Bris­tol My­ers flash­es a thumbs-up on piv­otal push to ex­pand Abec­ma's BC­MA CAR-T mar­ket

Bris­tol My­ers Squibb and their part­ners at 2sev­en­ty bio have flagged a top-line win for Kar­M­Ma-3, one in a se­ries of piv­otal stud­ies look­ing to move Abec­ma (ide­cab­ta­gene vi­cleu­cel) up the line to ear­li­er-stage mul­ti­ple myelo­ma pa­tients.

We won’t get the hard da­ta un­til lat­er in the year, but for now, the phar­ma gi­ant and its biotech mar­ket­ing side­kick want you to know that Abec­ma scored on sta­tis­ti­cal sig­nif­i­cance for third-line pa­tients on the pri­ma­ry end­point: su­pe­ri­or pro­gres­sion-free sur­vival com­pared to stan­dard of care.

Steve Bern­stein

Bris­tol My­ers is now tak­ing the da­ta to reg­u­la­tors, where they stand an odds-on chance of a quick sup­ple­men­tal ap­proval.

“These re­sults help to ad­vance our ef­forts to make Abec­ma avail­able for ear­li­er lines of treat­ment for pa­tients and we look for­ward to dis­cussing these re­sults with reg­u­la­to­ry au­thor­i­ties,” said Steve Bern­stein, the chief med­ical of­fi­cer at 2sev­en­ty bio.

That should put Bris­tol My­ers one step ahead in the race with J&J and Leg­end, which field­ed their ri­val BC­MA CAR-T Carvyk­ti about five months ago. The J&J/Leg­end drug may have been sec­ond to mar­ket, but it looks like a first-in-class play­er to a bevy of an­a­lysts who tracked both ther­a­pies through the clin­ic.

Yaron Wer­ber

Bris­tol My­ers has em­bold­ened its back­ers on Wall Street with a nice beat on Q2 rev­enue for Abec­ma, com­ing in at $72 mil­lion — $6 mil­lion over con­sen­sus, notes Cowen’s Yaron Wer­ber. And Wer­ber ex­pects that fig­ure to con­tin­ue to grow, while Carvyk­ti looks to play catch-up. Notes Wer­ber:

No­tably, Carvyk­ti and Abec­ma both post­ed $24M in sales in their first quar­ters on the mar­ket, sug­gest­ing sim­i­lar ini­tial launch­es.

Bris­tol My­ers and 2sev­en­ty, mean­while, have more piv­otal stud­ies un­der­way to keep press­ing their first-to-mar­ket ad­van­tage. Sec­ond-line da­ta should come lat­er in the year. And J&J/Leg­end are breath­ing down their necks.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

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Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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