Hal Bar­ron’s GSK team con­tin­ues to cull res­pi­ra­to­ry drugs in big shift to on­col­o­gy R&D

The new R&D team un­der Hal Bar­ron is con­tin­u­ing to hack away at its res­pi­ra­to­ry pipeline.

Hal Bar­ron

The phar­ma gi­ant to­day sound­ed taps for six of its ex­per­i­men­tal drug pro­grams, leav­ing lit­tle doubt how its re­search pri­or­i­ties have shift­ed since Bar­ron was named R&D chief at the drug gi­ant.

In a foot­note to to­day’s quar­ter­ly up­date, which fo­cused con­sid­er­able at­ten­tion on on­col­o­gy af­ter the Tesaro buy­out and yes­ter­day’s bis­pe­cif­ic al­liance with Mer­ck­KGaA, GSK bid a fi­nal adieu to:

GSK1325756 (danir­ix­in) in COPD; GSK2269557 (ne­mi­ral­is­ib) in COPD; GSK2398852 + GSK2315698 (an­ti-SAP, for sys­temic amy­loi­do­sis) in AL/AT­TR-CM; GSK2245035 (TLR7 ag­o­nist) in asth­ma; GSK2798745 (TR­PV4 an­tag­o­nist) in ARDS and cough; GSK3008348 (aVb6 an­tag­o­nist) in id­io­path­ic pul­monary fi­bro­sis.

Three of these drugs were al­ready on the ter­mi­na­tion list af­ter Q3.

Bar­ron has been out­spo­ken about shift­ing the fo­cus in R&D to on­col­o­gy, where he is push­ing to make a come­back sev­er­al years af­ter the for­mer ex­ec­u­tive team at GSK swapped out its com­mer­cial on­col­o­gy port­fo­lio to No­var­tis in ex­change for a batch of vac­cines. GSK re­mains more than a lit­tle sen­si­tive on the top­ic, but the com­pa­ny has had lit­tle of the big suc­cess it needs in res­pi­ra­to­ry, es­pe­cial­ly now that Ad­vair fi­nal­ly faces the first in what will like­ly be a wave of gener­ic com­pe­ti­tion for its mega block­buster fran­chise.

Bar­ron, though, will have no trou­ble own­ing the pro­gram ex­e­cu­tions. Af­ter tak­ing over, the em­pha­sis at GSK has shift­ed to speed. If you fail, he says, it’s best to fail fast. And in this busi­ness, you can al­so ex­pect to fail of­ten.

“If I fail 70% of the time,” he told me re­cent­ly, “I’d be the most pro­duc­tive re­search per­son in his­to­ry.”

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.

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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.

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

Bris­tol My­ers Squibb com­mits $300 mil­lion to com­bat racial dis­par­i­ties and dou­ble num­ber of Black, Lati­no ex­ec­u­tives

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.

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.

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.”

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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.

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.

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Roche pulls a tu­mor mi­cro-en­vi­ron­ment drug out of the freez­er, hands it to a UK up­start

Two years after pulling it from clinical development, Roche has handed control of a solid tumor cancer drug to a tiny Oxford University spinout.

For an undisclosed fee, Celleron Therapeutics acquired the drug, an anti-CSF1R antibody that’s designed to modulate the tumor micro-environment — an increasingly popular approach among cancer drug developers. Celleron says it will now put the drug into trials for patients with tenosynovial giant cell tumors, a rare disease where series of benign tumors begin to grow around the joints and tendons. It’s caused by cells over-producing CSF1R.