Can South Dako­ta's trans­genic cows help treat the flu?; A speedy re­view for Mer­ck­'s Pre­vnar ri­val in kids

Wednes­day brought an­oth­er win for South Dako­ta’s biggest trans­genic cow so far.

SAB Bio­ther­a­peu­tics, which de­vel­ops treat­ments by col­lect­ing and dis­till­ing an­ti­bod­ies from cows with hu­man­ized im­mune sys­tems, an­nounced that its an­ti­body treat­ment for flu passed an ear­ly-stage chal­lenge study.

Vol­un­teers were in­ten­tion­al­ly ex­posed to the flu virus and then giv­en in­fu­sions of the SAB an­ti­body treat­ment or place­bo. Those who re­ceived the an­ti­body treat­ment saw a sig­nif­i­cant­ly greater re­duc­tion in vi­ral load and symp­toms than those who re­ceived place­bo. The com­pa­ny didn’t re­lease num­bers but said the p-val­ue was 0.026.

SAB will move the an­ti­body in­to a Phase II study next year. A hand­ful of oth­er com­pa­nies are al­so work­ing on an­ti-flu an­ti­bod­ies, most no­tably Vir, which has two as­sets in Phase II, al­though both have been de­layed by the pan­dem­ic and the glob­al de­cline of flu in­fec­tions.

SAB dif­fers from Vir’s ap­proach in that it us­es poly­clon­al an­ti­bod­ies, or a col­lec­tion of an­ti­bod­ies, rather than mon­o­clon­al an­ti­bod­ies, i.e. a sin­gle an­ti­body. The idea is that poly­clon­al an­ti­bod­ies can be more ef­fec­tive by at­tack­ing the virus from dif­fer­ent an­gles, al­so mak­ing it hard­er for the virus to es­cape.

The com­pa­ny’s Covid-19 pro­gram showed pos­i­tive re­sults in Phase II.

A speedy re­view for Mer­ck’s Pre­vnar ri­val in chil­dren

Mer­ck has one ap­proval for its new pneu­mo­coc­cal vac­cine. It may soon be on its way to a sec­ond.

The NJ phar­ma an­nounced Wednes­day that the FDA gave the 15-va­lent vac­cine, known as Vaxneu­vance, pri­or­i­ty re­view for ap­proval in in­fants and chil­dren up to 17 years of age. The des­ig­na­tion sets up an FDA de­ci­sion by April 1, 2022.

The sub­mis­sion is based on da­ta from stud­ies show­ing that Vaxneu­vance works just as well at pro­tect­ing kids from 13 strains of bac­te­ria as Pfiz­er’s block­buster Pre­vnar-13. But, as in adults, in the re­al world, Mer­ck will have to com­pete with Pfiz­er’s next-gen­er­a­tion Pre­vnar-20.

Most ex­perts and an­a­lysts ex­pect Pre­vnar-20 will be­come the most com­mon­ly used vac­cine, be­cause it of­fers a wider breadth of pro­tec­tion than Vaxneu­vance.

MEI Phar­ma and Ky­owa Kirin of­fer first da­ta af­ter $100M cash pact

A year and a half ago, Ky­owa Kirin gave strug­gling mi­cro­cap MEI Phar­ma $100 mil­lion up­front and over $500 mil­lion to part­ner on what they saw as a promis­ing PI3K drug.

That deal de­liv­ered its first glimpse of div­i­dends Wednes­day, as the two com­pa­nies an­nounced in­ter­im re­sults from a Phase II study in lym­phoma. Just over 70% of the 91% of pa­tients who com­plet­ed the tri­al saw their tu­mors shrink by more than a third and 35.2% saw their tu­mors van­ish en­tire­ly.

The ef­fects were long-last­ing enough that, af­ter 8.4 months fol­low-up, not enough pa­tients had stopped re­spond­ing for in­ves­ti­ga­tors to de­ter­mine a me­di­an du­ra­tion of re­sponse.

The drug, known as zan­delis­ib, does come with safe­ty con­cerns, as many pre­vi­ous PI3K mol­e­cules have. Just un­der 10% of pa­tients in the tri­al stopped treat­ment be­cause of a drug-re­lat­ed side ef­fect.

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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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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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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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.

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.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.