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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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