Covid-19 roundup: Mer­ck shares mol­nupi­ravir with a UN-backed non­prof­it; GSK halts Covid-19 re­search on mon­o­clon­al an­ti­body

Mer­ck has agreed to li­cense mol­nupi­ravir to UN-backed non­prof­it Med­i­cines Patent Pool.

The non­prof­it will be work­ing with mul­ti­ple drug­mak­ers to pro­duce mol­nupi­ravir for 105 na­tions, in­clud­ing Pak­istan, Cam­bo­dia and all of Africa, the com­pa­ny and non­prof­it said Wednes­day.

Al­though MPP said it’s still un­clear how many pills will be pro­duced un­der the li­cens­ing deal —once man­u­fac­tur­ers’ plants are ful­ly op­er­a­tional, the non­prof­it pre­dict­ed that some man­u­fac­tur­ers will be able to start de­liv­er­ies this year.

Mer­ck, which de­vel­oped the drug along­side Ridge­back Bio­ther­a­peu­tics, said it can man­u­fac­ture 10 mil­lion cours­es of the an­tivi­ral by year’s end — amid in­creas­ing ca­pa­bil­i­ties to make more next year.

This is not the on­ly li­cens­ing deal Mer­ck had made re­gard­ing its drug — the big phar­ma pre­vi­ous­ly li­censed pro­duc­tion of mol­nupi­ravir to gener­ic drug­mak­ers in In­dia, in­clud­ing Dr. Red­dy’s Lab­o­ra­to­ries and Sun Phar­ma­ceu­ti­cal In­dus­tries.

Hu­man­i­tar­i­an aid group Doc­tors With­out Bor­ders bashed the deal, say­ing it’s too lim­it­ed in its reach — and could sti­fle sup­ply.

“Médecins Sans Fron­tières/Doc­tors With­out Bor­ders (MSF) ex­pressed dis­ap­point­ment with the lim­i­ta­tions of this li­cense, as its ter­ri­to­ry ex­cludes near­ly half of the world pop­u­la­tion and im­por­tant up­per-mid­dle-in­come coun­tries with ro­bust man­u­fac­tur­ing ca­pac­i­ty, such as Brazil and Chi­na, and con­tains a harm­ful pro­vi­sion un­der­min­ing the right of gener­ic com­pa­nies who sign the li­cense to chal­lenge patents to fa­cil­i­tate gener­ic-drug pro­duc­tion,” the non­prof­it said in a state­ment.

They end­ed their com­ments with a call to Mer­ck to grant glob­al li­cens­ing of the drug with­out ter­ri­to­ry re­stric­tions, and for the re­searchers who in­vent­ed the drug at Emory Uni­ver­si­ty to with­draw all glob­al patent claims.

GSK cuts re­search for Covid-19 hope­ful otil­imab

GSK has cut re­search on their mon­o­clon­al an­ti­body for Covid-19.

Un­veiled in GSK’s Q3 earn­ings re­port re­leased this morn­ing, GSK’s an­ti-GM-CSF mon­o­clon­al an­ti­body Otil­imab will no longer be ex­plored as a po­ten­tial treat­ment for se­vere pul­monary COVID-19 re­lat­ed dis­ease in pa­tients who are at least 70 years old. In­stead, the an­ti­body will be re­searched for rheuma­toid arthri­tis.

Ap­par­ent­ly, the phar­ma made the de­ci­sion be­cause their al­ready-ap­proved mon­o­clon­al an­ti­body Xe­vudy, in their words, “plays an im­por­tant role as a treat­ment for mild-to-mod­er­ate COVID-19 in high-risk adult and pe­di­atric pa­tients,” ac­cord­ing to a com­pa­ny state­ment.

The Phase III con­tRAst tri­al in­ves­ti­gat­ing otil­imab for rheuma­toid arthri­tis con­tin­ues as planned with piv­otal da­ta an­tic­i­pat­ed in the sec­ond half of next year.

EMA to host pub­lic stake­hold­ers call in late No­vem­ber

The EMA is host­ing an­oth­er pub­lic meet­ing vir­tu­al­ly on Nov. 25th about Covid-19 vac­cines and ther­a­peu­tics in the EU.

Ac­cord­ing to the web­site, the call will cov­er vac­cines and ther­a­peu­tics, vac­cine safe­ty and vac­ci­na­tion rates in the EU, along with mis­in­for­ma­tion on vac­cines.

The event will al­so al­low the pub­lic and stake­hold­ers to fur­ther in­form EMA of any ex­pec­ta­tions and con­cerns.

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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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.

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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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