Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bay­er first set roots in Berke­ley back in 1974, when it was still op­er­at­ing as Miles Labs. The site has pumped out three he­mo­phil­ia A treat­ments for dis­tri­b­u­tion world­wide; but now, as the phar­ma con­tin­ues its cell and gene ther­a­py push, it has some­thing big­ger in mind.

Bay­er is plan­ning a 30-year re­vamp at the cam­pus, which in­cludes 918,000 square feet in new build­ings and dou­ble the jobs, ac­cord­ing to a re­port by the Bay Area Coun­cil Eco­nom­ic In­sti­tute.

By 2052, Bay­er ex­pects there to be about 2,000 jobs on site and an added 779,500 square feet of park­ing while de­mol­ish­ing around 267,000 square feet of ex­ist­ing space. All of that will run a price tag of about $1.2 bil­lion (ad­just­ed for in­fla­tion), ac­cord­ing to the coun­cil.

“While the COVID-19 pan­dem­ic and the fu­ture preva­lence of re­mote work chal­lenges the abil­i­ty to make pre­dic­tions, life sci­ences com­pa­nies like Bay­er will in­creas­ing­ly need more of­fice, de­vel­op­ment, lab­o­ra­to­ry, and man­u­fac­tur­ing spaces to op­er­ate ef­fi­cient­ly,” the re­port states.

A ma­jor­i­ty of the new con­struc­tion will be for pro­duc­tion, as well as the ma­jor­i­ty of new jobs, the coun­cil says. Oth­er new jobs will in­clude main­te­nance and lab­o­ra­to­ry work­ers, and ad­min­is­tra­tion.

“Bay­er, a glob­al bio­phar­ma­ceu­ti­cal com­pa­ny, is one of Berke­ley’s and the Bay Area’s ma­jor eco­nom­ic con­trib­u­tors,” the coun­cil states. “With a long-stand­ing pres­ence in Berke­ley through its bio­phar­ma­ceu­ti­cal cen­ter where it de­vel­ops and man­u­fac­tures med­i­cines for he­mo­phil­ia, Bay­er cre­ates em­ploy­ment op­por­tu­ni­ties at all in­come lev­els.”

In ad­di­tion to pro­duc­ing he­mo­phil­ia A treat­ments, the Berke­ley cam­pus al­so sup­ports the de­vel­op­ment of an in­ves­ti­ga­tion­al gene ther­a­py for the blood clot­ting dis­or­der.

Back in Oc­to­ber, Bay­er put down up to $4 bil­lion to buy out gene ther­a­py pi­o­neer Askle­pios, more com­mon­ly re­ferred to as AskBio. And in De­cem­ber, the com­pa­ny an­nounced it would es­tab­lish a cell and gene ther­a­py plat­form to con­sol­i­date all of its re­lat­ed projects un­der one um­brel­la, and al­low ex­ecs to swing some more deals.

“We need for all our plat­forms reach­ing out for oth­er part­ners look­ing for spe­cif­ic ca­pa­bil­i­ties where we can aug­ment our [own] ca­pa­bil­i­ties,” head of the new strat­e­gy Wol­fram Car­ius told End­points News at the time. “One ex­am­ple, of course, is al­ways the cap­sid de­sign can be im­proved, and there are ap­proach­es with ar­ti­fi­cial in­tel­li­gence that can do that even bet­ter than to­day.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Contract researcher Charles River Laboratories has been on a roll recently to flesh out its manufacturing arm with a specific focus on its capabilities in gene therapy. Now, the firm is putting its name to a big check for a Maryland-based viral vector firm it thinks will add to its growing expertise in the field.

Charles River will dole out $292.5 million for gene therapy CDMO Vigene Biosciences with the possibility for an additional $57.5 million in performance-based payments, the companies said Monday. The deal will close at the start of Q3, a Charles River spokesman said.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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