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.

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.

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.

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 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.