Covid-19 roundup: Mer­ck and Ridge­back re­port ear­ly da­ta for an oral an­tivi­ral to fight the pan­dem­ic; Aus­tria pulls a batch of As­traZeneca’s vac­cine af­ter pa­tient death

A cou­ple of months af­ter scrap­ping its Covid-19 vac­cine pro­gram, Mer­ck has read out ear­ly da­ta for an oral an­tivi­ral it’s de­vel­op­ing with Ridge­back Bio­ther­a­peu­tics, which ex­perts say could be the Tam­i­flu of coro­n­avirus treat­ments.

The part­ners say mol­nupi­ravir — in­vent­ed at an Emory Uni­ver­si­ty spin­out — led to a re­duc­tion in pos­i­tive vi­ral cul­ture in Phase IIa sub­jects, ac­cord­ing to pre­lim­i­nary da­ta. The study in­clud­ed 202 non-hos­pi­tal­ized adults who had Covid-19 symp­toms with­in sev­en days of par­tic­i­pa­tion and test­ed pos­i­tive for the virus. On day 5, re­searchers de­tect­ed the virus in the cell cul­tures of ze­ro of 47 mol­nupi­ravir pa­tients, as op­posed to 24% (or 6 of 25) place­bo pa­tients, Ridge­back and Mer­ck an­nounced.

Roy Baynes

The find­ings — while still ear­ly — back a sec­ondary ob­jec­tive, ac­cord­ing to the part­ners. They plan on read­ing out pri­ma­ry ef­fi­ca­cy and safe­ty end­points and ad­di­tion­al sec­ondary ob­jec­tives at an “up­com­ing med­ical meet­ing.”

“The sec­ondary ob­jec­tive find­ings in this study, of a quick­er de­crease in in­fec­tious virus among in­di­vid­u­als with ear­ly COVID-19 treat­ed with mol­nupi­ravir, are promis­ing and if sup­port­ed by ad­di­tion­al stud­ies, could have im­por­tant pub­lic health im­pli­ca­tions, par­tic­u­lar­ly as the SARS-CoV-2 virus con­tin­ues to spread and evolve glob­al­ly,” said William Fis­ch­er, lead in­ves­ti­ga­tor of the study.

Ex­perts com­pared the oral drug, which would be the first of its kind if au­tho­rized in the US, to Tam­i­flu, ac­cord­ing to the Wall Street Jour­nal.

Carl Di­ef­fen­bach

“It’s tan­ta­liz­ing and in­ter­est­ing, but it’s not ex­act­ly 100% com­plete,” Carl Di­ef­fen­bach, di­rec­tor of the Di­vi­sion of AIDS at the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases, told the WSJ. “What we need to con­firm is that there’s clin­i­cal ben­e­fit.”

The com­pa­nies said ad­di­tion­al Phase II and II/III stud­ies are un­der­way.

“We con­tin­ue to make progress in our Phase 2/3 clin­i­cal pro­grams eval­u­at­ing mol­nupi­ravir in both out­pa­tient and hos­pi­tal set­tings and plan to pro­vide up­dates when ap­pro­pri­ate,” said Roy Baynes, Mer­ck Re­search Lab­o­ra­to­ries CMO, and se­nior VP and head of glob­al clin­i­cal de­vel­op­ment.

Aus­tria pulls a batch of As­traZeneca’s vac­cine af­ter pa­tient death 

Aus­tria has pulled one batch of As­traZeneca’s Covid-19 vac­cine from the shelves af­ter a 49-year-old woman died of “se­vere co­ag­u­la­tion dis­or­ders,” ac­cord­ing to the coun­try’s Fed­er­al Of­fice for Safe­ty in Health Care (BASG).

An­oth­er 35-year-old woman giv­en the shot suf­fered a pul­monary em­bolism and is re­cov­er­ing, the BASG said in a state­ment. Both in­ci­dents oc­curred in peo­ple giv­en shots from the same batch of vac­cines in the Low­er Aus­tria dis­trict of Zwet­tl.

The BASG said there’s cur­rent­ly no ev­i­dence the cas­es are tied to the vac­cine. But to be safe, the gov­ern­ment yanked the whole batch and is con­duct­ing an in­ves­ti­ga­tion.

“Based on the known clin­i­cal da­ta, a causal re­la­tion­ship can­not be es­tab­lished, as throm­bot­ic events in par­tic­u­lar are not among the known or typ­i­cal side ef­fects of the vac­cine in ques­tion,” the BASG said. “The im­me­di­ate­ly ini­ti­at­ed in­ter­na­tion­al analy­sis of side ef­fect re­ports al­so shows no ac­cu­mu­la­tion of sim­i­lar case re­ports so far.”

Back in Jan­u­ary, Cal­i­for­nia’s state epi­demi­ol­o­gist called for the sus­pen­sion of more than 300,000 dos­es of Mod­er­na’s vac­cine af­ter few­er than 10 peo­ple who re­ceived shots from the batch suf­fered pos­si­ble al­ler­gic re­ac­tions. Mod­er­na said at the time that it was “un­aware of com­pa­ra­ble ad­verse events from oth­er vac­ci­na­tion cen­ters which may have ad­min­is­tered vac­cines from the same lot,” PBS re­port­ed.

The sus­pen­sions come as vac­cines are in ex­treme­ly short sup­ply, with some health­care ex­perts call­ing them “liq­uid gold.”

Last month, South Africa slammed the brakes on the roll­out of As­traZeneca and Ox­ford Uni­ver­si­ty’s Covid-19 vac­cine af­ter da­ta showed it did not pro­tect against mild-to-mod­er­ate cas­es caused by the B.1.351 vari­ant, which is now wide­spread in the coun­try. The gov­ern­ment lat­er said it’s con­sid­er­ing sell­ing or ex­chang­ing the dos­es it’s al­ready re­ceived.

Ac­cord­ing to a poll from YouGov, one in four Ger­man and French re­spon­dents said they’d refuse to take As­traZeneca’s jab if of­fered.

Vac­citech plans mas­sive IPO, but Ox­ford could stand in the way — re­port

Vac­citech — the spin­out be­hind Ox­ford Uni­ver­si­ty’s Covid-19 vac­cine with As­traZeneca — is re­port­ed­ly lin­ing up a mas­sive Nas­daq de­but. But ten­sion with the uni­ver­si­ty has spilled over in­to pub­lic view, and could prove a chal­lenge in the com­pa­ny’s IPO quest.

Ac­cord­ing to un­named sources and doc­u­ments re­viewed by the Wall Street Jour­nal, Vac­citech is shoot­ing for a $700 mil­lion IPO val­u­a­tion, and the S-1 could come as ear­ly as this year. Big-name play­ers like Gilead and Lil­ly Asia Ven­tures have ex­pressed in­ter­est in in­vest­ing, the WSJ re­port­ed.

But Ox­ford, which owns 10% of the com­pa­ny, could make things a bit dif­fi­cult for Vac­citech. Vac­citech cre­at­ed key tech­nol­o­gy be­hind Ox­ford and As­traZeneca’s Covid-19 vac­cine, which it still owns the rights to. But it gave up di­rect rights to the vac­cine it­self, and is in­stead el­i­gi­ble for 24% of any roy­al­ties Ox­ford gets from vac­cine sales, ac­cord­ing to the WSJ.

Vac­citech now wants Ox­ford’s bless­ing to mar­ket its sci­en­tists’ ear­ly work on the vac­cine’s de­vel­op­ment and man­u­fac­tur­ing, the WSJ re­port­ed. And it wants to see the vac­cine con­tract Ox­ford inked with As­traZeneca, which the com­pa­ny says in­cludes oblig­a­tions that are “key to valu­ing the com­pa­ny fair­ly and for reg­u­la­to­ry dis­clo­sures.”

Ox­ford and its ven­ture firm, Ox­ford Sci­ences In­no­va­tion, to­geth­er own a more than 40% stake in Vac­citech. While some Ox­ford-af­fil­i­at­ed in­vestors pre­fer to list in Lon­don, Vac­citech is gun­ning for a New York list­ing. Ox­ford Uni­ver­si­ty is now in the process of chang­ing its spin­out rules, ac­cord­ing to the WSJ.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.

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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