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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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