Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP Images)

Pfiz­er shifts full port­fo­lio to non-prof­it mod­el in 45 low­er-in­come coun­tries

Pfiz­er is dou­bling down on its ef­forts to ad­dress health in­equities, shift­ing its full port­fo­lio to a not-for-prof­it mod­el in 45 low­er-in­come coun­tries.

The move builds on Pfiz­er’s “An Ac­cord for a Health­i­er World” ini­tia­tive launched back in May to in­crease ac­cess to the phar­ma gi­ant’s drugs and vac­cines. While the ini­tial pledge on­ly in­clud­ed 23 patent­ed prod­ucts avail­able in the US and EU, the lat­est com­mit­ment cov­ers all on- and off-patent brands, bring­ing the to­tal of­fer­ing to about 500 prod­ucts.

Any new launch­es will al­so be in­clud­ed in the ac­cord, Pfiz­er said in a news re­lease.

“Our hope is to em­pow­er coun­try gov­ern­ments and co-cre­ate so­lu­tions with them and oth­er mul­ti-sec­tor part­ners to break down many of the sys­tem-lev­el bar­ri­ers to bet­ter health,” CEO Al­bert Bourla said in the re­lease. “In the months since the Ac­cord’s launch, we have heard re­sound­ing­ly from these lead­ers that ac­cess to a broad­er and more im­me­di­ate scope of con­sis­tent, high-qual­i­ty prod­ucts is need­ed for mean­ing­ful and sus­tain­able trans­for­ma­tion.”

Rwan­da, Ghana, Malawi, Sene­gal and Ugan­da were the first five coun­tries to sign on to Pfiz­er’s ac­cord last year. The Bill & Melin­da Gates Foun­da­tion al­so chipped in, fund­ing Pfiz­er’s work on vac­cines for the pre­ven­tion of Group B strep­to­coc­cus, a lead­ing cause of still­birth and new­born mor­tal­i­ty in low-in­come coun­tries. In Sep­tem­ber, the group an­nounced ad­di­tion­al grants for both GBS and RSV, an­oth­er lead­ing cause of death for new­borns and young in­fants.

Last month, the FDA grant­ed Pfiz­er pri­or­i­ty re­view for its RSV vac­cine can­di­date RSVpreF, with an ex­pect­ed de­ci­sion date in May.

In Rwan­da specif­i­cal­ly, Pfiz­er de­liv­ered nine of its med­i­cines and vac­cines in 2022 to treat a range of can­cers, in­fec­tious and in­flam­ma­to­ry dis­eases, a spokesper­son said in an email to End­points News. The com­pa­ny al­so de­ployed a glob­al health team to the coun­try in No­vem­ber to “pro­vide tech­ni­cal as­sis­tance on sup­ply chain op­ti­miza­tion and to iden­ti­fy op­por­tu­ni­ties to strength­en the sys­tem in ar­eas such as ship­ping and sup­ply vis­i­bil­i­ty dash­boards.”

“The ex­pand­ed port­fo­lio of­fer­ing, com­bined with pub­lic health sys­tem strength­en­ing ef­forts, will fur­ther en­hance our progress and of­fer valu­able sup­port to key na­tion­al health ini­tia­tives that lead to pos­i­tive health out­comes,” Rwan­dan Pres­i­dent Paul Kagame said in the news re­lease.

Pfiz­er isn’t the on­ly phar­ma gi­ant mak­ing health eq­ui­ty com­mit­ments. Around the same time that Pfiz­er launched its ac­cord last year, the Union for In­ter­na­tion­al Can­cer Con­trol an­nounced that it had gath­ered a group of Big Phar­mas for a new coali­tion dubbed ATOM, or Ac­cess to On­col­o­gy Med­i­cines. As­traZeneca, BeiGene, No­var­tis, Bris­tol My­ers Squibb, Roche, Gilead, Sanofi and oth­ers joined the group. Sanofi sim­i­lar­ly made a pledge back in 2021 to make 30 of its “es­sen­tial” drugs, span­ning a range of con­di­tions from car­dio­vas­cu­lar dis­ease to can­cer, avail­able in low­er-in­come coun­tries, and last sum­mer re­leased more of the de­tails.

“As we learned in the glob­al COVID-19 vac­cine roll­out, med­i­cine sup­ply is on­ly the first step to help­ing pa­tients,” the Pfiz­er spokesper­son said. “The Ac­cord aims to bring gov­ern­ments and ex­perts to­geth­er – unit­ed to­wards a com­mon goal – to ad­dress the broad­er pub­lic health sys­tems bar­ri­ers that are lim­it­ing or pre­vent­ing ac­cess to in­no­v­a­tive med­i­cines and vac­cines, in­clud­ing ef­fec­tive di­ag­no­sis, ed­u­ca­tion, health in­fra­struc­ture, sup­ply chain in­tegri­ty and more.”

The news comes as the FDA and CDC in­ves­ti­gate a “pre­lim­i­nary sig­nal” of whether there may be an in­creased risk of stroke in some peo­ple who re­ceived Pfiz­er and BioN­Tech’s up­dat­ed Covid-19 boost­er shot. The CDC not­ed that the find­ings are high­ly pre­lim­i­nary, and that “no oth­er safe­ty sys­tems have shown a sim­i­lar sig­nal and mul­ti­ple sub­se­quent analy­ses have not val­i­dat­ed this sig­nal.”

Pfiz­er’s stock $PFE was down more than 3% on Tues­day morn­ing, trad­ing at around $46.29 per share.

This ar­ti­cle has been up­dat­ed to in­clude com­ment from Pfiz­er. 

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.