As TRIPS coun­cil meets, the IP waiv­er for vac­cines is on life sup­port ahead of a De­cem­ber dead­line

The WTO’s TRIPS Coun­cil is meet­ing to­day and to­mor­row to dis­cuss a Covid-19 vac­cine IP waiv­er that re­mains di­vi­sive and un­like­ly to be adopt­ed thanks to Eu­ro­pean op­po­si­tion, but which pro­po­nents still think could un­lock more vac­cine dos­es for low and mid­dle-in­come coun­tries.

Fol­low­ing the meet­ings this week, it’s ex­pect­ed there will be a bet­ter sense if some kind of waiv­er can be agreed to by De­cem­ber, Tahir Amin, an IP lawyer and co-ex­ec­u­tive di­rec­tor of I-Mak, told End­points News.

But he said that the odds of meet­ing the De­cem­ber dead­line are “al­ready look­ing slim giv­en the block­ing coun­tries’ time wast­ing with re­dun­dant counter pro­pos­als that of­fer more of a failed IP trad­ing sys­tem and the US not putting its whole weight in­to ne­go­ti­a­tions and an ac­tu­al text.”

De­spite ini­tial sup­port from the Biden ad­min­is­tra­tion, the bio­phar­ma in­dus­try and Eu­ro­pean coun­tries — pre­dom­i­nant­ly the UK, Ger­many and Switzer­land — have re­mained firm­ly op­posed to the waiv­er. Pfiz­er went so far as to call it a “dis­trac­tion” and Mod­er­na CEO Stéphane Ban­cel said it wouldn’t help sup­ply any more mR­NA vac­cines over the next two years.

Even some promi­nent De­moc­rats are now rais­ing doubts about the waiv­er too.

Gary Locke, for­mer Com­merce Sec­re­tary and am­bas­sador to Chi­na un­der the Oba­ma ad­min­is­tra­tion, told End­points via email, “The pro­posed TRIPS waiv­er would do noth­ing to ex­pand mR­NA man­u­fac­tur­ing ca­pac­i­ty. Every sci­en­tist and com­pa­ny that knows how to make the vac­cines is al­ready work­ing to scale pro­duc­tion. And every fa­cil­i­ty on earth that can safe­ly and re­li­ably pro­duce shots is do­ing so.”

He al­so said he didn’t think the US should give away its tax­pay­er-fund­ed mR­NA re­search to coun­tries like Chi­na as that could “jeop­ar­dize Amer­i­can eco­nom­ic com­pet­i­tive­ness.”

But non­prof­its like Pub­lic Cit­i­zen have called on the US gov­ern­ment to start build­ing new sites and retro­fitting old­er ones to make more vac­cines.

“A $25 bil­lion in­vest­ment in vac­cine pro­duc­tion by the US gov­ern­ment would pro­duce enough vac­cine for low- and mid­dle-in­come coun­tries in one year,” the group says.

Locke agreed that wealthy na­tions “should fo­cus on do­nat­ing sur­plus Covid-19 vac­cine dos­es to de­vel­op­ing coun­tries, while al­so in­vest­ing in so­lu­tions to ac­tu­al­ly help dis­trib­ute those dos­es. For ex­am­ple, The De­mo­c­ra­t­ic Re­pub­lic of the Con­go re­turned 1.3 mil­lion dos­es to CO­V­AX, the glob­al vac­ci­na­tion-shar­ing ini­tia­tive, in part be­cause it couldn’t get the dos­es in­to rur­al ar­eas.”

Over the next two days, all eyes will be on the IP waiv­er, and whether it can ac­tu­al­ly ramp up vac­cine sup­plies.

“I’m hop­ing, al­beit not con­fi­dent, the US will ta­ble some lan­guage/text in sup­port of the In­dia/South Africa’s waiv­er — even if it does not to­tal­ly match the cur­rent re­vised waiv­er text. It will be need­ed to push the coun­tries block­ing to come with some­thing more in line with a broad­er IP waiv­er,” Amin said.

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.

A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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UP­DAT­ED: CMS to re­strict cov­er­age of Bio­gen's con­tro­ver­sial Alzheimer's drug to on­ly clin­i­cal tri­als

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.