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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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