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 Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

ViiV Healthcare and majority owner GlaxoSmithKline have cleared another important hurdle on a long-running quest to challenge Gilead’s dominance in preventative HIV treatments.

The final analysis of a new study shows the GSK subsidiary’s long-lasting injection, cabotegravir, proved 66% more effective in HIV prevention than Gilead’s breakthrough Truvada pill. And they now intend to carve away some of the blockbuster revenue that Gilead has enjoyed for years.

→ Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.