Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Eu­rope re­serves 1.8 bil­lion dos­es of Pfiz­er vac­cines; Re­pub­li­cans slam Biden's TRIPS waiv­er sup­port

The Eu­ro­pean Com­mis­sion on Thurs­day signed a con­tract with Pfiz­er and BioN­Tech that will al­low for the pur­chase of 900 mil­lion dos­es of the cur­rent vac­cine and of a vac­cine adapt­ed to vari­ants, with the op­tion to pur­chase an ad­di­tion­al 900 mil­lion dos­es.

The EU cur­rent­ly has 600 mil­lion Pfiz­er dos­es through 2021, and the ad­di­tion­al 900 mil­lion are ex­pect­ed be­gin­ning in De­cem­ber 2021 and con­tin­u­ing in­to 2023.

In to­tal, the EU may have ac­cess to up to 2.4 bil­lion Pfiz­er dos­es, all of which are planned to be man­u­fac­tured in the EU.

Pfiz­er CEO Al­bert Bourla told Ax­ios in an in­ter­view yes­ter­day that the com­pa­ny feels “quite com­fort­able” that it’ll make 3 bil­lion dos­es of its vac­cine for the world by the end of 2021, and an­oth­er up to 4 bil­lion dos­es in 2022.

He said ap­prox­i­mate­ly 1 bil­lion dos­es will go to low- and mid­dle-in­come coun­tries this year, most of which will come in the sec­ond half of the year.

Longer re­frig­er­a­tor stor­age for Pfiz­er’s vac­cines

Fol­low­ing the Eu­ro­pean Med­i­cines Agency’s lead in al­low­ing for longer re­frig­er­a­tor stor­age (from five days to a month) of un­opened but thawed vials, the FDA did the same on Thurs­day.

Pfiz­er sub­mit­ted da­ta to the FDA to demon­strate that undi­lut­ed, thawed vials of its vac­cine are sta­ble at re­frig­er­a­tor tem­per­a­tures of 2°C to 8°C (35°F to 46°F) for up to 1 month, FDA added.

Re­pub­li­can sen­a­tors to Biden trade of­fi­cials: TRIPS waiv­er is ‘dis­as­trous de­ci­sion’

Re­pub­li­can sen­a­tors blast­ed US trade rep­re­sen­ta­tive Kather­ine Tai and Com­merce Sec­re­tary Gi­na Rai­mon­do, call­ing the Biden ad­min­is­tra­tion’s sup­port for tem­porar­i­ly halt­ing in­tel­lec­tu­al prop­er­ty pro­tec­tions for Covid-19 vac­cines a “dis­as­trous de­ci­sion.”

Sens. Tom Cot­ton (R-AR), Chuck Grass­ley (R-IA), Thom Tillis (R-NC), Mike Crapo (R-ID) and 10 oth­ers claimed the waiv­er would “force Amer­i­can com­pa­nies to give their med­ical tech­nol­o­gy and man­u­fac­tur­ing process­es to for­eign ad­ver­saries like Chi­na.”

They al­so rea­soned that there are not enough vac­cine dos­es at this time be­cause “the sup­ply chain lacks the tech­no­log­i­cal ca­pac­i­ty. Vac­cine pro­duc­tion is a com­plex tech­ni­cal and lo­gis­ti­cal process, with lim­it­ed tech­ni­cal re­sources (e.g., skilled sci­en­tists and tech­ni­cians at com­pa­nies). At best, all Pres­i­dent Biden’s give­away to Chi­na and In­dia and oth­ers will do is fos­ter un­co­or­di­nat­ed vac­cine na­tion­al­ism, as coun­tries jump in to try to co­erce tech­nol­o­gy trans­fer and man­u­fac­tur­ing lo­cal­ly.”

Pfiz­er and Mod­er­na have al­so both made clear in re­cent weeks that they are not go­ing to help any com­pa­nies try­ing to make copy­cat ver­sions of their prod­ucts, es­pe­cial­ly as they would be vy­ing for the same raw ma­te­ri­als and nec­es­sary equip­ment.

Tai, who’s re­spon­si­ble for ne­go­ti­at­ing the waiv­er at the WTO on be­half of the Biden ad­min­is­tra­tion, tes­ti­fied be­fore the Sen­ate Fi­nance Com­mit­tee last week. For coun­tries where less than 2% of their peo­ple are vac­ci­nat­ed, this is an ex­is­ten­tial cri­sis, Tai said, stress­ing the ur­gency and tem­po­rary na­ture of the de­ci­sion.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Paul Hudson, Sanofi CEO (Photographer: Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi, Re­gen­eron’s Dupix­ent scores an­oth­er in­di­ca­tion with first-ever ap­proval for nodu­lar skin dis­or­der

Sanofi chief executive Paul Hudson told investors earlier this year that the Big Pharma was going to emphasize its sales kingpin Dupixent moving forward.

He wasn’t joking — the megablockbuster drug and sales king, recording just shy of $2 billion in sales this past quarter, has now officially secured its fifth indication from the FDA.

Sanofi and Regeneron, who jointly work on Dupixent development and commercialization, announced the new development on Thursday, saying that the FDA gave the all-clear to Dupixent to treat patients with prurigo nodularis, a rare autoimmune disorder characterized by a persistent, severe itch — and also visualized by hard, extremely itchy bumps known as nodules that form on the skin. The FDA noted in its announcement that it is the agency’s first approval for the disease.

Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA (Sipa via AP Images))

Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

The US Senate passed via unanimous consent on Thursday afternoon a bipartisan bill that would eliminate a federal mandate for animal testing for new drugs.

Touted as a much-needed modernization of FDA’s rules, co-sponsor Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have said the bill will stop lots of needless suffering of animals.

Pa­tient re­port finds con­sti­pa­tion con­di­tion not well man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

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Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

The European Medicines Agency said Thursday that it’s launching a new pilot program to help academic and other nonprofit researchers developing advanced therapy medicinal products, which includes cell and gene therapies.

Academics have proven to be enormously useful in feeding new products, like chimeric antigen receptor (CAR)-T cell therapies first developed by Memorial Sloan Kettering, and ushered to the market by biopharma companies. Jean Bennett, formerly with the University of Pennsylvania, also saw her research lead to the approval of gene therapy Luxturna, which Roche now owns.