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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Bi­par­ti­san law­mak­ers pres­sure FDA on com­mon chemother­a­pies now in short­age

The US House of Representatives has turned a sharp eye to drug shortages over the past few months, with hearings and new caucuses to try and dampen the situation, but another bipartisan letter sent yesterday to FDA aims to keep the pressure up on cancer drug shortages.

Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI) penned the letter to FDA Commissioner Rob Califf, expressing concerns around the shortages of two commonly used chemotherapies used to treat cancer, known as cisplatin and carboplatin, which are used for lung, gynecologic and breast cancers, as well as methotrexate, which is used in treating other forms of cancer.

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Touchlight opens its new manufacturing facility in a newly-renovated Victorian-era building. (Credit: Touchlight)

DNA man­u­fac­tur­er Touch­light ex­pands its cam­pus to Vic­to­ri­an-era wa­ter­works build­ing

The manufacturing spaces for any type of DNA work may bring up images of a large, windowless, warehouse-type building, or a more modern facade donned with glass, but one manufacturer is converting an old Victorian-style building into a new manufacturing site.

Touchlight, a UK-based producer of a proprietary enzymatic DNA product it calls “doggybone DNA,” or dbDNA, which has a schematic structure that’s linear and double-stranded, giving the appearance of a dog bone, has opened the doors to a redeveloped and expanded manufacturing facility that is housed within a former Victorian-era waterworks building on the River Thames in the Borough of Hampton in West London. According to a release, the expanded facility has tripled Touchlight’s manufacturing output and can produce more than 8 kg of DNA product a year.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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