Mer­ck’s $1B cash gam­ble pays off with a sur­pris­ing PhI­II car­dio suc­cess for Bay­er’s heart drug veri­ciguat

More than 3 years af­ter Mer­ck stepped up and paid $1 bil­lion in cold, hard cash to gain the US com­mer­cial rights to Bay­er’s high-risk heart drug veri­ciguat in a broad-rang­ing car­dio al­liance, the part­ners say their Phase III study has come through with promis­ing da­ta and a date with reg­u­la­tors.

We don’t have the da­ta, and won’t un­til they put it out at an up­com­ing sci­en­tif­ic ses­sion, but Mer­ck tout­ed the re­sults, say­ing that their big Phase III VIC­TO­RIA study hit the pri­ma­ry end­point  — with veri­ciguat com­bined with avail­able ther­a­pies re­duc­ing “the risk of the com­pos­ite end­point of heart fail­ure hos­pi­tal­iza­tion or car­dio­vas­cu­lar death in pa­tients with wors­en­ing chron­ic heart fail­ure with re­duced ejec­tion frac­tion (HFrEF) com­pared to place­bo when giv­en in com­bi­na­tion with avail­able heart fail­ure ther­a­pies.”

De­pend­ing on the hard da­ta, and how it breaks out with the com­bi­na­tions used, this drug could pose a threat to No­var­tis’ block­buster drug En­tresto, cur­rent­ly at $1.6 bil­lion while an­a­lysts ex­pect peak sales to hit $4 bil­lion.

The drug is a sol­u­ble guany­late cy­clase (sGC) stim­u­la­tor, which Bay­er and Mer­ck have had high hopes for. Ev­i­dent­ly, so did car­di­ol­o­gists. Cowen’s last analy­sis set po­ten­tial sales at $400 mil­lion in 2024, but that num­ber could go up sig­nif­i­cant­ly now.

Cowen’s Steve Scala not­ed this morn­ing:

Veri­ciguat could be a lu­cra­tive prod­uct for Mer­ck, and one with po­ten­tial­ly un­der-ap­pre­ci­at­ed val­ue. At Cowen’s Ther­a­peu­tics Con­fer­ence in Sep­tem­ber 2019, 80% of spe­cial­ists an­tic­i­pat­ed a pos­i­tive re­sult from VIC­TO­RIA where­as on­ly 51% of in­vestors shared this op­ti­mism.

In­ves­ti­ga­tors re­cruit­ed more than 5,000 pa­tients at more than 600 cen­ters in 42 coun­tries for this study — one of the most ex­pen­sive propo­si­tions in R&D. Mil­lions of peo­ple in the US suf­fer from heart fail­ure with re­duced ejec­tion frac­tion when the fail­ing heart fails to con­tract prop­er­ly to eject blood in­to the sys­tem. Bay­er holds ex-US rights to the drug and al­so stands to earn cash from the $1.1 bil­lion in mile­stones Mer­ck agreed on for their col­lab­o­ra­tion.

Re­mark­ably, the drug was pushed in­to Phase III de­spite fail­ing the mid-stage tri­al — though in­ves­ti­ga­tors flagged a suc­cess at the high dose of 10 mg. In VIC­TO­RIA, re­searchers start­ed pa­tients at 2.5 mg and then titrat­ed up to 5 and then 10 mg.

The suc­cess here marks the lat­est in a se­ries of col­lab­o­ra­tive wins for Mer­ck, which en­joys these oc­ca­sion­al splurges. One of their biggest suc­cess­es has been tied to As­traZeneca’s Lyn­parza, where they’ve been pur­su­ing an ac­tive sched­ule of new tri­als aimed at ex­pand­ing use.

“VIC­TO­RIA is the first large con­tem­po­rary out­comes study to fo­cus ex­clu­sive­ly on a pop­u­la­tion with wors­en­ing chron­ic heart fail­ure who have a high risk for car­dio­vas­cu­lar mor­tal­i­ty and re­peat­ed heart fail­ure hos­pi­tal­iza­tions. We are pleased veri­ciguat met this pri­ma­ry end­point and look for­ward to shar­ing the de­tailed find­ings of the study,” said Mer­ck CMO Roy Baynes in a state­ment.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

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

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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Mer­ck touts new da­ta for Keytru­da com­bos in NSCLC at North Amer­i­can con­fer­ence

Merck marched out new data from two studies on Friday to back king Keytruda — the drug that made the Big Pharma $11.1 billion last year — in advanced non-small cell lung cancer (NSCLC).

At the IASLC 2020 North America Conference on Lung Cancer, Merck read out long-term data from Cohort G of its Keynote-021 study, which assessed Keytruda in combination with chemotherapy. It also touted results from a Phase I/II study testing Keytruda and quavonlimab, its anti-CTLA-4 therapy, as a first-line therapy.

News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.

James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.