No­var­tis makes its case on why RTH258 can grab a block­buster piece of Re­gen­eron's AMD mar­ket

Vas­ant Narasimhan, No­var­tis’ CEO-des­ig­nate Bloomberg

Soon-to-be No­var­tis $NVS CEO Vas Narasimhan has peeled back the cov­er on more de­tailed Phase III da­ta for their block­buster Eylea ri­val RTH258 (brolu­cizum­ab), ex­plain­ing why he be­lieves the phar­ma gi­ant has a new drug for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion that has proven to be con­sid­er­ably bet­ter than Re­gen­eron’s $5 bil­lion fran­chise ther­a­py Eylea. But he has one oth­er hur­dle to clear be­fore mak­ing a slight­ly paused ar­rival at the FDA.

In a pre­view of da­ta be­ing re­leased at the Amer­i­can Acad­e­my of Oph­thal­mol­o­gy con­fer­ence in New Or­leans, the phar­ma gi­ant’s de­vel­op­ment chief once again hit on the 52% to 57% suc­cess rate for their two big Phase II­Is. That hand­i­ly cleared the 40% to 50% bar need­ed to qual­i­fy for an im­pres­sive suc­cess set by some an­a­lysts cov­er­ing the com­pa­ny.

No­var­tis is bet­ting that mov­ing pa­tients from once every 8 weeks for Re­gen­eron’s flag­ship ther­a­py to a 12-week reg­i­men will win over a big slice of the mar­ket. But they’re back­ing up the ap­peal to pa­tients with a pitch to pay­ers and physi­cians, of­fer­ing ev­i­dence of the drug’s abil­i­ty to re­duce the flu­id that builds up be­hind the reti­na as the dis­ease pro­gress­es, which dam­ages the eye and leads to blind­ness.

“Pay­ers wants to see flu­id is­sues re­solved to make sure the dis­ease is con­trolled,” not­ed Narasimhan in a con­fer­ence call with re­porters. The drug, he ex­plains, is a nov­el an­ti­body frag­ment that is built in a way that al­lows an in­jec­tion to squirt a high con­cen­tra­tion of ther­a­py in­to the eye. Bet­ter pen­e­tra­tion is a key part of its ar­gu­ment that this drug can be more ef­fec­tive at longterm care than Eylea as well as the No­var­tis/Roche drug Lu­cen­tis.

At week 16 the two RTH258 arms had 33% and 35% few­er pa­tients with dam­ag­ing reti­nal flu­id, and at 48 weeks one arm had 41% few­er pa­tients in the dan­ger zone, com­pared to the com­peti­tor. Ac­tive dis­ease was ob­served in 23.5% of brolu­cizum­ab 6 mg pa­tients ver­sus 33.5% of afliber­cept pa­tients in HAWK, and in 21.9% of brolu­cizum­ab pa­tients ver­sus 31.4% of afliber­cept pa­tients in HAR­RI­ER.

The drug, says Narasimhan, “was con­sis­tent­ly su­pe­ri­or to Eylea.” And there’s a lot at stake, with Re­gen­eron tak­ing in $953 mil­lion in US Eylea sales in Q3.

But there is one po­ten­tial hitch. No­var­tis ob­tained the drug through the ac­qui­si­tion of a small com­pa­ny, through which they in­her­it­ed one man­u­fac­tur­ing process. No­var­tis sub­se­quent­ly de­vel­oped its own process and now reg­u­la­tors want the phar­ma team to run some pa­tients through a small test to see if the new process holds up equal­ly well.

As a re­sult, Narasimhan says the com­pa­ny plans to file at the end of next year, rather than hus­tling the drug to the agency now, as most man­u­fac­tur­ers would pre­fer. That’s to­ward the end of the H2 2018 sched­ule that No­var­tis has told in­vestors, putting back any com­mer­cial show­down with Re­gen­eron un­til lat­er in 2019, af­ter Narasimhan moves in­to his new job as­sur­ing in­vestors that the com­pa­ny knows how to de­vel­op big new prod­ucts.

That will buy Re­gen­eron some more time to line up a pos­si­ble com­pet­i­tive re­sponse. They’re work­ing on nes­vacum­ab (Ang2)/Eylea Phase II stud­ies in DME and wet AMD that an­a­lysts are watch­ing close­ly. And a spokesper­son notes that Re­gen­eron is al­so push­ing ahead with its own quar­ter­ly dos­ing reg­i­men of Eylea.

Re­gen­eron is one of the most ag­gres­sive biotechs in the in­dus­try. They won’t sim­ply stand aside as No­var­tis ze­roes in on their big fran­chise.

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.
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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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