Jeff Baxter, VBI Vaccines CEO (ChromaDex)

VBI Vac­cines ex­ecs tout ap­proval of new triple-anti­gen he­pati­tis B shot. Can they sell it?

VBI Vac­cines cel­e­brat­ed a new ap­proval Wednes­day morn­ing, an­nounc­ing the FDA has green­light­ed its he­pati­tis B vac­cine for adults. But ques­tions re­main on how well the new shot will sell.

The biotech in­tends to hit the mar­ket in the first quar­ter of next year, join­ing three oth­er adult he­pati­tis B vac­cines from Mer­ck, Dy­navax and Glax­o­SmithK­line. CEO Jeff Bax­ter said in an an­a­lyst call Wednes­day the price of VBI’s shot, brand­ed as Pre­Hevbrio, won’t be re­vealed un­til com­mer­cial­iza­tion, but claimed it would be “high­ly com­pet­i­tive.”

In re­sponse to the news, VBI shares $VBIV trad­ed about 15% high­er in Wednes­day’s pre-mar­ket ses­sion. The price re­mains well with­in pen­ny stock ter­ri­to­ry, hit­ting about $3.45 per share.

Mer­ck and Dy­navax are the big names in this mar­ket, and Bax­ter faced ques­tions from in­vestors on Wednes­day’s call about how VBI in­tends to dif­fer­en­ti­ate it­self from those two shots. Bax­ter tout­ed VBI’s vac­cine as the first to con­tain three dif­fer­ent anti­gens against the he­pati­tis B virus and said that the “90 per­cent-plus” pro­tec­tion af­ter two dos­es gives VBI a po­ten­tial ad­van­tage.

One key re­main­ing piece is a full sign-off from the CDC’s ACIP, which vot­ed last month to broad­ly rec­om­mend uni­ver­sal he­pati­tis B vac­cines to all adults aged 19-59. Bax­ter not­ed the en­dorse­ment for VBI’s shot would need to hap­pen be­fore launch, but de­murred when asked if he want­ed to see ad­di­tion­al up­dates to the vac­cine rec­om­men­da­tions.

“At this stage I don’t think it goes be­yond that but just giv­en that rec­om­men­da­tion ob­vi­ous­ly … it is a very im­por­tant first step, and cre­ates a lev­el play­ing field for Pre­Hevbrio,” Bax­ter said on the call.

He added that the full go-ahead will help VBI get its shot cov­ered by both pub­lic and pri­vate and in­sur­ers, giv­ing it an­oth­er av­enue to cut in­to the Mer­ck and Dy­navax pie. But the biotech will al­so need to en­gage in aware­ness cam­paigns with physi­cians as well, for which Bax­ter said VBI is pre­pared.

Ap­proval of the new vac­cine came due to two Phase III stud­ies, pub­lished in sci­en­tif­ic jour­nals in May and Oc­to­ber of this year. VBI com­pared its vac­cine to GSK’s shot, which on­ly in­cludes one of the he­pati­tis B anti­gens. The first study showed high­er sero­pro­tec­tion in all adults, at 91.4% to 76.5%, as well as adults over 45 — 89.4% to 73.1%.

The sec­ond study, mean­while, aimed to show that VBI’s sero­pro­tec­tion re­mained con­sis­tent across three dif­fer­ent vac­cine lots. Af­ter two dos­es, Pre­Hevbrio man­aged a 90.4% sero­pro­tec­tion rate com­pared to 51.6% for the con­trol. The rates in­creased for both vac­cines af­ter third dos­es, hit­ting 99.3% and 94.8%, re­spec­tive­ly.

Out­side the US, the EMA is con­tin­u­ing its re­view of the shot, while VBI is plan­ning to file reg­u­la­to­ry sub­mis­sions to the UK and Cana­da ear­ly next year.

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.

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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.

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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.

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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.

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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.

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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.

UP­DAT­ED: FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

Steve Worland, eFFECTOR CEO

Sur­prise piv­ot rocks eF­FEC­TOR's I/O plans — al­though ex­ecs promise big­ger slice of the NSCLC mar­ket in the long run

When eFFECTOR Therapeutics went public last summer on the coattails of a reverse merger with Locust Walk’s SPAC, the potential of its lead drug, tomivosertib, as a combo agent with Merck’s flagship PD-1 Keytruda was hailed as the main draw.

But the biotech is now axing those plans and essentially starting over.

In a surprise move, San Diego-based eFFECTOR said it’s halting the development of tomivosertib in non-small cell lung cancer patients who have already progressed on Keytruda monotherapy after running into enrollment challenges in a Phase IIb trial.

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US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.