Man­u­fac­tur­ing roundup: mR­NA man­u­fac­tur­er nets $300M+ in­vest­ment to scale re­search; Cy­ti­va ac­quires Michi­gan fa­cil­i­ty

As mR­NA tech has been made more pop­u­lar by the Covid-19 pan­dem­ic, in­vestor cash is mak­ing its way to man­u­fac­tur­ers and re­searchers.

In their lat­est move, Irish biotech Nor­max Bio­med has net­ted a €300 Mil­lion, or $305 mil­lion, in­vest­ment from pri­vate firm GEM Glob­al Yield.

The deal will see GEM pro­vide Nor­max with a share sub­scrip­tion fa­cil­i­ty of up to €50 Mil­lion for a 36-month term fol­low­ing the pub­lic list­ing of the Nor­max com­mon stock.

Nor­max will con­trol the tim­ing and max­i­mum amount of each draw­down un­der the fa­cil­i­ty and has no min­i­mum sub­scrip­tion oblig­a­tion. Nor­max is plan­ning to list it­self on ei­ther the  SIX Swiss Ex­change, SIX Dig­i­tal Ex­change (SDX), or the Lon­don Stock Ex­change as well.

Ac­cord­ing to Nor­max CEO Pe­ter Jensen, af­ter the cap­i­tal com­mit­ment, the com­pa­ny plans to al­so in­crease re­search and de­vel­op­ment of mR­NA vac­cines for Covid-19, TB, HIV and Malar­ia and de­ploy mod­u­lar mR­NA Vac­cine Fac­to­ries, in up 100 lo­ca­tions.

“In the event of an­oth­er pub­lic health emer­gency, we are al­so com­mit­ted to de­liv­er­ing fu­ture mR­NA vac­cines in 100 days, to help en­sure that Covid-19 is the last pan­dem­ic we will all suf­fer through. Dead­ly dis­eases wait for no man and no mar­ket,” Jensen said in a state­ment.

He al­so said that de­spite mar­ket con­di­tions not be­ing ide­al, Nor­max will go to mar­ket in 2022.

“Our Nor­max core busi­ness of mR­NA vac­cine R&D and man­u­fac­tur­ing can de­liv­er sus­tain­able re­turns on fun­da­men­tal health­care needs that bi­o­log­i­cal­ly will last for­ev­er. Pathogens are in­evitable, but dis­eases are not,” he said.

Ac­cord­ing to the com­pa­ny, it us­es mod­u­lar man­u­fac­tur­ing sites that can al­low the con­struc­tion of an mR­NA vac­cine fac­to­ry and the pro­duc­tion of mR­NA vac­cines wher­ev­er need­ed.

Cy­ti­va ac­quires a site in Michi­gan for resin man­u­fac­tur­ing

While Cy­ti­va has been plac­ing in­vest­ments in­ter­na­tion­al­ly, its lat­est move takes them to the wolver­ine state.

Ac­cord­ing to the com­pa­ny, it is in­vest­ing in more resins man­u­fac­tur­ing op­er­a­tions out­side of Swe­den for the first time in its his­to­ry.

The com­pa­ny has ac­quired a fa­cil­i­ty in Muskegon, Michi­gan. The new resins man­u­fac­tur­ing site is part of Cy­ti­va and Pall Cor­po­ra­tion’s $1.5 bil­lion ca­pac­i­ty ex­pan­sion in­vest­ment.

Cy­ti­va plans to trans­form the site in­to a 168,000-square-foot bio­man­u­fac­tur­ing cen­ter con­sist­ing of mul­ti­ple build­ings. Cy­ti­va is now ex­pand­ing be­yond Swe­den to man­u­fac­ture these resins. Resins are crit­i­cal in pu­ri­fy­ing and an­a­lyz­ing bio­mol­e­cules so phar­ma­ceu­ti­cal and life sci­ences com­pa­nies can make med­i­cines. The fa­cil­i­ty will al­so bring in an es­ti­mat­ed 200 em­ploy­ees when com­plet­ed, but the fi­nan­cial de­tails of the project were not dis­closed.

“When you’re look­ing to help pro­vide glob­al biotech­nol­o­gy so­lu­tions to the world, it re­quires you to be nim­ble and flex­i­ble. By in­vest­ing in Muskegon, Michi­gan, we will be clos­er to our North Amer­i­can cus­tomers, who are de­vel­op­ing ad­vanced bio­ther­a­peu­tics,” said Cy­ti­va CEO Em­manuel Lign­er in a state­ment.

The site re­ceived ben­e­fits from the Michi­gan Eco­nom­ic De­vel­op­ment Cor­po­ra­tion (MEDC) and the Michi­gan Strate­gic Fund (MSF). The site al­so has a co-op­er­a­tive agree­ment fund­ed through BAR­DA and has con­tract­ing sup­port from the DoD.

Con­struc­tion is planned to start at some point in Q3 2022, with man­u­fac­tur­ing ex­pect­ed to be­gin in 2026.

Drug man­u­fac­tur­er cen­tered on 3D print­ing nets deal with Eli Lil­ly

Chi­nese biotech Tri­astek and Eli Lil­ly have inked a deal to lever­age Tri­astek’s 3D print­ing tech­nol­o­gy to en­able tar­get­ed and pro­grammed re­lease of drugs in spe­cif­ic re­gions of the GI tract.

Ac­cord­ing to Tri­astek, the agree­ment will fo­cus on the re­lease of drugs in the in­tes­tine. Tri­astek will fo­cus on con­duct­ing an in-depth study of ex­cip­i­ent prop­er­ties and process pa­ra­me­ters to main­tain drug sta­bil­i­ty through­out the 3D print­ing man­u­fac­tur­ing process. The oth­er part of the deal will see Tri­astek iden­ti­fy­ing a dosage de­sign that will per­mit the pro­grammed re­lease of drugs in spe­cif­ic parts of the in­tes­tine, to im­prove the bioavail­abil­i­ty of oral­ly ad­min­is­tered drugs.

Tri­astek’s tech­nol­o­gy has ap­pli­ca­tions in both sol­id dosage form de­vel­op­ment and man­u­fac­tur­ing.

Lil­ly did not com­ment on the deal to End­points News.

“We en­vi­sion that the MED tech­nol­o­gy of Tri­astek can be used to solve the chal­lenges in for­mu­la­tions lead­ing to the de­vel­op­ment of clin­i­cal­ly valu­able prod­ucts for our glob­al part­ners,” said Tri­astek CEO Sen­ping Cheng.

WuXi makes sig­nif­i­cant man­u­fac­tur­ing in­vest­ments in Sin­ga­pore

WuXi AppTec and its sub­sidiary WuXi STA are stay­ing busy this week.

On Wednes­day, the par­ent com­pa­ny an­nounced a plan to build a new R&D and man­u­fac­tur­ing site in Sin­ga­pore.

The com­pa­ny in­tends to in­vest up to $1.43 bil­lion to con­struct and get the site ful­ly op­er­a­tional. The in­vest­ment is ex­pect­ed to be made in stages over the next 10 years, de­pend­ing on the com­pa­ny’s busi­ness needs.

The new site will be de­signed to ex­pand the com­pa­ny’s man­u­fac­tur­ing ca­pac­i­ty and en­hance its ca­pa­bil­i­ties but no there de­tails have been dis­closed.

“This in­vest­ment will fur­ther en­hance our ca­pac­i­ty and ca­pa­bil­i­ties so we can bet­ter sup­port our col­lab­o­ra­tive part­ners glob­al­ly and re­al­ize our shared vi­sion that every drug can be made, and every dis­ease can be treat­ed,” said WuXi CEO Ge Li in a state­ment.

Once com­plet­ed, the Sin­ga­pore site will al­so serve a role in its glob­al net­work across Asia, Eu­rope, and North Amer­i­ca.

De­ka Bio­sciences breaks ground on new fa­cil­i­ty

Mary­land-based biotech De­ka Bio­sciences has bro­ken ground on a 14,000-square-foot head­quar­ters to hold its man­u­fac­tur­ing, R&D and process de­vel­op­ment ca­pa­bil­i­ties.

The new build­ing will be in the Wash­ing­ton, DC sub­urb of Ger­man­town, MD. The com­pa­ny is ex­pect­ing to move in around the first quar­ter of next year.

The site will fur­ther de­vel­op its nov­el cy­tokine ther­a­pies.

“Our new fa­cil­i­ty will pro­vide us with es­sen­tial space to ex­pand our re­search, de­vel­op­ment and man­u­fac­tur­ing ef­forts, al­low­ing us to con­tin­ue to suc­cess­ful­ly de­vel­op our Di­akine ther­a­pies, us­ing sin­gle-use tech­nol­o­gy to scale both quick­ly and eco­nom­i­cal­ly,” said De­ka CEO John Mumm, in a state­ment.

Ac­cord­ing to the com­pa­ny, this is al­so the first fa­cil­i­ty to house a dual-tar­get­ed cy­tokine de­vel­op­ment lab in the Wash­ing­ton DC area.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Rahul Singhvi, Resilience CEO

Q&A: Re­silience boss Rahul Singhvi talks $2B US bio­man­u­fac­tur­ing ini­tia­tive and post Se­ries D deals

When the Biden administration announced last week, through an executive order, that it is investing $2 billion into domestic efforts to increase biotechnology and biomanufacturing efforts, a lot of ears perked up in the wider manufacturing world. Funding is going towards manufacturing infrastructure, training, R&D and security measures, among others, something that domestic manufacturers are bullish about.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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