness Jour­nal that it en­vi­sions a fu­ture with less phys­i­cal of­fice space. In 2020, WuXi STA pre­pared to take over Bay­er fa­cil­i­ties in Lev­erkusen and Wup­per­tal to start and fin­ish the year.

“These in­vest­ments in­to our sup­ply net­work will sup­port the suc­cess of our com­pa­ny’s phar­ma­ceu­ti­cal’s busi­ness long term,” said Hol­ger Wein­tritt, head of phar­ma­ceu­ti­cals prod­uct sup­ply. “As an im­por­tant el­e­ment of our over­all phar­ma­ceu­ti­cal busi­ness strat­e­gy we will fo­cus our man­u­fac­tur­ing ac­tiv­i­ties on sup­port­ing fu­ture key ar­eas of growth in which we aim to change the treat­ment par­a­digm for pa­tients. All of our com­pa­ny’s new tech­nol­o­gy plat­forms and modal­i­ties will ben­e­fit from this in­vest­ment.”

All this comes months af­ter the an­nounce­ment that the Big Phar­ma would drop $460 mil­lion in­to two man­u­fac­tur­ing sites to ex­pand its pro­duc­tion ca­pa­bil­i­ties for con­tra­cep­tives to low- and mid­dle-in­come coun­tries. That deal fea­tured Bay­er ex­pand­ing one site in Turku, Fin­land, and build­ing an­oth­er in Ala­juela, Cos­ta Ri­ca, to pro­duce hor­mon­al im­plants and in­trauter­ine sys­tems. Bay­er has a goal of pro­vid­ing 100 mil­lion girls and women with ac­cess to fam­i­ly plan­ning by 2030. The new site in Cos­ta Ri­ca will start man­u­fac­tur­ing by 2024, the com­pa­ny said, while the Fin­land lo­ca­tion should be good to go by 2025.

Cell and gene ther­a­py will be the fo­cus for Bay­er’s lat­est an­nounce­ment. The bil­lions will go to­ward tech­nolo­gies, au­toma­tion, and dig­i­tal­iza­tion to help up­scale its man­u­fac­tur­ing.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.