Ngozi Okonjo-Iweala (front right), World Trade Organization director-general, at the WTO's Ministerial Conference in Geneva, June 17, 2022 (Fabrice Coffrini/Pool Photo/Keystone via AP Images)

WTO's IP waiv­er for vac­cines is out and the re­sponse is gen­er­al­ly neg­a­tive — from all sides

The mem­ber coun­tries of the World Trade Or­ga­ni­za­tion ne­go­ti­at­ed late in­to last night, fi­nal­ly of­fer­ing up a com­pro­mised and wa­tered-down way for some low-in­come coun­tries to waive the in­tel­lec­tu­al prop­er­ty around cer­tain Covid-19 vac­cine in­gre­di­ents and man­u­fac­tur­ing process­es, po­ten­tial­ly paving the way for com­pul­so­ry li­cens­ing for these vac­cines.

While on­ly in ef­fect ini­tial­ly for five years, the waiv­er would hy­po­thet­i­cal­ly al­low low-in­come coun­tries to by­pass cer­tain Pfiz­er and Mod­er­na patents to pro­duce more Covid-19 vac­cines.

“The TRIPS waiv­er com­pro­mise will con­tribute to on­go­ing ef­forts to decon­cen­trate and di­ver­si­fy vac­cine man­u­fac­tur­ing ca­pac­i­ty, so that a cri­sis in one re­gion does not leave oth­ers cut off,” WTO di­rec­tor-gen­er­al Ngozi Okon­jo-Iweala said in a speech to­day.

But the de­ci­sion to al­low the waiv­er — af­ter more than a year of ne­go­ti­a­tions — comes at a time when coun­tries like Switzer­land and else­where are al­ready hav­ing to dump mil­lions of dos­es in the garbage be­cause they can’t do­nate them be­fore ex­pi­ra­tion. And it re­mains to be un­der­stood if any gov­ern­ments will ac­tu­al­ly seek to use this waiv­er in its cur­rent form.

Jamie Love, di­rec­tor of KEI who pub­lished an analy­sis on the waiv­er this morn­ing, told End­points News he’s “pret­ty con­fi­dent no one will” use the waiv­er right now, as it is “on­ly an ex­cep­tion for ex­ports un­der a com­pul­so­ry li­cense from de­vel­op­ing coun­tries mi­nus Chi­na. There are no vac­cines oth­er than Mod­er­na now us­ing com­pul­so­ry li­cens­es.”

And while the text of the agree­ment “was ac­tu­al­ly im­proved a fair amount this week,” Love said, “it’s still most­ly about prece­dent, and won’t have any ef­fect for years if at all.”

Oth­ers who were ad­vo­cat­ing for the IP waiv­er ini­tial­ly, and want­ed it to ex­tend to ther­a­peu­tics and oth­er Covid-re­lat­ed med­ical prod­ucts, and those who have been op­posed to it the en­tire way (PhRMA and oth­er in­dus­try groups), were not hap­py with the fi­nal re­sult.

“Rather than fo­cus on re­al is­sues af­fect­ing pub­lic health, like solv­ing sup­ply chain bot­tle­necks or re­duc­ing bor­der tar­iffs on med­i­cines, they ap­proved an in­tel­lec­tu­al prop­er­ty waiv­er on Covid-19 vac­cines that won’t help pro­tect peo­ple against the virus,” PhRMA said in a state­ment this morn­ing.

Doc­tors With­out Bor­ders/Médecins Sans Fron­tières sim­i­lar­ly took is­sue with the waiv­er, say­ing in a state­ment, “The waiv­er that was agreed to con­tains a po­ten­tial­ly harm­ful set of clar­i­fi­ca­tions of the ex­ist­ing pub­lic health safe­guards and a lim­it­ed ex­cep­tion for the pro­ce­dure of us­ing com­pul­so­ry li­cens­ing for ex­port of Covid-19 vac­cines by el­i­gi­ble coun­tries for a du­ra­tion of five years.”

US Cham­ber of Com­merce Glob­al In­no­va­tion Pol­i­cy Cen­ter SVP Patrick Kil­bride al­so added:

Mis­guid­ed pro­pos­als to un­der­mine in­tel­lec­tu­al prop­er­ty rights would set a harm­ful prece­dent with­out solv­ing any of the ac­tu­al prob­lems pre­vent­ing more wide­spread vac­ci­na­tion. Waiv­ing in­tel­lec­tu­al prop­er­ty rights would on­ly hob­ble the in­no­va­tion that is crit­i­cal to im­prov­ing lives and rais­ing liv­ing stan­dards glob­al­ly.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

The rise of pharma environmental, social and governance (ESG) efforts in the past two years has been meteoric as investors turn their attention to sustainable funding. However, investors aren’t the only ones watching. Patients are beginning to tune into pharmas’ ESG promises too.

Patient advocacy groups familiar with ESG regard it as an important issue and want to be included in helping pharma companies set ESG policies and targets, according to a new report from PatientView. That’s quite different from what the investment community wants across a variety of Gartner’s defined financial, competitive, strategic and perception goals.