Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

GSK inks $231M man­u­fac­tur­ing deal as Hal Bar­ron an­tic­i­pates fruit­ful year for pruned R&D group

Al­most halfway in­to the big turn­around year that Hal Bar­ron has blue­print­ed for Glax­o­SmithK­line’s R&D team, the Big Phar­ma is un­veil­ing a $231 mil­lion man­u­fac­tur­ing deal to match the grow­ing com­mer­cial port­fo­lio.

In a new part­ner­ship, GSK has en­list­ed Sam­sung Bi­o­log­ics to pro­vide ad­di­tion­al man­u­fac­tur­ing ca­pac­i­ty for its com­mer­cial spe­cial­ty care drugs, be­gin­ning with the lu­pus drug Benlysta. Pro­duc­tion will take place in Sam­sung’s fa­cil­i­ties in Ko­rea, the com­pa­ny told End­points News.

“This ca­pac­i­ty will be flex­i­ble de­pend­ing on GSK’s fu­ture needs and will sup­ple­ment GSK’s ex­ist­ing man­u­fac­tur­ing net­work,” the com­pa­ny wrote in a state­ment.

Em­ma Walm­s­ley GSK

Flex­i­bil­i­ty was sim­i­lar­ly the core theme in an $120 mil­lion up­grade an­nounced last Sep­tem­ber, when ex­ecs com­mit­ted to ex­pand­ing a long­time site in Up­per Meri­on, Penn­syl­va­nia.

The ma­jor­i­ty of Benlysta will still be man­u­fac­tured at Rockville, MD, one of nine US man­u­fac­tur­ing sites GSK cur­rent­ly op­er­ates and the lo­ca­tion for a new $150 mil­lion fa­cil­i­ty. Tech trans­fer to Sam­sung will start in 2020, with the first com­mer­cial sup­ply ex­pect­ed in 2022.

Ear­ly in Feb­ru­ary Bar­ron and CEO Em­ma Walm­s­ley out­lined plans for a “new GSK” in which the vac­cine unit would in­te­grate with the phar­ma group and non-core as­sets would be auc­tioned off, trig­ger­ing a round of lay­offs. Six po­ten­tial ap­provals are ex­pect­ed as Bar­ron’s 2-year cam­paign to re­verse the drug­mak­er’s lack­lus­ter de­vel­op­ment rep bears fruit.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,400+ biopharma pros reading Endpoints daily — and it's free.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,400+ biopharma pros reading Endpoints daily — and it's free.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,400+ biopharma pros reading Endpoints daily — and it's free.

VBL an­nounces pos­i­tive PhI­II da­ta for ovar­i­an can­cer drug; Gene­Cen­tric part­ners with Janssen on blad­der can­cer

VBL Therapeutics announced that it is on track in a Phase III trial of its drug VB-111 (ofranergene obadenovec) to treat platinum-resistant ovarian cancer in combination with paclitaxel.

After conducting its second interim analysis, the independent Data Safety Monitoring Committee (DSMC) recommended that Israel-based VBL continue full steam ahead. The committee looked at unblinded overall survival rate, which is the primary endpoint of the study, dubbed OVAL. The first analysis evaluated CA-125 response.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

UP­DAT­ED: Bris­tol My­ers Squibb com­mits $300 mil­lion to com­bat racial dis­par­i­ties, but de­clines to re­lease own de­mo­graph­ic da­ta

After the police killing of George Floyd, a flurry of pharma and biotech companies, executives and investors jumped out to make statements, either expressing support for Black Lives Matter and the protests or condemning systemic racism.

Now, a Big Pharma company is publicly putting some teeth behind those statements. This morning, Bristol Myers Squibb announced they would spend $300 million on a broad effort to reduce racial health disparities, and diversify both their clinical trials and their own executive team and workforce.

Martin Shkreli (AP Images)

Mar­tin Shkre­li's in­fa­mous Dara­prim falls off top 20 most ex­pen­sive drugs list

Martin Shkreli incited a national uproar five years ago when he raised the price of Daraprim by a factor of 56 essentially overnight from $13.50 to $750 per pill. Now that the “Pharma Bro’s” high-priced project has received a generic, it no longer places among the most expensive drugs in the world.

GoodRx is back with the latest update of the top 20 most expensive drugs and Daraprim’s exclusion marks the biggest change. The drug had previously ranked seventh on the list’s last iteration, which came in February before the world went into quarantine. Another of Shkreli’s former companies, Retrophin, saw its Chenodal drug place in the top 10 again.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,400+ biopharma pros reading Endpoints daily — and it's free.

FDA ac­cepts pri­or­i­ty re­view for Re­gen­eron's evinacum­ab, which could join Pralu­ent in cho­les­terol mar­ket

Almost a year ago to the day, Regeneron announced solid Phase III testing results for evinacumab, a compound that’s designed to lower LDL cholesterol in patients who need treatment beyond a PCSK9 inhibitor. As that anniversary approaches, the biotech is potentially one step closer to putting it on the market.

The FDA has granted priority review and accepted a BLA for evinacumab as a supplement to other lipid-lowering therapies in individuals with homozygous familial hypercholesterolemia, Regeneron announced Wednesday morning. Regeneron’s target action date is next February 11.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.