UP­DAT­ED: 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.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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