Northway Biotech's new manufacturing facility in Greater Boston

North­way Biotech sets up shop in Boston hub, look­ing to court more cus­tomers with bi­o­log­ics-fo­cused plant

Get­ting a foot in the door in Boston’s bustling bio­phar­ma hub is a rite of pas­sage for many com­pa­nies, but it comes with a steep price tag. Lithuan­ian CD­MO North­way — now with a new moniker — will set up a new plant in close prox­im­i­ty, and it’s hop­ing its bi­o­log­ics fo­cus will find a will­ing cus­tomer base.

North­way Biotech (for­mer­ly North­way Biotech­phar­ma) on Wednes­day held a vir­tu­al grand open­ing cer­e­mo­ny for its $40 mil­lion Waltham, MA fa­cil­i­ty — a 30,000 square-foot cGMP man­u­fac­tur­ing and process de­vel­op­ment plant that will wide­ly ex­pand on the com­pa­ny’s pre­vi­ous ca­pa­bil­i­ties.

Cit­ing a de­sire to get its feet in­to the Boston-area hub, North­way set up its new plant to fo­cus on cell-line de­vel­op­ment, drug sub­stance man­u­fac­tur­ing, asep­tic fill­ing and end-to-end ser­vices for both mi­cro­bial and mam­malian bi­o­log­ics.

Ex­pect­ed to be ful­ly op­er­a­tional by the fi­nal quar­ter of 2021, North­way said in a press re­lease that the fa­cil­i­ty al­ready has ful­ly es­tab­lished labs for process, an­a­lyt­i­cal method de­vel­op­ment and qual­i­ty con­trol that have been sup­port­ing client projects for the past six months or so. Once ful­ly op­er­a­tional, the site will host 500-liter mi­cro­bial and 2,000-liter mam­malian biore­ac­tors.

It was an im­por­tant “strate­gic mile­stone” for the com­pa­ny, which has been in op­er­a­tion since 2004 in Lithua­nia and in Lon­don, North­way CEO Vladas Al­gir­das Bumelis said in a state­ment.

“We are very ex­cit­ed about this ex­pan­sion and are poised to sup­port our next-door part­ners in the Boston biotech hub, as well as oth­er do­mes­ti­cal­ly or in­ter­na­tion­al­ly lo­cat­ed com­pa­nies, by en­abling ac­cel­er­at­ed de­vel­op­ment and man­u­fac­tur­ing of their nov­el, life-sav­ing bio­phar­ma­ceu­ti­cals for clin­i­cal or com­mer­cial needs,” he said.

North­way’s Waltham site marks the lat­est biotech for­ay in­to Boston’s rapid­ly grow­ing biotech hub, which is burst­ing at the seams as it ex­pands in­to neigh­bor­ing cities. In ear­ly 2020, for ex­am­ple, End­points News re­port­ed that on­ly 0.8% of lab space was va­cant and still avail­able for rent in the area, while near­by East Cam­bridge (home to Kendall Square) was en­tire­ly oc­cu­pied — even with the high rent av­er­age of near $110 per square foot.

Just this week, Bio­Med Re­al­ty an­nounced a deal for near­ly 1.3 mil­lion square feet worth of space in Somerville, just five miles from Boston, and is seek­ing out ten­ants for what will be­come a ma­jor site in one of the world’s pre­mier biotech spaces.

Al­so of note re­cent­ly in the Boston area, Bris­tol My­ers Squibb in Au­gust inked a deal for a 360,000 square-foot lease at Cam­bridge Cross­ing, part of a 43-acre life sci­ences hub be­ing built on the city line be­tween Cam­bridge and Somerville.

As for North­way, the com­pa­ny has al­so wad­ed in­to the Covid-19 ther­a­peu­tics are­na of late. The com­pa­ny in Au­gust part­nered with Memo Ther­a­peu­tics, a Swiss biotech, to man­u­fac­ture Memo’s an­ti­body can­di­date over a four-month fast-track process. The drug can­di­date, gen­er­at­ed from con­va­les­cent Covid-19 donors, fo­cused on pi­co­mo­lar neu­tral­iz­ing ac­tiv­i­ty, the com­pa­nies said in an ini­tial press re­lease.

In De­cem­ber, soon af­ter the ini­tial fast-track process con­clud­ed, Memo an­nounced that the can­di­date was 100% ef­fec­tive in pre­vent­ing and treat­ing Covid-19 in ham­sters, and that the drug was head­ed to­ward a first-in-hu­man tri­al in the first quar­ter of this year.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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