No­var­tis wins big in head-to-head Eylea matchup, set­ting up a loom­ing mar­ket feud with Re­gen­eron

No­var­tis in­ves­ti­ga­tors went head-to-head with Re­gen­eron’s block­buster Eylea in two large Phase III stud­ies. And they scored, scoop­ing up promis­ing top-line re­sults and set­ting up a 2018 fil­ing that puts them on a col­li­sion course with the big biotech.

The phar­ma gi­ant an­nounced this morn­ing that it had hit the pri­ma­ry — non-in­fe­ri­or­i­ty to Eylea — and sec­ondary end­points with RTH258 among 1,800 pa­tients with neo­vas­cu­lar age-re­lat­ed mac­u­lar de­gen­er­a­tion (nAMD) across 400 cen­ters world­wide.

The key for this drug, though, wasn’t non-in­fe­ri­or­i­ty to a drug that earned $3.3 bil­lion last year. No­var­tis’ 6 mg ther­a­py, fre­quent­ly cit­ed as one of its top late-stage drug prospects, worked on a once-every-12-weeks sched­ule for 57% and 52% of the pa­tients in the two tri­als.

Re­gen­eron’s shares $REGN slid 2.5% in pre­mar­ket trad­ing. No­var­tis’ shares jumped 1.5%.

Those fig­ures rep­re­sent a clear vic­to­ry for No­var­tis, as an­a­lysts had stepped back to see just how big a con­cen­tra­tion of pa­tients could achieve equal vi­su­al acu­ity on a 12-week sched­ule com­pared to Eylea’s 8-week reg­i­men.No­var­tis it­self had said it need­ed to get at least 40% of the pa­tients on the 12-week dos­ing sched­ule for this to be a block­buster op­por­tu­ni­ty.

Two months ago, Leerink’s Ge­of­frey Porges not­ed:

Since Eylea is the con­trol arm, and is be­ing giv­en on the stan­dard q8 week sched­ule, there will be the ap­pear­ance of su­pe­ri­or con­ve­nience for some pa­tients, but the per­ceived ad­van­tage for RTH258 will de­pend on what pro­por­tion of pa­tients are ac­tu­al­ly man­aged on the less fre­quent dos­ing sched­ule. If that pro­por­tion is rel­a­tive­ly small (15% or less), then we ex­pect the com­mer­cial ad­van­tage for RTH258 to be mod­est. If the pro­por­tion of pa­tients con­trolled on the longer sched­ule is large (40-50% or high­er), then we ex­pect the com­mer­cial ad­van­tage, and im­pact, to be sig­nif­i­cant.

Leerink’s Sea­mus Fer­nan­dez fol­lowed up with the score to­day: “Based on these re­sults, we ex­pect RTH258 to be a ma­jor com­peti­tor in the US to Eylea and Lu­cen­tis, and es­sen­tial­ly re­place Lu­cen­tis over­seas where NVS con­trols mar­ket­ing.”

That’s not what Re­gen­eron wants to hear right now. While the biotech has racked up back-to-back ap­provals for Dupix­ent and sar­ilum­ab, it’s al­so been strug­gling on the PC­SK9 front, along­side its part­ner Sanofi. Eylea has been a main­stay for the com­pa­ny for years now, fund­ing its rapid growth for the past 6 years. Any mar­ket loss to No­var­tis, which says it should be ready to file its ap­pli­ca­tions next year, would be painful.

Com­pe­ti­tion from Lu­cen­tis has al­ready slowed growth of the fran­chise.

“These re­sults clear­ly and con­vinc­ing­ly demon­strate RTH258 has the po­ten­tial to re­duce in­jec­tion bur­den while pro­vid­ing ex­cel­lent vi­su­al out­comes.  Giv­en our lega­cy in de­vel­op­ing med­i­cines to pre­serve vi­sion, we are pleased that RTH258 car­ries the promise of be­ing the next ma­jor ad­vance­ment for pa­tients with nAMD” said Vas Narasimhan, glob­al head, drug de­vel­op­ment and chief med­ical of­fi­cer, No­var­tis. “Based on these ro­bust da­ta, we are look­ing for­ward to work­ing with reg­u­la­to­ry agen­cies to bring this pi­o­neer­ing treat­ment to pa­tients.”

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.

The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Source: Shutterstock

Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Fau­ci fires back at White House cam­paign to un­der­mine him

Anthony Fauci has called the White House campaign to discredit him “a bit bizarre” and said he stands by his previous statements, even if he has since changed his views.

The NIAID chief — who has received an outpouring of support following reports that the Trump administration has sent a document akin to opposition research to multiple news outlets — spoke with his usual candor in interviews with The Atlantic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.

John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,300+ biopharma pros reading Endpoints daily — and it's free.