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.

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.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

President Joe Biden (AP Photo/Susan Walsh)

Biden signs law re­quir­ing more de­clas­si­fi­ca­tions on Covid-19's ori­gins

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.