With Am­gen hot on its heels, Ra­dius races to get a jump on os­teo­poro­sis drug ri­val­ry

This week, Ra­dius Health $RDUS will open a brand new chap­ter in its his­to­ry, armed with an FDA ap­proval for its os­teo­poro­sis drug Tym­los (abaloparatide).

Bob Ward, Ra­dius Health

Ra­dius is launch­ing its very first drug on­to the mar­ket, about to set the price on their ther­a­py (that ar­rives ear­ly Mon­day) and map­ping out a com­mer­cial strat­e­gy that will have to take in­to ac­count Eli Lil­ly’s ag­ing For­teo with the ri­val ro­mosozum­ab from Am­gen and UCB be­ing steered in­to a Ju­ly 19 PDU­FA date.

Leerink’s Ge­of­frey Porges thinks that Ra­dius and Am­gen might fo­cus their com­mer­cial strate­gies on dif­fer­ent mar­kets, with Ra­dius fol­low­ing its da­ta sug­gest­ing greater ef­fi­ca­cy for re­duc­ing the risk of non-ver­te­brae frac­tures for post­menopausal women vs Am­gen’s fo­cus on ver­te­brae frac­tures, which could po­ten­tial­ly boost sales for Am­gen to $868 mil­lion in 2023.

Ra­dius’ drug sliced the risk of ver­te­brae frac­tures 86% and non-ver­te­brae frac­tures 43% com­pared with place­bo. The ab­solute risk re­duc­tions were 3.6% and 2.0%, re­spec­tive­ly. The la­bel in­cludes a warn­ing for women who are at risk of bone sar­co­mas.

Am­gen, mean­while, tracked a 73 per­cent re­duc­tion in the rel­a­tive risk of a new ver­te­brae (spine) frac­ture through 12 months but missed sta­tis­ti­cal sig­nif­i­cant on non-vertabrae frac­tures.

“While FDA ap­proval is pos­i­tive, we con­tin­ue to see sig­nif­i­cant com­mer­cial hur­dles as like­ly giv­en com­pe­ti­tion (For­teo on mar­ket; ro­mosozum­ab PDU­FA date of 7/19/17; po­ten­tial gener­ic For­teo en­try in 2019),” not­ed Eun Yang at Jef­feries. “In ad­di­tion, wide use of Am­gen’s (AMGN, Hold) Pro­lia has been de­lay­ing use of an­a­bol­ic agents (e.g., For­teo, Tym­los).”

The way Ra­dius CEO Bob Ward looks at this, it’s not about watch­ing the mar­ket frag­ment by ver­te­brae and non-ver­te­brae frac­ture risk. Ra­dius is go­ing af­ter the en­tire mar­ket, in­clud­ing a move in­to front­line use for physi­cians and pa­tients who want to get a jump on bone build­ing. As for dos­ing reg­i­mens, he’s hap­py with his chances of a self-ad­min­is­tered drug ver­sus one you get at the doc­tor’s of­fice (which is ro­mo, For­teo is self-ad­min­is­tered like Tym­los).

“I don’t think the mar­ket re­al­ly seg­ments on site of frac­ture,” he tells me. “It will on pa­tients that want to self-ad­min­is­ter.”

And where an­a­lysts see the com­pet­i­tive land­scape shift­ing dra­mat­i­cal­ly over the year as Am­gen and UCB line up ro­mo, Ward sees a low com­pet­i­tive en­vi­ron­ment, par­tic­u­lar­ly af­ter Mer­ck and Lil­ly both scrapped po­ten­tial ri­vals, with a like­ly 10-year run at cap­i­tal­iz­ing on the ap­proval as the biotech brings along oth­er drugs in the pipeline.

As for peak sales pro­jec­tions, Ward is quick to note that this is a big mar­ket, and every drug ap­proved for it has gone on to block­buster sta­tus. He’s re­cruit­ed a sales force of more than 200 to tack­le the US mar­ket, and he’s in the process of strik­ing a Eu­ro­pean part­ner­ship to han­dle that launch, ex­pect­ed lat­er in the year.

An­a­lysts don’t nec­es­sar­i­ly agree. Eval­u­atePhar­ma’s sell-side con­sen­sus on Tym­los es­ti­mat­ed 2022 rev­enue at $467 mil­lion. And some an­a­lysts have been point­ing to the rad­i­cal­ly dif­fer­ent dos­ing sched­ules — Am­gen at once a month, Ra­dius dai­ly — as like­ly to have an im­pact on the race in Am­gen’s fa­vor.

As The New York Times re­port­ed re­cent­ly, pa­tients are gen­er­al­ly start­ed on bis­pho­s­pho­nates like Fos­amax, which are old and cheap. But they’re al­so lim­it­ed, un­able to build bone the way For­teo and these new drugs are de­signed to do.

Lil­ly, mean­while, has been rapid­ly jack­ing up the price of For­teo ahead of its loss of patent pro­tec­tion. The Times re­ports that the whole­sale price has soared to $3,100 a month, more than three times its price in 2010. Lil­ly has been in­creas­ing the price twice a year, for six years. And they’ve had plen­ty of time to eval­u­ate how best to counter new en­tries with the ar­rival of drugs from Ra­dius and Am­gen this year.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

‘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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: CMS to re­strict cov­er­age of Bio­gen's con­tro­ver­sial Alzheimer's drug to on­ly clin­i­cal tri­als

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.