BioNTech's Ugur Sahin and Özlem Türeci after receiving the Federal Cross of Merit, March 19, 2021 (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)

BioN­Tech makes a splash with $10B+ pro­jec­tion for 2021 Covid-19 vac­cine sales

BioN­Tech, Pfiz­er’s rel­a­tive­ly qui­et Ger­man biotech part­ner for its Covid-19 vac­cine, made noise on Tues­day with its earn­ings re­port, pro­ject­ing about €10 bil­lion ($11.5 bil­lion) in vac­cine rev­enue based on the cur­rent­ly signed sup­ply con­tracts for about 1.4 bil­lion dos­es.

The €10 bil­lion pro­jec­tion for the grow­ing com­pa­ny, found­ed by the hus­band and wife team of Ugur Sahin and Özlem Türe­ci, comes al­most ex­act­ly a year af­ter the com­pa­ny first an­nounced its plans to join up with Pfiz­er and bring its mR­NA-based vac­cine to fruition. That pro­jec­tion al­so dwarfs Pfiz­er’s orig­i­nal agree­ment to pay BioN­Tech $185 mil­lion up­front for the vac­cine col­lab­o­ra­tion, even with the po­ten­tial fu­ture mile­stone pay­ments of up to $563 mil­lion.

By com­par­i­son, Pfiz­er has pro­ject­ed about $15 bil­lion in Covid-19 vac­cine sales for this year, while Mod­er­na is prep­ping for about $18 bil­lion in 2021 vac­cine sales.

An in­creased de­mand in the Pfiz­er/BioN­Tech Covid-19 vac­cine al­so means BioN­Tech said it will in­crease man­u­fac­tur­ing ca­pac­i­ty from 2 bil­lion dos­es in 2021 to 2.5 bil­lion dos­es.

“The in­crease is dri­ven by the op­ti­miza­tion of pro­duc­tion process­es, the re­cent ini­ti­a­tion of pro­duc­tion at BioN­Tech’s Mar­burg, Ger­many fa­cil­i­ty, reg­u­la­to­ry ap­proval for six dose vials, and the ex­pan­sion of our man­u­fac­tur­ing and sup­pli­er net­work,” the com­pa­ny said. The first batch­es of vac­cines from the Mar­burg site are ex­pect­ed to be de­liv­ered in the sec­ond half of April.

The com­pa­ny al­so said it more than quadru­pled its an­nu­al rev­enue in 2020 when com­pared to 2019, not­ing rev­enues were es­ti­mat­ed to be €482.3 mil­lion ($566 mil­lion) last year, com­pared to €108.6 mil­lion ($127 mil­lion) for 2019.

The in­flux of new rev­enue means the com­pa­ny can ac­cel­er­ate its pipeline of can­cer drugs, not­ing that this year it ex­pects at least four da­ta up­dates from po­ten­tial can­cer drugs, with up to three pro­grams ex­pect­ed to move in­to ran­dom­ized Phase II tri­als and six pre­clin­i­cal pro­grams mov­ing in­to Phase I tri­als.

BioN­Tech’s stock has cat­a­pult­ed from $40 per share at the be­gin­ning of 2020 to more than $100 per share to­day, with about a 6% jump on Tues­day’s fi­nan­cial re­port. That leaves the com­pa­ny with a $23 bil­lion-plus mar­ket cap.

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

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.