Covid-19 man­u­fac­tur­ing roundup: Kenya will add man­u­fac­tur­ing plant, up vac­ci­na­tion sites; South Ko­rea left wait­ing on Rus­sia vac­cine ex­ports

A fill-and-fin­ish man­u­fac­tur­ing site is pop­ping up in Kenya to help as­sure Covid-19 vac­cine sup­ply, the min­istry of health an­nounced Wednes­day.

The site will help third-par­ty drug­mak­ers put vac­cines in­to vials. As a re­sult, Kenya’s vac­ci­na­tion sites will more than triple — to 3,000 from 800 — lead­ing to the dou­bling of vac­cines in arms by De­cem­ber, Bloomberg re­port­ed.

Africa has been fo­cused on self-sus­tain­abil­i­ty on the Covid-19 vac­ci­na­tion front. In ear­ly Sep­tem­ber, BioN­Tech an­nounced it is con­sid­er­ing putting vac­cine man­u­fac­tur­ing sites in Rwan­da and Sene­gal to help beef up the con­ti­nent’s sup­ply.

That an­nounce­ment came af­ter it was learned that a South African plant that was giv­en $200 mil­lion from the US gov­ern­ment to pro­duce J&J’s shot was forced to send those jabs back to Eu­rope, de­spite an uptick in cas­es do­mes­ti­cal­ly.

With mil­lions of dos­es in stor­age, GL awaits Russ­ian man­u­fac­tur­ing ap­proval

A South Ko­re­an biotech is an­tic­i­pat­ing ap­proval from Rus­sia to ex­port the coun­try’s one-shot ver­sion of its Covid-19 vac­cine, Reuters re­port­ed Tues­day.

The Russ­ian Di­rect In­vest­ment Fund plans to pro­duce 700 mil­lion dos­es this year alone, and GL Rapha ex­pects to be the first man­u­fac­tur­er to gain ap­proval. Chair­man Whang Jae-gan said in an in­ter­view that every­thing on GL’s side is good to go, and the com­pa­ny just awaits val­i­da­tion of the process from Rus­sia. The com­pa­ny has 10 mil­lion dos­es of Sput­nik Light in stor­age, ready to be shipped in its Chun­cheon fa­cil­i­ty, east of Seoul, Reuters re­port­ed.

Sput­nik V and Sput­nik Light both await emer­gency use au­tho­riza­tion from the World Health Or­ga­ni­za­tion af­ter an Oc­to­ber 2020 sub­mis­sion.

In Au­gust, re­ports not­ed that Kaza­khstan might jump in­to the man­u­fac­tur­ing of Sput­nik Light in-coun­try, as it has lagged be­hind in its vac­ci­na­tion roll­out. Kaza­khstan al­ready has pro­duced the two-jab Sput­nik V, and re­ceived im­ports of the vac­cine from Rus­sia.

Sci­en­tists in Rus­sia re­port­ed 92% ef­fi­ca­cy in a Phase III tri­al of Sput­nik V, a num­ber that’s sur­passed ade­n­ovirus-based vac­cines, though ev­i­dence was scarce. Sput­nik V has been ap­proved by 70 coun­tries, in­clud­ing Hun­gary, Slo­va­kia and Syr­ia.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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