Ane­mia spe­cial­ist Ake­bia merges with Keryx on the eve of a block­buster brawl with Fi­bro­Gen

Ake­bia is go­ing in­to its head-to-head late-stage fight with Fi­bro­Gen with a lit­tle more fire­pow­er.

Two months af­ter Keryx $KERX CEO Gre­go­ry Madi­son abrupt­ly re­signed and left the com­pa­ny, the biotech has fol­lowed through to­day by agree­ing to a merg­er with Ake­bia $AK­BA, a biotech with a close­ly-watched ane­mia drug in late-stage de­vel­op­ment.

John But­ler

Click on the im­age to see the full-sized ver­sion

The com­bi­na­tion of the two com­pa­nies will bring to­geth­er two drugs de­signed for pa­tients with chron­ic kid­ney dis­ease. Keryx mar­kets Au­ryx­ia, which ac­count­ed for the li­on’s share of about $22 mil­lion in Q1 rev­enue. That drug is used to fight iron de­fi­cien­cy ane­mia in pa­tients with chron­ic kid­ney dis­ease.

The deal didn’t add up for in­vestors, though. Both biotechs’ shares were down about 25% in mid-day trad­ing.

That down­turn may have had some­thing to do with Ake­bia’s up­date on its de­vel­op­ment time­line, with cru­cial da­ta now not ex­pect­ed un­til 2020. In the view of Jef­feries’ Michael Yee (in Fi­bro­Gen’s camp):

AK­BA has de­layed the Phase III da­ta to 2020, putting the merged com­pa­ny 1-2 years be­hind FGEN, in our view.

Ake­bia, mean­while, has been lin­ing up a slate of glob­al part­ner­ships in an­tic­i­pa­tion of even­tu­al­ly mar­ket­ing vadadu­s­tat to treat ane­mia in CKD pa­tients. But an­a­lysts ex­pect they’ll have a bat­tle on their hands, with many giv­ing the ad­van­tage to Fi­bro­Gen, which start­ed the day with a mar­ket cap 10 times what Ake­bia had.

Greg Madi­son

Just a few weeks ago Fi­bro­Gen and its part­ners at Astel­las re­port­ed that their 4th Phase III study of the ri­val rox­adu­s­tat in Japan had end­ed with pos­i­tive re­sults. And Fi­bro­Gen is well in­to Phase III in the US as well.

Keryx and Ake­bia, mean­while, say that af­ter the merg­er the biotech should be worth $1.3 bil­lion. Keryx share­hold­ers will wind up with a slight ma­jor­i­ty of the new shares while Ake­bia CEO John But­ler will stay at the helm. Keryx will name the chair­man and the com­pa­ny will be called Ake­bia.

All that prob­a­bly ex­plains a lot about Madi­son’s de­par­ture.

But­ler ex­plained his strat­e­gy:

The strate­gic and fi­nan­cial dri­vers of this merg­er are com­pelling. The com­bined com­pa­ny will have an ex­pand­ed and high­ly com­ple­men­tary nephrol­o­gy port­fo­lio, with Au­ryx­ia, a prod­uct with sig­nif­i­cant growth op­por­tu­ni­ty, and vadadu­s­tat, an in­ves­ti­ga­tion­al late-stage HIF-PHI that has the po­ten­tial to pro­vide a new oral stan­dard of care to pa­tients with ane­mia due to CKD. Com­bin­ing Ake­bia and Keryx cre­ates a lead­ing re­nal com­pa­ny and pro­vides it with the in­fra­struc­ture to max­i­mize the mar­ket po­ten­tial of Au­ryx­ia and build launch mo­men­tum for vadadu­s­tat in the Unit­ed States, sub­ject to FDA ap­proval.

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.

Alaa Halawaa, executive director at Mubadala’s US venture group

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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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

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

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

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

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.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

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

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

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.

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