Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Que­bec-based Med­ica­go and its ad­ju­vant part­ner Glax­o­SmithK­line said Tues­day that their plant-based Covid-19 vac­cine can­di­date proved to be 71% ef­fi­ca­cious against all vari­ants of SARS-CoV-2 in a Phase III tri­al of more than 24,000 adults in Cana­da, the US, UK, Mex­i­co, Ar­genti­na and Brazil.

In ad­di­tion to show­ing 75% ef­fi­ca­cy against the Delta vari­ant specif­i­cal­ly, the com­pa­nies al­so said the vac­cine proved to be gen­er­al­ly safe, with no se­ri­ous ad­verse events re­port­ed and re­ac­to­genic­i­ty gen­er­al­ly be­ing mild to mod­er­ate. The re­sults mean that a reg­u­la­to­ry sub­mis­sion will be filed with Health Cana­da im­mi­nent­ly, they said.

Like its mR­NA coun­ter­parts, the Med­ica­go/GSK vac­cine is two dos­es, with each dose pro­vid­ed 21 days apart.

“These are en­cour­ag­ing re­sults giv­en da­ta were ob­tained in an en­vi­ron­ment with no an­ces­tral virus cir­cu­lat­ing. The glob­al COVID-19 pan­dem­ic is con­tin­u­ing to show new facets with the cur­rent dom­i­nance of the Delta vari­ant, up­com­ing Omi­cron, and oth­er vari­ants like­ly to fol­low,” Thomas Breuer, GSK’s glob­al Covid-19 ad­ju­vant­ed vac­cines lead, said in a state­ment. “The com­bi­na­tion of GSK’s es­tab­lished pan­dem­ic ad­ju­vant with Med­ica­go’s plant-based vac­cine tech­nol­o­gy has sig­nif­i­cant po­ten­tial to be an ef­fec­tive, re­frig­er­a­tor-sta­ble op­tion to help pro­tect peo­ple against SARS-CoV-2.”

GSK is al­so still work­ing with Sanofi and SK bio­science to de­vel­op ad­ju­vant­ed, pro­tein-based vac­cines, which are now in Phase III tri­als, as well as with Cure­Vac, to joint­ly de­vel­op a next-gen mR­NA vac­cine, with the po­ten­tial to ad­dress emerg­ing vari­ants in one vac­cine.

Pfiz­er CEO ex­pects an­tivi­ral to launch this month

In a race with Mer­ck to get an­tivi­rals to mar­ket, Pfiz­er CEO Al­bert Bourla told the Wall Street Jour­nal’s CEO Coun­cil on Tues­day that he ex­pects his com­pa­ny’s an­tivi­ral pill will hit the US mar­ket be­fore the end of this month.

Da­ta from Pfiz­er’s pill, known as Paxlovid, showed an 89% re­duc­tion in Covid-re­lat­ed hos­pi­tal­iza­tion or deaths in an in­ter­im analy­sis last month when com­pared to place­bo in pa­tients treat­ed with­in three days of symp­tom on­set. Pfiz­er al­so pre­vi­ous­ly said the US would pay $5.29 bil­lion for 10 mil­lion cours­es of the treat­ment.

Mer­ck, mean­while, nar­row­ly won the back­ing of an FDA ad­comm as pan­elists cen­tered their ques­tion­ing on the Mer­ck pill’s ef­fi­ca­cy and the cause of this drop off in pre­vent­ing hos­pi­tal­iza­tions and deaths, from 50% to 30% be­tween in­ter­im and fi­nal re­sults. Nei­ther Mer­ck nor the FDA could re­al­ly of­fer any spe­cif­ic caus­es for the de­cline.

The US has now pur­chased more than 3 mil­lion cours­es of Mer­ck’s an­tivi­ral, to be ac­quired from au­tho­riza­tion through ear­ly 2022, Mer­ck said. The con­tracts have earned Mer­ck a cool $2.2 bil­lion so far, and there are two mil­lion cours­es avail­able through fur­ther op­tions.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.