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.

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.

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.

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.

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.