Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis snaps up the rights to a Covid-19 an­tivi­ral af­ter see­ing mid-stage re­sults. So where are the da­ta?

Near­ly two months af­ter get­ting the boot from the NIH’s AC­TIV-3 study over a failed fu­til­i­ty analy­sis, No­var­tis and Mol­e­c­u­lar Part­ners are back with mid-stage re­sults they say prove their Covid-19 an­tivi­ral works bet­ter in pa­tients who aren’t hos­pi­tal­ized — and CEO Vas Narasimhan likes what he sees.

The phar­ma gi­ant is putting down more than $162 mil­lion to in-li­cense enso­vibep from Mol­e­c­u­lar Part­ners af­ter the can­di­date met its pri­ma­ry end­point of vi­ral load re­duc­tion over eight days in the first part of a Phase II/III study, the part­ners an­nounced on Mon­day.

Mol­e­c­u­lar Part­ners’ stock $MOLN got a rough­ly 20% boost on the news, pric­ing in at $19.92 on Mon­day morn­ing.

Michael Stumpp

How­ev­er, the part­ners have yet to re­veal any hard da­ta on the pri­ma­ry end­point. In fact, the on­ly da­ta point they did re­port on was a 78% re­duc­tion in the risk of Covid-re­lat­ed hos­pi­tal­iza­tion, ER vis­its and death com­pared to place­bo (a sec­ondary end­point), which Mol­e­c­u­lar COO and co-founder Michael Stumpp said was sta­tis­ti­cal­ly sig­nif­i­cant. If you take ER vis­its out of that equa­tion, the an­tivi­ral re­port­ed an 87% re­duced risk in hos­pi­tal­iza­tion and death com­pared to place­bo, CEO Patrick Am­stutz said.

A to­tal of 407 non-hos­pi­tal­ized adults with Covid-19 were en­rolled in Part A of the Phase II/III EM­PA­THY study, which test­ed three dif­fer­ent dos­es of enso­vibep (75mg, 225mg and 600mg). In the place­bo arm with 99 pa­tients, there were six events (event rate of 6.0%); five pa­tients were hos­pi­tal­ized, two of whom died due to wors­en­ing of Covid-19, and one pa­tient had an ER vis­it on­ly. But on­ly four of 301 pa­tients across the enso­vibep arms (1.3%) saw such events, and no pa­tients in the enso­vibep arm died, ac­cord­ing to No­var­tis.

Re­searchers al­so re­port­ed a ben­e­fit in time to sus­tained clin­i­cal re­cov­ery, an­oth­er sec­ondary end­point, which Stumpp said was sta­tis­ti­cal­ly sig­nif­i­cant. More da­ta will be pre­sent­ed at a sci­en­tif­ic con­gress lat­er this year, a No­var­tis spokesper­son told End­points News.

Enso­vibep main­tained “po­tent in vit­ro pan-vari­ant ac­tiv­i­ty against all vari­ants of con­cern iden­ti­fied so far, in­clud­ing Omi­cron,” No­var­tis said in a state­ment.

The phar­ma has cho­sen to pro­ceed with the low­est dose, 75 mg, and aims to en­roll an­oth­er 1,700 pa­tients in Part B, the Phase III por­tion of the study. But even with­out the Phase III da­ta, Narasimhan is al­ready talk­ing about plans to file for an EUA.

“We are now re­view­ing the topline re­sults from EM­PA­THY Part A to de­ter­mine next steps for the de­vel­op­ment pro­gram and a strat­e­gy for reg­u­la­to­ry sub­mis­sions to ob­tain fast-track ap­provals. Fol­low­ing re­view of the re­sults, we plan to ini­ti­ate EM­PA­THY Part B as quick­ly as pos­si­ble, with the low­est ef­fec­tive dose iden­ti­fied in Part A of 75mg,” a spokesper­son said.

No­var­tis was not avail­able for an in­ter­view as of press time.

Patrick Am­stutz

The com­pa­ny bought in­to the enso­vibep pro­gram back in Oc­to­ber 2020, putting down $22 mil­lion up­front and an­oth­er $44 mil­lion for a chunk of eq­ui­ty. In May, the com­pa­ny launched a Phase II/III tri­al, spon­sored by Mol­e­c­u­lar Part­ners, to test the can­di­date in ear­ly-stage Covid pa­tients. Now, No­var­tis is ex­er­cis­ing its op­tion to snap up the rights, which will cost it rough­ly an­oth­er $162 mil­lion plus “sig­nif­i­cant roy­al­ties” on sales.

“These en­cour­ag­ing re­sults come at a time when the need for ther­a­pies with pan-vari­ant ac­tiv­i­ty, such as enso­vibep, has nev­er been greater,” Am­stutz said in a state­ment.

It hasn’t been smooth sail­ing for enso­vibep, which was kicked out of the NIH’s AC­TIV-3 study back in No­vem­ber af­ter fail­ing a fu­til­i­ty analy­sis in hos­pi­tal­ized Covid-19 pa­tients.

The mol­e­cule comes from a class of drugs de­vel­oped by Mol­e­c­u­lar Part­ners that aims to per­form the same func­tions as an­ti­bod­ies with far more tar­get speci­fici­ty and an­tivi­ral pro­tec­tion. Though the DARPin can­di­date ap­peared safe, it failed to show ef­fi­ca­cy at day 5, when a to­tal of 470 pa­tients were as­sessed on their need for sup­ple­men­tal oxy­gen, me­chan­i­cal ven­ti­la­tion or oth­er sup­port­ive care.

“It could very well be, that’s the op­ti­mistic part, that in sub­groups there is some­thing. But at the same time, it’s such a dif­fi­cult and het­ero­ge­neous set­ting, that maybe the fu­til­i­ty was the right point to say, ‘Let’s re­think, let’s look at the da­ta,” Stumpp said.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Dominic Borie, Kyverna Therapeutics CEO

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Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

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Graphic: Alexander Lefterov for Endpoints News

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Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

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Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.