Ngozi Okonjo-Iweala, WTO Director-General (Salvatore Di Nolfi/Keystone via AP Images)

A wa­tered-down Covid-19 vac­cine IP waiv­er nears the fin­ish line: Will it ac­tu­al­ly ex­pand sup­plies?

The US, EU, In­dia, and South Africa have forged at least a pre­lim­i­nary agree­ment around an in­tel­lec­tu­al prop­er­ty (IP) waiv­er at the World Trade Or­ga­ni­za­tion — a move the four coun­tries hope will help oth­ers at­tain more Covid-19 vac­cine sup­plies, even as ad­vo­cates have said the waiv­er won’t do much.

The waiv­er, ac­cord­ing to a leaked draft ver­sion, will ap­ply to any de­vel­op­ing coun­try par­tic­i­pat­ing in the WTO that ex­port­ed less than 10% of the world’s Covid-19 vac­cine dos­es in 2021 (i.e., not Chi­na or Rus­sia, but In­dia could use it).

But it will be lim­it­ed to patents, and not in­clude oth­er trade se­crets, and it will on­ly cov­er vac­cines for now, and not ther­a­peu­tics or tests. But six months af­ter the vac­cine IP waiv­er takes ef­fect, the plan says that WTO mem­bers will de­cide on whether it should be ex­tend­ed to cov­er di­ag­nos­tics and ther­a­peu­tics too.

Those ad­vo­cat­ing for the waiv­er from the start did not of­fer much sup­port for this lat­est plan.

“This is not a vic­to­ry for vac­cine eq­ui­ty,” Tahir Amin, an IP lawyer and co-founder of the Ini­tia­tive for Med­i­cines, Ac­cess & Knowl­edge, tweet­ed, adding to End­points News:

So it ap­pears this ‘com­pro­mise’ in­cludes things the US were against as well as the EU. They have both squeezed the ne­go­ti­a­tion space of South Africa and In­dia to ac­cept a half baked so­lu­tion. I would em­pha­size this is not a TRIPS waiv­er in the full sense as hoped. It re­flects the pow­er dy­nam­ics that the Glob­al North coun­tries have and how the rules of the WTO are stacked against the Glob­al South in pan­demics and oth­er­wise.

“It does not do much that you can’t al­ready do,” KEI founder and IP waiv­er and com­pul­so­ry li­cense ad­vo­cate Jamie Love told End­points.

Non­prof­it ad­vo­ca­cy org Pub­lic Cit­i­zen al­so said in a state­ment that this pro­pos­al would help no one “but the floun­der­ing WTO and should be re­ject­ed.” The group not­ed key lim­i­ta­tions, in­clud­ing “the pro­pos­al ap­pears to cov­er on­ly vac­cines (not tests and treat­ments), cov­er on­ly patents (not oth­er im­por­tant in­tel­lec­tu­al prop­er­ty bar­ri­ers), be lim­it­ed ge­o­graph­i­cal­ly, and fur­ther un­der­mine cur­rent WTO flex­i­bil­i­ties for com­pul­so­ry li­cens­es.”

Bio­phar­ma in­dus­try groups were sim­i­lar­ly unim­pressed, with the IF­P­MA urg­ing the WTO that bio­phar­ma com­pa­nies “reaf­firm their po­si­tion that weak­en­ing patents now when it is wide­ly ac­knowl­edged that there are no longer sup­ply con­straints of COVID-19 vac­cines, sends the wrong sig­nal.”

Di­rec­tor-Gen­er­al Ngozi Okon­jo-Iweala al­so cau­tioned that not all of the fi­nal de­tails have been ironed out.

“In the WTO we de­cide by con­sen­sus, and this has not yet been achieved. My team and I have been work­ing hard for the past three months and we are ready to roll up our sleeves again to work to­geth­er with the TRIPS Coun­cil Chair Am­bas­sador Lansana Gberie (Sier­ra Leone) to bring about a full agree­ment as quick­ly as pos­si­ble,” she said in a state­ment.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

In­dus­try groups call to block WTO IP waiv­er ex­pan­sion to Covid-19 ther­a­peu­tics

The WTO’s TRIPS Council in mid-October is expected to debate whether to extend the IP waiver for Covid-19 vaccines to therapeutics and diagnostics too.

While the Biden administration backed the original vaccine waiver, which critics note has not done much to expand access to vaccines as demand has dried up, US trade officials haven’t offered any perspective yet on whether to expand the waiver to Covid treatments.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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