Covid-19 roundup: BAR­DA pumps $60M more in­to SAB treat­ment; EMA to de­cide on boost­ers next month

SAB Bio­ther­a­peu­tics said Thurs­day the US fed­er­al gov­ern­ment is pro­vid­ing it with an ad­di­tion­al $60.5 mil­lion, and more than $200 mil­lion in to­tal, to ad­vance its in­tra­venous poly­clon­al an­ti­body can­di­date for the treat­ment of Covid-19.

The treat­ment, known as SAB-185, is cur­rent­ly in a Phase II/III tri­al in non-hos­pi­tal­ized pa­tients with mild-mod­er­ate Covid-19 in­fec­tions at risk for dis­ease pro­gres­sion. It looks to be the third an­ti­body treat­ment for Covid-19 au­tho­rized in the US, fol­low­ing those from Re­gen­eron, Eli Lil­ly and GSK/Vir Biotech­nol­o­gy (which the fed­er­al gov­ern­ment is not dis­trib­ut­ing).

The Phase II por­tion of the tri­al re­cent­ly com­plet­ed full en­roll­ment, the com­pa­ny said, and it’s in­clud­ed in the AC­TIV-2 mas­ter pro­to­col, a study spon­sored, fund­ed and con­duct­ed by the NIH’s Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases. Lat­er this year, SAB is set to merge with Big Cy­press Ac­qui­si­tion Corp.

A short­age of mAb treat­ments due to the in­creased in­ci­dence of the Delta vari­ant has led HHS to re-work how it dis­trib­utes the mAb dos­es, and has sig­naled the need for more com­pa­nies to en­ter the space. For the weeks of Sept. 13 and 20, HHS re­port­ed dis­trib­ut­ing about 150,000 dos­es per week of the Re­gen­eron treat­ment to states and oth­er ter­ri­to­ries, and about 40,000 dos­es per week of Eli Lil­ly’s com­bo mAb, which re­cent­ly re-en­tered na­tion­wide dis­tri­b­u­tion.

EMA to de­cide on boost­ers in Oc­to­ber

The Eu­ro­pean Med­i­cines Agency will de­cide in ear­ly Oc­to­ber on the pos­si­ble use of a Pfiz­er/BioN­Tech boost­er dose, a source with di­rect knowl­edge of the mat­ter told Reuters.

The EMA said on Sept. 6 it be­gan eval­u­at­ing Pfiz­er’s boost­er dose ap­pli­ca­tion, which sought au­tho­riza­tion to ad­min­is­ter it six months af­ter the sec­ond dose in peo­ple aged 16 years and old­er.

The FDA au­tho­rized the Pfiz­er boost­er shots yes­ter­day for those who are 18 years and old­er at high risk of get­ting se­vere Covid-19, and for those who are old­er than 65.

Mod­er­na CEO says pan­dem­ic could end in a year

Mod­er­na head Stéphane Ban­cel told the Swiss news­pa­per Neue Zuercher Zeitung on Wednes­day that by the mid­dle of next year there will be enough vac­cines to dose every­one on Earth.

He al­so de­fend­ed the need for boost­er shots and his com­pa­ny’s de­ci­sion to on­ly use a half dose for its boost­er, not­ing that with the half-dose, 3 bil­lion dos­es of the Mod­er­na vac­cine will be avail­able world­wide for the com­ing year, in­stead of just 2 bil­lion.

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

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.

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ 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 129,700+ 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 129,700+ biopharma pros reading Endpoints daily — and it's free.

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 129,700+ biopharma pros reading Endpoints daily — and it's free.

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 129,700+ biopharma pros reading Endpoints daily — and it's free.

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.

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.