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

The Covid-19 vac­cine IP waiv­er is back at the WTO, with a new dead­line. Can it muster enough sup­port?

World Trade Or­ga­ni­za­tion di­rec­tor-gen­er­al Ngozi Okon­jo-Iweala called on mem­bers late last week to move swift­ly and forge at least a draft agree­ment on the di­vi­sive IP waiv­er for Covid-19 vac­cines by the end of Feb­ru­ary.

Those ad­vo­cat­ing for such a waiv­er, in­clud­ing coun­tries like the US, In­dia and South Africa and oth­er aid groups like Doc­tors With­out Bor­ders, have called to help more coun­tries man­u­fac­ture their own vac­cines more quick­ly, a task that has lost sig­nif­i­cant time due to these long ne­go­ti­a­tions. Some like MSF ar­gue that the waiv­er shouldn’t just in­clude vac­cines but should pro­vide a “crit­i­cal le­gal path­way for coun­tries to fa­cil­i­tate more di­ver­si­fied and sus­tain­able pro­duc­tion and sup­ply” of all Covid-re­lat­ed tools, in­clud­ing tests and ther­a­peu­tics too.

Even Eu­ro­pean lead­ers, who at first balked at the idea, seemed to have come around in re­cent months.

On the oth­er side of the de­bate, the vac­cine de­vel­op­ers that de­vel­oped the cur­rent suite of prod­ucts (of­ten with sig­nif­i­cant gov­ern­ment sup­port) ar­gue that the IP waiv­er is not what’s con­strain­ing pro­duc­tion. Pfiz­er and BioN­Tech say they ex­pect to pro­duce 4 bil­lion dos­es of their vac­cine in 2022, and the IF­P­MA has said that man­u­fac­tur­ers in the US, EU, In­dia and Chi­na will like­ly make more than 12 bil­lion dos­es by mid-2022.

“We don’t want to cre­ate a sit­u­a­tion where peo­ple com­pete for re­sources, where there are dif­fer­ent ver­sions of the prod­uct,” BioN­Tech CEO Uğur Şahin told End­points News in an in­ter­view in No­vem­ber. “We re­al­ly be­lieve the way to deal with that is to ask the ques­tion of how — how this can be pro­duced, and to be re­al­ly pa­tient. It took us 10 years to de­vel­op this; there are 50,000 steps, it’s not just the man­u­fac­tur­ing, but the an­a­lyt­i­cal as­says, dozens of which need to be val­i­dat­ed.”

Re­gard­less, WTO’s Okon­jo-Iweala is push­ing ahead with her plan, de­spite an al­ready-missed De­cem­ber dead­line on the waiv­er.

“We should strive to get this re­sult out by the end of Feb­ru­ary. It will be re­al­ly sad if this or­ga­ni­za­tion keeps talk­ing and de­bat­ing on this pan­dem­ic, and that by the time we come up with a re­sponse peo­ple will not think it rel­e­vant. I think we should re­al­ly move with all speed to try and con­clude this by the end of Feb­ru­ary,” she said in a state­ment.

On Feb. 11, the WTO will hold a tech­ni­cal work­shop to sup­port these on­go­ing dis­cus­sions around Covid-19 vac­cine R&D, man­u­fac­tur­ing and dis­tri­b­u­tion, with rep­re­sen­ta­tives from As­traZeneca and No­vavax speak­ing.

“I have heard that there could be some sort of deal by then. No de­tails yet But I know that the EU, In­dia, South Africa, and the Unit­ed States have been meet­ing at the min­is­te­r­i­al lev­el on this,” Thiru Bal­a­sub­ra­ma­ni­am, the Gene­va rep­re­sen­ta­tive of the NGO Knowl­edge Ecol­o­gy In­ter­na­tion­al, told End­points.

Re­gard­ing these small-group dis­cus­sions on the IP-re­lat­ed as­pects of the pan­dem­ic re­sponse, Okon­jo-Iweala asked for WTO mem­bers’ pa­tience.

“This is a very dif­fi­cult is­sue. If it were easy, it would have been re­solved in the al­most two years that this dis­cus­sion has been go­ing on (in the TRIPS Coun­cil). This small group process … is go­ing on but it is very tough. I have to say there is no easy road,” she added.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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