Mer­ck CEO Ken Fra­zier re­signs from Trump coun­cil in protest, and the pres­i­dent swift­ly bites back

Mer­ck CEO Ken Fra­zier, the on­ly African-Amer­i­can run­ning a top glob­al bio­phar­ma com­pa­ny, has very pub­licly bro­ken with Pres­i­dent Trump, re­sign­ing in protest from the ad­min­is­tra­tion’s man­u­fac­tur­ing coun­cil in the wake of a grow­ing con­tro­ver­sy over the pres­i­dent’s un­will­ing­ness to sin­gle out white su­prema­cy groups in the vi­o­lent protests over the week­end in Char­lottesville, VA.

This move by Fra­zier will put con­sid­er­able pres­sure on the rest of the in­dus­try and its lob­by­ists to sep­a­rate them­selves from Trump — some­thing they’ve been loath to do – and take a more crit­i­cal po­si­tion on Trump’s pres­i­den­cy as well as some of his poli­cies.

It is al­so di­rect­ed against a pres­i­dent who has proven to be no­to­ri­ous­ly thin-skinned about crit­i­cism of any kind. And Trump proved that by fir­ing back right at Fra­zier one of the in­dus­try’s weak spots. He tweet­ed:

Fra­zier, though, was clear­ly fed up with the pres­i­dent to­day.

Tak­ing to Trump’s fa­vorite medi­um, Twit­ter, Mer­ck quot­ed Fra­zier, say­ing:

I am re­sign­ing from the Pres­i­dent’s Amer­i­can Man­u­fac­tur­ing Coun­cil.

Our coun­try’s strength stems from its di­ver­si­ty and the con­tri­bu­tions made by men and women of dif­fer­ent faiths, races, sex­u­al ori­en­ta­tions and po­lit­i­cal be­liefs.

Amer­i­ca’s lead­ers must hon­or our fun­da­men­tal val­ues by clear­ly re­ject­ing ex­pres­sions of ha­tred, big­otry and group su­prema­cy, which run counter to the Amer­i­can ide­al that all peo­ple are cre­at­ed equal.

As CEO of Mer­ck and as a mat­ter of per­son­al con­science, I feel a re­spon­si­bil­i­ty to take a stand against in­tol­er­ance and ex­trem­ism.

The con­tro­ver­sy over the pres­i­dent’s state­ment cit­ing “many sides” for the vi­o­lence in Char­lottesville — which in­clud­ed the death of one of the pro­test­ers who turned out to op­pose demon­stra­tions by neo-Nazis and oth­er right-wing ex­trem­ists — has been gain­ing vol­ume steadi­ly.

The move clear­ly didn’t hurt Mer­ck’s stock. The phar­ma gi­ant’s shares were up 1% in ear­ly trad­ing to­day.

Fra­zier’s de­ci­sion to stand down now comes as the bio­phar­ma in­dus­try has sought to lob­by the White House for new rules al­low­ing for the repa­tri­a­tion of bil­lions of dol­lars in over­seas ac­counts at a more at­trac­tive tax rate. Fra­zier had been a reg­u­lar at the White House, along with oth­er top cor­po­rate CEOs in the in­dus­try.

In biotech, though, ex­ecs through­out the small­er com­pa­nies in the in­dus­try have voiced their op­po­si­tion to a num­ber of Trump’s ini­tia­tives, in par­tic­u­lar sin­gling out his stab at in­sti­tut­ing new im­mi­gra­tion poli­cies tar­get­ing sev­er­al Mus­lim-ma­jor­i­ty coun­tries. And it wasn’t long be­fore sup­port for Fra­zier’s move be­gan to pop up on Twit­ter.

Don­ald Trump and Ken Fra­zier dur­ing the an­nounce­ment of a new­ly de­signed phar­ma­ceu­ti­cal glass bot­tle in the Roo­sevelt Room on Ju­ly 20, 2017 SAUL LOEB/AFP/Get­ty Im­ages

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.