With No­var­tis clos­ing in, Re­gen­eron scraps Eylea com­bo drug in a ma­jor set­back

Just a few weeks af­ter No­var­tis $NVS spelled out ex­act­ly why it be­lieves RTH258 can carve out a block­buster chunk of Re­gen­eron’s AMD mar­ket for Eylea, its big ri­val says that a next-gen com­bo won’t be rid­ing to their res­cue.

Ear­ly Mon­day Re­gen­eron $REGN said both Phase II stud­ies of nes­vacum­ab — an an­giopoi­etin2 (Ang2) an­ti­body — in com­bi­na­tion with Eylea failed to beat a so­lo ver­sion of their flag­ship ther­a­py. And that’s forc­ing both Re­gen­eron and its al­lies at Bay­er — which paid $50 mil­lion up­front to part­ner here — to drop Phase III plans.

The com­bi­na­tion “did not pro­vide suf­fi­cient dif­fer­en­ti­a­tion to war­rant Phase III de­vel­op­ment,” Re­gen­eron not­ed in a short state­ment. The da­ta will have to wait for an up­com­ing sci­en­tif­ic con­fer­ence.

Re­gen­eron shares dropped 2.5% in pre-mar­ket trad­ing on Mon­day.

The lat­est set­back at Re­gen­eron for their oph­thal­mol­o­gy group comes a lit­tle more than a year af­ter its an­ti-PDGF an­ti­body rin­u­cum­ab com­bined with its block­buster drug failed a Phase II for age-re­lat­ed mac­u­lar de­gen­er­a­tion. There was a slight im­prove­ment in vi­sion, but it wasn’t enough to make a com­mer­cial dif­fer­ence for Re­gen­eron.

Ear­li­er this month, No­var­tis de­vel­op­ment chief Vas Narasimhan spelled out a key suc­cess for RTH258 from their am­bi­tious late-stage de­vel­op­ment ef­fort. 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. And there’s a lot at stake, with Re­gen­eron tak­ing in $953 mil­lion in US Eylea sales in Q3.

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. Re­gen­eron, mean­while, is left with their own pro­gram to demon­strate suc­cess with a quar­ter­ly in­jec­tion of Eylea.

Back-to-back set­backs like this are un­usu­al for Re­gen­eron, which has en­joyed a se­ries of de­vel­op­ment suc­cess­es. CSO and co-founder George Yan­copou­los, though, says it’s hard to im­prove on a drug like Eylea, adding that the com­pa­ny is still hard at it in oph­thal­mol­o­gy.

We ex­pect to re­port re­sults in the first half of 2018 from our EYLEA Phase III study in di­a­bet­ic retinopa­thy, which rep­re­sents a grow­ing pa­tient pop­u­la­tion with sig­nif­i­cant need. We al­so con­tin­ue to in­vest in ad­di­tion­al R&D ap­proach­es in oph­thal­mol­o­gy with the goal of pro­vid­ing new in­no­va­tions to pa­tients with se­ri­ous vi­sion-threat­en­ing dis­eases.


Im­age: Re­gen­eron R&D Chief George Yan­copou­los Get­ty

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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