January 25, 2019 11:12 AM EST
News Briefing

Ab­b­Vie shares slide on slid­ing Hu­mi­ra rev­enue; Deer­field is mak­ing a big in­vest­ment in new de­vice star­tups

Shehla Shakoor

Managing Director

→ Ab­b­Vie trig­gered alarm bells on Wall Street to­day as the phar­ma com­pa­ny cit­ed biosim­i­lar com­pe­ti­tion in Eu­rope for a steep de­cline in ex­pect­ed Hu­mi­ra rev­enue. Shares $AB­BV dropped 7% on the news. Sales in Eu­rope are ex­pect­ed to drop 30% this year, though so far Ab­b­Vie has been able to re­tain mar­ket ex­clu­siv­i­ty for the mega-block­buster in the US for some years to come.

→ Deer­field Man­age­ment and Stan Rowe have cre­at­ed a new de­vice in­cu­ba­tor called NXT Bio­med­ical. The in­cu­ba­tor plans to in­vest up to $25 mil­lion over the next 5 years and Deer­field — a pro­lif­ic in­vestor — will al­lo­cate up to $250 mil­lion for 5 to 8 start­up com­pa­nies that emerge from the in­cu­ba­tor.

→ Chi­nese reg­u­la­tors have OK’d a new in­di­ca­tion for Am­gen’s PC­SK9 drug Repatha, adding mar­ket­ing au­tho­riza­tion for ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease to re­duce the risk of my­ocar­dial in­farc­tion, stroke and coro­nary revas­cu­lar­iza­tion.

AUTHOR

Shehla Shakoor

Managing Director

shehla@endpointsnews.com @ShehlaShakoor
Shehla Shakoor on LinkedIn
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March 20, 2023 06:00 AM EDT

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

Sean Dodge

Healthcare Technology Analyst, RBC Capital Markets

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.

Alaa Halawaa, executive director at Mubadala’s US venture group
March 22, 2023 08:00 AM EDT
Bioregnum
Discovery

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Rohan Palekar, 89bio CEO
March 22, 2023 07:00 AM EDT
R&D

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

Kyle LaHucik

Associate Editor

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat
March 22, 2023 06:30 AM EDT
Financing
Startups

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Kyle LaHucik

Associate Editor

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

Endpoints News

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March 22, 2023 07:23 AM EDT
R&D

Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Katherine Lewin

News Reporter

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

Endpoints News

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO
March 21, 2023 07:28 AM EDTUpdated 01:44 PM
People
Startups

Kite's head of re­search leaves for Flag­ship start­up Sonata

Nicole DeFeudis

Editor

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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March 20, 2023 11:47 AM EDTUpdated 11:58 AM
R&D
FDA+

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Max Gelman

Senior Editor

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Josep Bassaganya-Riera, NImmune Biopharma
March 22, 2023 06:00 AM EDTUpdated 06:47 AM
Startups

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

Amber Tong

Senior Editor

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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March 21, 2023 05:42 PM EDTUpdated 2 hours ago
Pharma
Law

NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price

Zachary Brennan

Senior Editor

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.

Ab­b­Vie shares slide on slid­ing Hu­mi­ra rev­enue; Deer­field is mak­ing a big in­vest­ment in new de­vice star­tups

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Kite's head of re­search leaves for Flag­ship start­up Sonata

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price