Prepar­ing for new wave of treat­ments, Fu­ji­film drops $55 mil­lion for gene ther­a­py cen­ter

The prepa­ra­tions to serve bio­phar­ma’s ex­plo­sion of gene ther­a­py pipeline can­di­dates con­tin­ues.

Sev­en months ago Ther­mo Fish­er put down $1.7 bil­lion for a ris­ing gene ther­a­py con­tract man­u­fac­tur­er. Catal­ent quick­ly fol­lowed up with a $1.2 bil­lion deal for gene ther­a­py play of its own, ac­quir­ing the Mary­land-based Paragon Bioser­vices.  And now, Fu­ji­film is ex­pand­ing its own ca­pa­bil­i­ties in the field — with the Japan­ese con­glom­er­ate in­vest­ing $120 mil­lion in­to the field and build­ing a “Gene Ther­a­py In­no­va­tion Cen­ter” be­side its re­cent­ly com­plet­ed base in Col­lege Sta­tion, Texas.

The new fa­cil­i­ty will cost $55 mil­lion, em­ploy 100 peo­ple and triple the com­pa­ny’s gene ther­a­py man­u­fac­tur­ing ca­pac­i­ty, Fu­ji­film said. The com­pa­ny did not say how the oth­er $65 mil­lion of its gene ther­a­py in­vest­ment would be spent.

“We are very much aware of the in­cred­i­ble growth in such an im­por­tant ther­a­peu­tic space,” said Mar­tin Mee­son, Pres­i­dent and COO of Fu­ji­film Diosynth Biotech­nolo­gies, US, in a state­ment.  “We know that we need to in­vest now, in tech­nol­o­gy, as­sets and peo­ple in or­der to achieve a mar­ket lead­er­ship po­si­tion.”

Mar­tin Mee­son

Al­though the gene ther­a­py mar­ket is still in its in­fan­cy, the com­pa­ny pro­ject­ed the CD­MO side would be worth $1.7 bil­lion by 2025. Ther­mo Fish­er said the gene ther­a­py man­u­fac­tur­er it ac­quired, Bram­mer Bio, was on pace to take in $250 mil­lion in 2019. And when Catal­ent an­nounced the Paragon deal, they said the com­pa­ny was on tar­get to bring in over $200 mil­lion this year.

The in­vest­ment pales to Fu­ji­film’s high-priced ac­qui­si­tions for cell ther­a­py, a larg­er space cur­rent­ly, and oth­er bi­o­log­ics. In Au­gust, the com­pa­ny pur­chased Bio­gen’s cell-cul­ture-de­rived-bi­o­log­ics fac­to­ry in Den­mark for $890 mil­lion cash. Last year, they spent $800 mil­lion on two cell cul­ture me­dia com­pa­nies, Irvine Sci­en­tif­ic Sales Com­pa­ny and IS Japan, from a Japan­ese oil gi­ant.

The new cen­ter will be 60,000 square feet and op­er­a­tional by 2021, the com­pa­ny said.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.