FDA con­cerns at con­trac­tor Catal­ent site spurred on short­ages of No­vo Nordisk's semaglu­tide — re­port

Just be­fore the start of the new year, No­vo Nordisk re­vealed its sup­ply of obe­si­ty med We­govy was low and that it would not be able to meet de­mand in the US un­til the sec­ond half of 2022.

Thanks to a Form 483 from the FDA, we now know that is­sues at Catal­ent’s flag­ship sy­ringe fill­ing site in Brus­sels, Bel­gium, was the rea­son for the de­lay, Bio­Process In­ter­na­tion­al re­port­ed.

The site is 265,000 square feet and has been hand­ed 12 483s in nine FDA vis­its, a source told Bio­Process, though it is be­lieved that this is the first that has halt­ed pro­duc­tion.

No­vo pre­vi­ous­ly an­nounced the short­age was due to man­u­fac­tur­ing is­sues at a con­tract man­u­fac­tur­er that was tasked with fill­ing sy­ringes for the pens. That news came just days af­ter No­vo an­nounced it would in­vest rough­ly $2.58 bil­lion to ex­pand its man­u­fac­tur­ing hub in Kalund­borg, Den­mark, with three new fa­cil­i­ties and the ex­pan­sion of a fourth to keep up with the suc­cess of its di­a­betes and obe­si­ty med semaglu­tide, mar­ket­ed in its in­jectable and oral for­mu­la­tions as We­govy and Ry­bel­sus, re­spec­tive­ly.

Sup­ply of the drug had al­ready sold out in June, soon af­ter the FDA is­sued its ap­proval. There is al­ready a one-month de­lay that led to No­vo apol­o­giz­ing to cus­tomers for its in­abil­i­ty to meet “un­prece­dent­ed de­mand.”

“We were mak­ing progress and had pro­ject­ed to sta­bi­lize sup­ply in ear­ly 2022,” the com­pa­ny said in a state­ment last month. “How­ev­er, we have been in­formed that our con­tract man­u­fac­tur­er re­spon­si­ble for fill­ing the We­govy pens for the US mar­ket has tem­porar­i­ly stopped de­liv­er­ies and man­u­fac­tur­ing fol­low­ing is­sues re­lat­ed to good man­u­fac­tur­ing prac­tices.”

No­vo has made a big bet on these drugs as the fu­ture of obe­si­ty treat­ment, pump­ing mon­ey in­to a new ad­ver­tis­ing cam­paign to frame it as a man­age­able health con­di­tion in­stead of a char­ac­ter flaw.

In the past, obe­si­ty drugs have strug­gled fol­low­ing FDA ap­proval, with No­vo’s Sax­en­da, land­ing on­ly 100,000 pa­tients pre­scribed the drug af­ter its 2015 launch and Vivus fil­ing for bank­rupt­cy less than 10 years af­ter its weight loss drug Qsymia failed to gen­er­ate even $9 mil­lion in sales in Q1 2020.

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

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.

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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.

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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.

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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.

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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.

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.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.