Shift to dig­i­tal leaves hun­dreds of Am­gen sales jobs on chop­ping block

The pan­dem­ic has led to “last­ing changes” in the way Am­gen does busi­ness, CEO Robert Brad­way said while open­ing the com­pa­ny’s year-end sales call on Tues­day. And as a re­sult of those changes, sev­er­al hun­dred US jobs are on the chop­ping block.

The cuts are ex­pect­ed to be­gin on April 2, and will pri­mar­i­ly af­fect the US sales force, Am­gen con­firmed via email. The moves po­si­tion the com­pa­ny to make ad­di­tion­al in­vest­ments in prod­uct launch­es and R&D, a spokesper­son said.

“We made these changes to bet­ter en­able Am­gen to make ad­di­tion­al in­vest­ments we be­lieve are need­ed to take ad­van­tage of pa­tient-fo­cused op­por­tu­ni­ties, in­clud­ing launch­ing new prod­ucts, and in­vest­ing in R&D,” a state­ment read. “These de­ci­sions are nev­er easy, and we are com­mit­ted to help­ing those im­pact­ed with tran­si­tion­al sup­port.”

SVB Leerink’s Ge­of­frey Porges brought the top­ic of com­mer­cial re­duc­tions dur­ing the Q&A por­tion of Tues­day’s call, ask­ing how they would play out in a “post-Covid world.”

“Wouldn’t you ex­pect to have to ramp back up once we elim­i­nate so­cial dis­tanc­ing?” he asked.

Mur­do Gor­don, EVP of glob­al com­mer­cial op­er­a­tions, said “a cou­ple of fac­tors” went in­to the re­or­ga­ni­za­tion, in­clud­ing the piv­ot to prod­uct launch­es and a shift to dig­i­tal that he be­lieves will per­sist be­yond the pan­dem­ic.

“What we’re do­ing is look­ing at our over­all com­mer­cial mod­el, and… mak­ing it more pro­duc­tive and mak­ing it more ef­fi­cient,” Gor­don replied.

“It’s that per­sis­ten­cy that we’re bet­ting on. What we haven’t done is com­pro­mised the abil­i­ty to have com­pet­i­tive share of voice in our field fac­ing in­ter­ac­tions both on the med­ical side (and) on the com­mer­cial side in front of the cus­tomer,” he added lat­er.

De­spite the US cut­backs, the com­pa­ny is plac­ing “large in­vest­ments” in the field force in Japan, Chi­na and Rus­sia, Gor­don said.

For the full year, Am­gen re­port­ed a rev­enue in­crease of 9% to $25.4 bil­lion —though not­ed that the growth was par­tial­ly off­set by low­er net sell­ing prices and the pan­dem­ic. An­a­lysts ze­roed in on Am­gen’s “break­through” KRAS G12C drug so­tora­sib, which got at­ten­tion last week when the biotech un­veiled a round of da­ta from a piv­otal study in non-small cell lung can­cer. They al­so took note of Am­gen’s asth­ma drug teze­pelum­ab, which is ex­pect­ed to go be­fore reg­u­la­tors in the first half of this year.

“We are big be­liev­ers in both of these ther­a­pies as so­tora­sib should have a rapid launch giv­en the un­met need and 6-12 months lead to mar­ket over Mi­rati’s ada­gra­sib,” Cowen’s Yaron Wer­ber and Bren­dan Smith said in a note to in­vestors.

“Am­gen’s ear­ly stage pipeline, how­ev­er, con­tin­ues to be slug­gish. In par­tic­u­lar, the BiTE pro­gram needs val­i­da­tion amid on­go­ing set­backs – now in­clud­ing the en­roll­ment pause for AMG 701 (BC­MA for RRMM), stop­ping Ph1 for AMG 596 (EGFR vI­II for glioblas­toma), on­go­ing chal­lenges to the CD33 pro­grams for AML, and slow progress with MCL 1.”

Porges wrote that he be­lieves ex­pec­ta­tions for so­tora­sib and teze­pelum­ab are “large­ly priced in, and there are on­ly so many ques­tions an­a­lysts can ask about com­bi­na­tion strate­gies and sec­ondary tu­mor tri­al time­lines.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.

Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

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