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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”