President Joe Biden listens as Pfizer CEO Albert Bourla speaks (Patrick Semansky/AP Images)

Covid-19 roundup: Pfiz­er lands mas­sive $5B+ deal with US for po­ten­tial pill; Boost­ers for all adults are in­com­ing

Pfiz­er’s pill to treat Covid-19 is out­pac­ing its top ri­val from Mer­ck not on­ly in terms of ef­fi­ca­cy da­ta but now in the size of its US gov­ern­ment con­tract, too.

The US on Thurs­day an­nounced it will pay $5.29 bil­lion for 10 mil­lion cours­es of Pfiz­er’s po­ten­tial treat­ment, which is the largest sin­gle pro­cure­ment of any ther­a­peu­tic or vac­cine since the pan­dem­ic be­gan. And at $529 per course for the Pfiz­er pill, that’s sig­nif­i­cant­ly cheap­er than the $2.2 bil­lion the US paid for just 3 mil­lion cours­es of Mer­ck’s treat­ment, which adds up to about $730 per course.

Both com­pa­nies are still seek­ing EUAs to mar­ket their prod­ucts, al­though based on the size of these deals, those de­ci­sions from FDA may seem like an af­ter­thought.

Da­ta from a sched­uled in­ter­im analy­sis for Pfiz­er’s po­ten­tial drug showed an 89% re­duc­tion in risk of Covid-re­lat­ed hos­pi­tal­iza­tion or death from any cause com­pared to place­bo in pa­tients treat­ed with­in three days of symp­tom on­set. Pfiz­er said it halt­ed en­roll­ment in the tri­al be­cause of the pos­i­tive re­sults, and in con­sul­ta­tion with the FDA.

Mean­while, Pfiz­er said it will con­tin­ue to in­vest up to about $1 bil­lion to sup­port the man­u­fac­tur­ing and dis­tri­b­u­tion of its pill, in­clud­ing ex­plor­ing po­ten­tial con­tract man­u­fac­tur­ing op­tions. And Pfiz­er an­nounced a de­ci­sion ear­li­er this week to sign a vol­un­tary li­cens­ing agree­ment with the Med­i­cines Patent Pool to help ex­pand ac­cess.

US gov­ern­ment to in­vest bil­lions in mR­NA man­u­fac­tur­ing, with Pfiz­er and Mod­er­na’s help

Yes­ter­day’s press brief­ing from the White House COVID-19 Re­sponse Team un­veiled an in­ter­est­ing new nugget of in­fo on how this ad­min­is­tra­tion is plan­ning to ramp up vac­cine man­u­fac­tur­ing, al­though a lot of those plans will de­pend on the kind­ness of Pfiz­er and Mod­er­na.

White House coro­n­avirus re­sponse co­or­di­na­tor Jeff Zients told re­porters that HHS is so­lic­it­ing in­ter­est from com­pa­nies that have ex­pe­ri­ence man­u­fac­tur­ing mR­NA vac­cines to iden­ti­fy op­por­tu­ni­ties to scale up their pro­duc­tion ca­pac­i­ty.

“Im­por­tant­ly, ini­tial pro­duc­tion could pro­vide more mR­NA COVID vac­cines for the world. The goal of this pro­gram is to ex­pand ex­ist­ing ca­pac­i­ty by an ad­di­tion­al bil­lion dos­es per year, with pro­duc­tion start­ing by the sec­ond half of 2022,” Zients said.

The pro­gram is geared to pro­duc­ing dos­es with­in six to nine months of iden­ti­fy­ing a fu­ture pathogen and en­sur­ing enough vac­cines for all Amer­i­cans. BioN­Tech’s CEO told End­points in an in­ter­view last week that his com­pa­ny is try­ing to have a plan that would have a vac­cine shipped with­in three months of iden­ti­fy­ing a new vari­ant.

The plan cur­rent­ly is to “com­bine the ex­per­tise of the U.S. gov­ern­ment in ba­sic sci­en­tif­ic re­search with the ro­bust abil­i­ty of phar­ma­ceu­ti­cal com­pa­nies to man­u­fac­ture mR­NA vac­cines. We hope com­pa­nies step up and act quick­ly to take us up on this op­por­tu­ni­ty to ex­pand pro­duc­tion of mR­NA vac­cines for the cur­rent pan­dem­ic and set us up to re­act quick­ly to any fu­ture pan­dem­ic threats,” Zients said.

Com­ing soon: Mod­er­na and Pfiz­er boost­er shots for all adults

Mod­er­na and Pfiz­er have now both asked the FDA to sign off on their boost­er shots for all adults, which the agency could OK as ear­ly as this week, ac­cord­ing to the New York Times.

The CDC’s ad­vi­so­ry com­mit­tee is meet­ing to­mor­row for three hours in the af­ter­noon to dis­cuss the boost­er ef­fi­ca­cy and safe­ty da­ta, which some crit­ics have said is flim­sy, and en­tire­ly based on Is­raeli da­ta. But so far, 31 mil­lion Amer­i­cans have now re­ceived boost­ers too, ac­cord­ing to Zients.

And CDC Di­rec­tor Rochelle Walen­sky of­fered sup­port­ing da­ta on Wednes­day, telling re­porters:

In re­cent weeks, we have al­so seen ad­di­tion­al da­ta that re­in­force the im­por­tance of COVID-19 boost­ers for these pop­u­la­tions at high­er risk of se­vere dis­ease, par­tic­u­lar­ly to en­sure pro­tec­tion against se­vere ill­ness and hos­pi­tal­iza­tions…When we com­pare rates of COVID-19 dis­ease be­tween those who are vac­ci­nat­ed with two dos­es and those who have re­ceived a boost­er dose, the rate of dis­ease is marked­ly low­er for those who re­ceived their boost­er shot, demon­strat­ing our boost­ers are work­ing. FDA is cur­rent­ly eval­u­at­ing da­ta on the au­tho­riza­tion of boost­er dos­es for all peo­ple over age 18.  As we’ve done be­fore, CDC will quick­ly re­view the safe­ty and ef­fec­tive­ness da­ta and make rec­om­men­da­tions as soon as we hear from FDA.

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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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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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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.

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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