Split the pot? Ra­dius shows its os­teo­poro­sis cards in fi­nal block­buster match with Am­gen

Ra­dius Health $RDUS has tak­en an­oth­er big leap down the fi­nal stretch of its Phase III race with Am­gen $AMGN, post­ing Phase III re­sults that show abaloparatide’s clear clin­i­cal ben­e­fit over a place­bo in treat­ing os­teo­poro­sis. But while the da­ta pro­vide a fresh ar­gu­ment in fa­vor of its near-term ap­proval at the FDA and EMA, there’s still a big ques­tion left unan­swered: Just how com­pet­i­tive will this drug be against Am­gen’s Phase III ri­val, as well as Eli Lil­ly’s ag­ing For­teo? And mean­while, the roll up to the FDA is al­so light­ing a fresh fire un­der the heat­ed de­bate over the cost of drugs, both old and new.

First, the num­bers, pub­lished in the Jour­nal of the Amer­i­can Med­ical As­so­ci­a­tion. In a large Phase III tri­al, just four of 824 pa­tients tak­ing Ra­dius’s abaloparatide suf­fered a spinal frac­ture af­ter 18 months. In a place­bo arm, that po­ten­tial­ly dev­as­tat­ing event was ex­pe­ri­enced by 30 pa­tients—giv­ing the ex­per­i­men­tal drug a clear ad­van­tage. But in the For­teo arm with 818 pa­tients, there were 6 spinal frac­tures. That’s slight­ly worse, but the study wasn’t large enough to show a clear dif­fer­ence be­tween the stan­dard of care and the new drug.

Pa­tients on the Ra­dius Health drug al­so ex­pe­ri­enced im­prove­ments in bone min­er­al den­si­ty. In­ves­ti­ga­tors in the study con­cen­trat­ed on old­er women with a his­to­ry of frac­tures, the at-risk pop­u­la­tion that the drug is pri­mar­i­ly aimed at, though it is be­ing stud­ied in oth­er pop­u­la­tions as well.

Not in­clud­ed in this matchup is Am­gen’s ro­mosozum­ab, it’s own bone-build­ing drug that was filed for an ap­proval on Ju­ly 21. Am­gen is part­nered with UCB on the drug. Back in Feb­ru­ary, in­ves­ti­ga­tors not­ed that their Phase III study came out with a 73% re­duc­tion in the risk of frac­tures, which paled a bit in re­la­tion to Ra­dius’s 86% risk re­duc­tion. That sparked a de­bate among an­a­lysts whether Am­gen’s drug could dis­tin­guish it­self with a much eas­i­er dos­ing reg­i­men — once month­ly ver­sus once dai­ly.

An­a­lysts’ peak sales pro­jec­tions have been all over the map. Deutsche Bank last year pegged aba­lo’s peak at $1.1 bil­lion, though they be­lieved that ro­mo would come out on top as the bet­ter drug with a big­ger mar­ket share, de­pend­ing on how the gener­ics shake out.

While both Am­gen and Ra­dius stand a good chance of win­ning an ap­proval, com­mer­cial suc­cess is a com­plete­ly dif­fer­ent is­sue. As The New York Times re­ports, pa­tients are gen­er­al­ly start­ed on bis­pho­s­phanates like Fos­amax, which are old and cheap. But they’re al­so lim­it­ed, un­able to build bone the way For­teo and the two 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 6 years.

Now the ques­tion is whether the new drugs will cost as much or more than For­teo, which is gen­er­al­ly lim­it­ed to two years of ther­a­py due to fears about po­ten­tial can­cer risks. And in­sur­ers – who are like­ly to re­strict ac­cess to these drugs to pa­tients with the high­est risk fac­tors – have grown leery about cov­er­ing the Lil­ly drug, of­ten re­quir­ing big co-pays from pa­tients.

Dr. Do­lores Shoback

Dr. Do­lores Shoback, a pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, told the Times:

“The cost in the pri­vate sec­tor is get­ting pro­hib­i­tive. You have to hunt for a rea­son, find a very strong rea­son that is iron­clad,” to get an in­sur­er to ap­prove For­teo, she added. “We find it can be ex­treme­ly dif­fi­cult to get it cov­ered.”

Ra­dius may have just high­light­ed a clear path to an ap­proval. But po­si­tion­ing this drug to win the four-way com­mer­cial pok­er match ahead is far more prob­lem­at­ic.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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