John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As John­son & John­son con­tin­ues to roll out its Covid-19 shot, the com­pa­ny is al­so fo­cused on an­oth­er vac­cine.

J&J is do­nat­ing up to 200,000 dos­es of its Ebo­la vac­cine reg­i­men de­vel­oped with Bavar­i­an Nordic to help health au­thor­i­ties deal with a new out­break in Sier­ra Leone. The reg­i­men, Zab­de­no and Mv­abea, was grant­ed pre­qual­i­fi­ca­tion by the WHO in April, which will help ac­cel­er­ate its reg­is­tra­tion in coun­tries where Ebo­la is a threat.

Of­fi­cials in Guinea of­fi­cial­ly de­clared a new Ebo­la out­break back in Feb­ru­ary, af­ter the coun­try record­ed its first cas­es since the end of the 2014 to 2016 out­break. It ap­pears the new out­break was caused by the same strain, and of­fi­cials say it was like­ly in­tro­duced by a sur­vivor. There have been at least 12 deaths, J&J an­nounced.

“John­son & John­son’s vi­sion is to help pre­vent Ebo­la out­breaks be­fore they start,” CSO Paul Stof­fels said in a state­ment. “WHO Pre­qual­i­fi­ca­tion of our vac­cine reg­i­men and the de­ploy­ment to West Africa are im­por­tant steps for­ward in reach­ing this goal and an im­por­tant mile­stone for epi­dem­ic pre­pared­ness.”

Ji Xing promis­es more than $127M for Mile­stone’s nasal spray for rapid heart rate

Mile­stone Phar­ma hit a ma­jor snag last March when its nasal spray for episodes of rapid heart rate missed the pri­ma­ry end­point. Now, more than a year lat­er, it’s tout­ing new da­ta on its sec­ondary end­points and a part­ner­ship with Ji Xing Phar­ma­ceu­ti­cals to de­vel­op the can­di­date in Chi­na.

Ji Xing is pay­ing $15 mil­lion up­front and mak­ing a $5 mil­lion eq­ui­ty in­vest­ment for the rights to de­vel­op and com­mer­cial­ize etri­pamil, a fast-act­ing cal­ci­um chan­nel block­er, in Greater Chi­na, the com­pa­nies said on Mon­day. If all goes well, Mile­stone stands to re­ceive up to $107.5 in mile­stones and roy­al­ties.

At ACC 2021, Mile­stone said etri­pamil had high­er scores than place­bo re­lat­ed to re­lief of spe­cif­ic symp­toms as­so­ci­at­ed with parox­ys­mal supraven­tric­u­lar tachy­car­dia (PSVT), in­clud­ing rapid pulse (p=0.002), pal­pi­ta­tions (p<0.001), short­ness of breath (p=0.008), dizzi­ness (p=0.012), and anx­i­ety (p=0.006), Mile­stone said at ACC 2021.

But last year, the drug failed on the pri­ma­ry end­point in a Phase III study: a com­par­i­son of the nasal ther­a­py with place­bo over 5 hours in turn­ing SVT to si­nus rhythm. It fell far short of the mark on sta­tis­ti­cal sig­nif­i­cance with a val­ue of 0.12. It al­so fell short on re­duc­ing trips for emer­gency care, with the same p-val­ue.

“Etri­pamil holds the po­ten­tial to en­able pa­tients to treat their episodes in the at-home set­ting and ul­ti­mate­ly take con­trol of their con­di­tion. We re­main fo­cused on the ex­e­cu­tion of our on­go­ing Phase 3 pro­gram and our vi­sion to help pa­tients suf­fer­ing from episodes of SVT,” CEO Joseph Olive­to said in a state­ment.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Au­to­lus claims a CAR-T win at EHA; Ima­go touts two PhII tri­al wins for rare dis­ease drug

Presentations at the European Hematology Association began Friday, with Autolus Therapeutics revealing data they say continue to show the benefit of their CAR-T program.

The Autolus program, known as 0be-cel, achieved a 100% complete remission rate in a cohort of indolent B Cell Non-Hodgkin lymphoma patients, with all nine treated patients hitting the mark as of the May 17 cutoff. Another three patients are still awaiting treatment, while a fourth enrolled individual died due to a Covid-19 infection.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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Verona signs Chi­na deal for PhI­II COPD drug; Te­va con­tin­ues le­gal bat­tle with Eli Lil­ly, al­leg­ing new patent in­fringe­ments on mi­graine drug

After a February Phase II win put Verona’s bad memories of a 2019 flop behind them, the company is now engaging in partnerships to ship out the experimental drug should it continue to produce positive results in Phase III.

Verona is teaming up with Nuance Pharma on a $219 million collaboration to commercialize ensifentrine in China, Macau Hong Kong and Taiwan, the companies announced Thursday. The deal includes $25 million in upfront cash and a $15 million equity stake in Nuance Biotech, the parent company of Nuance Pharma. Verona is eligible for up to $179 million in milestones.