Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck CEO Ken Fra­zier pre­pares to step down af­ter 29 years, hand­ing the keys to the Keytru­da race car to CFO Robert Davis

Mer­ck CEO Ken Fra­zier has seen a lot in his 29 years at the Ke­nil­worth, NJ-based drug­mak­er, but it was 2020 that gave him a true pub­lic face. Amid a spate of po­lice shoot­ings, Fra­zier emerged as a lead­ing voice in the ar­gu­ment for racial equal­i­ty in health­care and so­ci­ety writ large.

And now, just like that, he’s step­ping away from the helm he has held for 10 years — and could be look­ing at a fu­ture as a high­ly sought-af­ter el­der states­man and truth-teller.

Fra­zier will leave his role as CEO on June 30, step­ping over in­to the ex­ec­u­tive chair­man role in fa­vor of CFO Robert Davis. Davis, a four-year vet­er­an at Mer­ck, comes with a dec­o­rat­ed ré­sumé, in­clud­ing time served as CFO at Bax­ter and 14 years in the ranks at Eli Lil­ly.

Davis will take con­trol as Mer­ck looks in­to a fu­ture with­out its two lodestars — Fra­zier and Roger Perl­mut­ter, the R&D ti­tan re­spon­si­ble in large part for the suc­cess of I/O block­buster Keytru­da. Perl­mut­ter has al­ready hand­ed the reins to Dean Li, the cur­rent dis­cov­ery lead at Mer­ck, sig­nal­ing the phar­ma gi­ant’s in­tent to con­tin­ue the search for the next big Keytru­da fol­low-up. Perl­mut­ter plans to stay on in a non-ex­ec­u­tive di­rec­tor role through mid-2021.

“We have tremen­dous con­fi­dence in Rob’s abil­i­ty to con­tin­ue to fos­ter in­no­va­tion and to team with Dean Li … to dri­ve sci­en­tif­ic ex­cel­lence in­to the fu­ture,” Mer­ck’s lead in­de­pen­dent di­rec­tor Les Brun said in a state­ment. “We are par­tic­u­lar­ly pleased that Ken will con­tin­ue as ex­ec­u­tive chair­man in or­der to work with Rob and Dean to en­sure a smooth tran­si­tion for the com­pa­ny.”

Fra­zier be­gan work at Mer­ck in 1992 as VP, gen­er­al coun­sel and sec­re­tary of what was then the As­tra Mer­ck group. Fol­low­ing a se­ries of pro­mo­tions in the 1990s, Fra­zier jumped to the C-suite in No­vem­ber 2006, tak­ing on the role of ex­ec­u­tive VP and gen­er­al coun­sel. Af­ter a brief stint as VP and pres­i­dent of Mer­ck’s glob­al hu­man health branch, Fra­zier snared the pres­i­dent role in 2010 and quick­ly as­cend­ed to CEO in ear­ly 2011, where he has stayed since.

Fra­zier’s fi­nal years at Mer­ck were marked in large part by pol­i­tics — a role he was not un­fa­mil­iar with giv­en his time on the board of lob­by­ist PhRMA. In 2017, Fra­zier bailed on Pres­i­dent Don­ald Trump’s man­u­fac­tur­ing coun­cil af­ter claim­ing the pres­i­dent hadn’t done enough to con­demn white su­prema­cists who gath­ered at a Char­lottesville, VA ral­ly that claimed the life of a young white woman.

“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,” Fra­zier said in a state­ment at the time. “As CEO of Mer­ck and as a mat­ter of per­son­al con­science, I feel a re­spon­si­bil­i­ty to take a stand against in­tol­er­ance and ex­trem­ism.”

In 2020, Fra­zier’s star as a pub­lic truth-teller on race — he is the on­ly Black man to lead one of the Big Phar­mas — rose even high­er af­ter the death of George Floyd at the hands of Min­neapo­lis po­lice in May. Fra­zier, in a poignant mo­ment, said that Floyd “could be me.”

Jump­ing on a train of pledges for racial equal­i­ty at ma­jor cor­po­ra­tions, Fra­zier pledged to join a coali­tion, dubbed OneTen, to hire 1 mil­lion black work­ers with­in 10 years. He fre­quent­ly called out the un­der­rep­re­sen­ta­tion of black work­ers across health­care, even at his own com­pa­ny.

In tan­dem with his pub­lic work, Fra­zier al­so over­saw the mas­sive suc­cess of Keytru­da, which has tak­en the on­col­o­gy space by storm on the way to $14.4 bil­lion in sales in 2020 — rank­ing just be­hind Ab­b­Vie’s im­munol­o­gy be­he­moth Hu­mi­ra. Un­like Hu­mi­ra, how­ev­er, Keytru­da’s war chest is still grow­ing at a rapid clip — 30% on the year — un­der­scor­ing the I/O drug’s vast suc­cess across a wide range of in­di­ca­tions.

Keytru­da, and par­tic­u­lar­ly Perl­mut­ter’s role in dri­ving suc­cess across its pipeline, was a salve for Fra­zier’s ear­ly years at the top of Mer­ck as prof­its stag­nat­ed in the ear­ly 2010s. Perl­mut­ter’s ar­rival in 2013 and sub­se­quent Keytru­da suc­cess re­freshed Mer­ck’s im­age, but in re­cent years an­a­lysts have wor­ried whether the com­pa­ny has tacked too much of its suc­cess to that one ther­a­py.

Li’s as­sump­tion to R&D chief could help iden­ti­fy the next big tar­get, and he and Davis will be tasked with an­swer­ing con­cerns over Mer­ck’s slim pipeline as well as how to keep Keytru­da on a growth clip as it looks to take over Hu­mi­ra’s top spot.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).