David Ricks, Eli Lilly CEO, steps away from the podium at the White House (Evan Vucci/AP Images)

UP­DAT­ED: US paus­es use of Eli Lil­ly's Covid-19 treat­ment na­tion­wide due to vari­ants

Due to the pres­ence of vari­ants, the US said Fri­day that it’s paus­ing ship­ments of Eli Lil­ly’s mon­o­clon­al an­ti­body com­bo for the treat­ment of Covid-19 on a na­tion­al ba­sis un­til fur­ther no­tice.

The pause, which could amount to the loss of about $375 mil­lion in sales ac­cord­ing to one biotech an­a­lyst, is an­oth­er blow to Lil­ly’s ef­forts to treat Covid-19 out­side of the hos­pi­tal, as the com­pa­ny pre­vi­ous­ly had its EUA for bam­lanivimab re­voked.

“The CDC iden­ti­fied that the com­bined fre­quen­cies of the SARS-CoV-2 P.1/Gam­ma vari­ant (first iden­ti­fied in Brazil) and the B.1.351/Be­ta vari­ant (first iden­ti­fied in South Africa) through­out the Unit­ed States now ex­ceed 11% and are trend­ing up­ward,” John Redd, CMO of the Of­fice of the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse, said in a let­ter ob­tained by End­points News.

“Re­sults from in vit­ro as­says that are used to as­sess the sus­cep­ti­bil­i­ty of vi­ral vari­ants to par­tic­u­lar mon­o­clon­al an­ti­bod­ies sug­gest that bam­lanivimab and ete­se­vimab ad­min­is­tered to­geth­er are not ac­tive against ei­ther the P.1 or B.1.351 vari­ants,” Redd wrote.

Pre­vi­ous­ly, dis­tri­b­u­tion of the com­bo of bam­lanivimab and ete­se­vimab was halt­ed in 9 states, in­clud­ing Ari­zona, Cal­i­for­nia, Flori­da, In­di­ana, Ore­gon, Illi­nois, Mass­a­chu­setts, Rhode Is­land and Wash­ing­ton, as the com­bined fre­quen­cy of the Covid-19 vari­ants first iden­ti­fied in Brazil and South Africa ex­ceed­ed 10% then.

Lil­ly said in an emailed state­ment, “Bam­lanivimab and ete­se­vimab ad­min­is­tered to­geth­er do not re­tain neu­tral­iza­tion ef­fects against the Gam­ma or Be­ta vari­ant. The U.S. Food and Drug Ad­min­is­tra­tion (FDA) rec­om­mends that health care providers in the U.S. use al­ter­na­tive au­tho­rized mon­o­clon­al an­ti­body ther­a­pies un­til fur­ther no­tice. As we have seen over the last sev­er­al months, preva­lence of vari­ants varies by state, re­gion and even coun­try and can change rapid­ly. Lil­ly con­tin­u­al­ly mon­i­tors the glob­al COVID-19 en­vi­ron­ment, as­sess­ing the neu­tral­iza­tion of our an­ti­body ther­a­pies against a wide ar­ray of ex­ist­ing and emerg­ing mu­ta­tions and vari­ants as well as the avail­able ther­a­pies.”

States will still have the op­tion of us­ing two mon­o­clon­al an­ti­bod­ies de­vel­oped by Re­gen­eron and Vir/GSK as the vari­ants do not evade ei­ther of those treat­ments as well as they did with the Lil­ly treat­ments.

Bern­stein biotech an­a­lyst Ron­ny Gal said in a note to in­vestors late last month that the mar­ket will now like­ly shift in Re­gen­eron’s fa­vor.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with com­ment from Lil­ly.

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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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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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Elcin Barker Ergun, Menarini Group CEO

Amid Roche and Sanofi's oral SERD set­backs, Menar­i­ni gets speedy re­view at FDA

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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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.

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.