We­govy woes con­tin­ue as man­u­fac­tur­ing is­sues will lead to fur­ther short­age of Novo's obe­si­ty drug

As the new year rapid­ly ap­proach­es, and gyms and health food stores across Amer­i­ca pre­pare for a wave of peo­ple seek­ing weight loss, No­vo Nordisk has an­nounced that it does not ex­pect to meet de­mand for We­govy, its pre­scrip­tion in­jectable weight-loss med­ica­tion for obe­si­ty, un­til the sec­ond half of 2022 in the US.

The short­age comes due to man­u­fac­tur­ing is­sues at a con­tract man­u­fac­tur­er that was tasked with fill­ing sy­ringes for the pens. The news comes just days af­ter No­vo an­nounced that 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, We­govy and Ry­bel­sus.

“We were mak­ing progress and had pro­ject­ed to sta­bi­lize sup­ply in ear­ly 2022,” the com­pa­ny said in a state­ment. “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.”

This is not No­vo’s first time deal­ing with a short­age of the drug in its young life. Sup­ply sold out in June, soon af­ter the FDA is­sued an ap­proval for the drug and it launched. There’s al­ready a one-month de­lay that led to No­vo apol­o­giz­ing to cus­tomers for its in­abil­i­ty to meet with an “un­prece­dent­ed de­mand.”

No­vo al­so spon­sored a mar­ket­ing cam­paign fea­tur­ing ac­tress Queen Lat­i­fah at the helm to change the nar­ra­tive around obe­si­ty, look­ing to frame the di­ag­no­sis as a man­age­able health con­di­tion in­stead of a char­ac­ter flaw.

Over 40% of Amer­i­ca’s adult pop­u­la­tion, around 100 mil­lion peo­ple, are clas­si­fied as obese. Less than 10% of that pop­u­la­tion takes an an­ti-obe­si­ty med­ica­tion. We­govy is the same med­ica­tion as No­vo’s type 2 di­a­betes drug Ozem­pic, but at a high­er dose.

“We are do­ing our ut­most to over­come sup­ply con­straints, but un­for­tu­nate­ly this will take time to re­solve,” the com­pa­ny said.

The chal­lenges fac­ing sup­ply are not go­ing to im­pact the 2021 fi­nan­cial out­look that has al­ready been re­port­ed, No­vo said in a state­ment.

Obe­si­ty drugs have his­tor­i­cal­ly strug­gled fol­low­ing FDA ap­proval. No­vo’s Sax­en­da, launched in 2015, re­quires dai­ly in­jec­tions, and on­ly 100,000 pa­tients were pre­scribed the drug. Cur­rax’s Con­trave failed to gain trac­tion, though it is still in play long-term, and Vivus filed for bank­rupt­cy less than 10 years af­ter its weight loss drug Qsymia failed to gen­er­ate even $9 mil­lion in sales in Q1 2020.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,500+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,500+ biopharma pros reading Endpoints daily — and it's free.

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,500+ biopharma pros reading Endpoints daily — and it's free.

Man­u­fac­tur­ing woes con­tin­ue for Au­robindo af­ter FDA's warn­ing let­ter

An active pharmaceutical ingredient site in India has been handed a warning letter from the FDA, following an August 2021 inspection.

AuroLife Pharma’s Hyderabad site, which is part of the Aurobindo group of companies, was handed the letter in November. It’s the latest in a string of manufacturing woes the company has battled as of late.

Unit 1 of its Hyderabad site was inspected, and received an official action initiated notice from the FDA. “The company believes that this will not impact the existing business from this facility,” it said in a filing.

Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,500+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,500+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

Endpoints Premium

Premium subscription required

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