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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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