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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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