Salvatore Mascia, Continuus Pharmaceuticals CEO

MIT spin­out Con­tin­u­us calls up­on Skan­s­ka to build MA site with fed­er­al de­fense mon­ey

A spin­out from an MIT lab has land­ed a deal with a Swedish de­vel­op­ment group to build a $125 mil­lion man­u­fac­tur­ing fa­cil­i­ty in Woburn, MA, just 15 miles out­side Boston.

Skan­s­ka signed a con­tract with Con­tin­u­us Phar­ma­ceu­ti­cals to ren­o­vate and build an­oth­er 50,000 square foot site up to cur­rent Good Man­u­fac­tur­ing Prac­tices stan­dards that will pro­duce dry ac­tive phar­ma­ceu­ti­cal in­gre­di­ents and fin­ished drug prod­ucts in both ster­ile in­jectable and tablets forms.

Con­tin­u­us is de­vel­op­ing a new plat­form it calls In­te­grat­ed Con­tin­u­ous Man­u­fac­tur­ing. This en­ables end-to-end drug pro­duc­tion and us­es the syn­the­sis of APIs and the fi­nal dosage form as a sin­gle seam­less process. The com­pa­ny was found­ed in 2012 and has raised $7.7 mil­lion so far, $5 mil­lion of which came from a 2019 Se­ries B.

Three crit­i­cal care med­i­cines and an ad­di­tion­al key drug will be made there to start, though Skan­s­ka says it will have room for growth. Con­tin­u­us spe­cial­izes in small-mol­e­cule phar­ma­ceu­ti­cals, and as re­cent­ly as Ju­ly opened a new 3,000-square-foot lab that holds clean room space and high-po­ten­cy ca­pa­bil­i­ties. That came half a year af­ter the com­pa­ny an­nounced it land­ed a $69 mil­lion con­tract from the De­part­ment of De­fense to make med­i­cines to treat crit­i­cal­ly ill pa­tients, in­clud­ing those with Covid-19.

That was the sec­ond gov­ern­ment deal award­ed to Con­tin­u­us. The com­pa­ny pre­vi­ous­ly signed on with the FDA to help es­tab­lish a sci­ence-based ap­proach to cre­at­ing reg­u­la­to­ry guide­lines for con­tin­u­ous man­u­fac­tur­ing.

“Our new lab space, lo­cat­ed one mile from our cur­rent man­u­fac­tur­ing site and cor­po­rate head­quar­ters, will help Con­tin­u­us ad­vance our mis­sion for on-de­mand de­liv­ery of af­ford­able, high-qual­i­ty, vi­tal med­i­cines to pa­tients in need of ther­a­peu­tic so­lu­tions, and will al­so help fa­cil­i­tate col­lab­o­ra­tions with in­no­va­tor com­pa­nies that are de­vel­op­ing high-po­ten­cy drugs,” CEO Sal­va­tore Mas­cia said.

Skan­s­ka re­cent­ly was as­signed to de­vel­op As­traZeneca’s Cam­bridge, UK R&D op­er­a­tions in 2020, but was re­placed by Mace af­ter As­traZeneca said the lat­ter had more ex­per­tise in the sci­en­tif­ic fit-out and com­mis­sion­ing. That project was plagued by de­lays, thanks to de­sign and roof load­ing is­sues.

Most re­cent­ly, Skan­s­ka com­plet­ed the con­struc­tion of Vir­ginia Hos­pi­tal Cen­ter’s newest out­pa­tient pavil­ion in Ar­ling­ton. Con­struc­tion in Woburn be­gan in Oc­to­ber 2021 and is sched­uled to wrap up in Q2 of this year.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

FDA's do­mes­tic in­spec­tion hold will con­tin­ue un­til Feb­ru­ary

Amid a backlog of inspections, the FDA has announced that it will extend its pause of domestic inspections not considered mission-critical due to the outbreak of the Omicron variant.

While the agency will continue both foreign and domestic inspections deemed mission-critical, others will be paused through at least Feb. 4, and restart as soon as possible after that.

Previously planned foreign inspections will carry on as long as they’re in a country that has been cleared, and are within the CDC’s Level 1 or Level 2 Covid-19 travel recommendation — otherwise, they’ll be rescheduled. The FDA hopes to return to a regular cadence for foreign inspections in April.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.