Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

Covid-19 roundup: As­traZeneca launch­es new virus R&D di­vi­sion; US buys more of Mer­ck­'s an­tivi­ral pill

As­traZeneca is launch­ing a new di­vi­sion to en­com­pass its vac­cine and an­ti­bod­ies busi­ness­es.

The sub­unit will fo­cus on its Covid-19 vac­cine and long-act­ing an­ti­body com­bi­na­tion, a com­pa­ny spokesper­son told End­points News in an email, as As­traZeneca looks to move past its ear­ly pan­dem­ic stum­bles. Iskra Reić, who cur­rent­ly serves as ex­ec­u­tive VP for Eu­rope and Cana­da, will lead the di­vi­sion.

“In or­der to op­ti­mise the man­age­ment of our ex­ist­ing port­fo­lio of vac­cines and an­ti­bod­ies for vi­ral res­pi­ra­to­ry in­fec­tions, we are cre­at­ing a ded­i­cat­ed Vac­cines and Im­mune Ther­a­pies Unit that brings to­geth­er R&D, man­u­fac­tur­ing, com­mer­cial and med­ical teams,” the spokesper­son wrote. “The team will be ded­i­cat­ed to our COVID-19 vac­cine, our long-act­ing an­ti­body com­bi­na­tion and our de­vel­op­men­tal vac­cine ad­dress­ing mul­ti­ple vari­ants of con­cern, as well as to our ex­ist­ing port­fo­lio for res­pi­ra­to­ry vi­ral dis­ease.”

The Fi­nan­cial Times first re­port­ed the news Tues­day morn­ing. There like­ly won’t be any sig­nif­i­cant in­vest­ment to go along with the re­or­ga­ni­za­tion, FT re­port­ed, with an­oth­er As­traZeneca of­fi­cial claim­ing CEO Pas­cal So­ri­ot will be able to hone in more on oth­er busi­ness­es like on­col­o­gy.

As­traZeneca start­ed off the Covid-19 vac­cine race as one of the in­dus­try’s lead­ers, part­ner­ing with Ox­ford Uni­ver­si­ty on a shot based on ade­n­ovirus tech­nol­o­gy. The com­pa­ny start­ed its large-scale Phase III around the same time as Pfiz­er/BioN­Tech and Mod­er­na, en­rolling thou­sands of par­tic­i­pants in sum­mer 2020.

But around La­bor Day of that year, As­traZeneca halt­ed that Phase III study glob­al­ly af­ter a par­tic­i­pant de­vel­oped symp­toms thought to re­sem­ble a neu­ro­log­i­cal con­di­tion. The tri­al soon re­sumed out­side the US, but didn’t get the FDA go-ahead for about an­oth­er month af­ter the ini­tial pause.

Then, in March 2021, As­traZeneca drew fire from sci­en­tists af­ter re­veal­ing in­ter­im re­sults from the Phase III, with NI­AID di­rec­tor An­tho­ny Fau­ci crit­i­ciz­ing the com­pa­ny for post­ing “out­dat­ed in­for­ma­tion.” At the time, the lat­est da­ta re­port­ed by As­traZeneca in­clud­ed re­sults on­ly through Feb. 17, 2021, more than a month be­fore send­ing out its press re­lease.

When the com­pa­ny scram­bled to an­nounce the newest da­ta, though, hours lat­er, the ef­fi­ca­cy was vir­tu­al­ly the same.

Around the same time, sev­er­al Eu­ro­pean coun­tries — where the shot had al­ready been au­tho­rized — were halt­ing use of the vac­cine over fears of blood clots. Some coun­tries al­so threat­ened to sue As­traZeneca over vac­cine ship­ment de­lays.

The vac­cine has nev­er­the­less served as the pri­ma­ry Covid-19 shot for large swaths of the globe, in­clud­ing for many places un­able to ac­quire mR­NA shots. As­traZeneca and its part­ner the Serum Serum have shipped over 1.3 bil­lion dos­es.

It’s been a long, bumpy road for As­traZeneca’s Covid-19 R&D, but Tues­day’s re­port is os­ten­si­bly an at­tempt to move past the mis­steps. As­traZeneca’s vac­cine is still not au­tho­rized in the US, how­ev­er, and it’s un­clear if the new di­vi­sion will al­so take on the com­pa­ny’s at­tempts to per­suade the FDA. — Max Gel­man

US opts in­to buy­ing more Mer­ck an­tivi­ral pills

As the race for Covid-19 an­tivi­ral pill treat­ments heats up be­tween Mer­ck and Pfiz­er, the for­mer is try­ing to en­sure it can cap­ture as much of the mar­ket as pos­si­ble be­fore a po­ten­tial au­tho­riza­tion.

Mer­ck an­nounced Tues­day that the US gov­ern­ment had pur­chased an­oth­er 1.4 mil­lion cours­es of mol­nupi­ravir, the in­ves­ti­ga­tion­al pill the com­pa­ny said can cut hos­pi­tal­iza­tion and death from Covid-19 by 50%. In ex­change for the pills, Mer­ck will net rough­ly $1 bil­lion should the EUA come through in the next few weeks.

Mol­nupi­ravir is slat­ed for an ad­comm on Nov. 30 af­ter Mer­ck and its part­ner Ridge­back Bio­ther­a­peu­tics sub­mit­ted their pitch last month.

Frank Clyburn

“In light of the con­tin­ued im­pact of the pan­dem­ic on hun­dreds of thou­sands of peo­ple every day, all of us at Mer­ck are mov­ing with ur­gency and rig­or to bring mol­nupi­ravir, with its com­pelling da­ta show­ing a sig­nif­i­cant re­duc­tion in death and hos­pi­tal­iza­tions, to pa­tients as quick­ly as we can,” Mer­ck pres­i­dent of hu­man health Frank Clyburn said in a state­ment.

With Tues­day’s new op­tions ex­er­cised, the US has now pur­chased more than 3 mil­lion cours­es of the Covid-19 an­tivi­ral, to be ac­quired from au­tho­riza­tion through ear­ly 2022, Mer­ck said. The con­tracts have earned Mer­ck a cool $2.2 bil­lion so far, and there are two mil­lion cours­es avail­able through fur­ther op­tions.

Mer­ck and Ridge­back first an­nounced their pill could re­duce the chance that a new­ly di­ag­nosed Covid-19 pa­tient would be hos­pi­tal­ized or die at the be­gin­ning of Oc­to­ber, claim­ing a po­ten­tial pan­dem­ic break­through. Should it be au­tho­rized, the pill would give doc­tors and hos­pi­tals a new tool — on top of mon­o­clon­al an­ti­bod­ies — to keep at-risk in­di­vid­u­als out of in­ten­sive care.

Though the an­ti­body treat­ments have proved po­tent, they re­quire IV in­fu­sions or in­jec­tions and can prove rel­a­tive­ly in­ac­ces­si­ble in ar­eas with lim­it­ed re­sources.

But soon af­ter Mer­ck’s rev­e­la­tion, Pfiz­er saun­tered in with a pill it claims can re­duce hos­pi­tal­iza­tions and deaths in new Covid-19 pa­tients by 89%. Pfiz­er, which an­nounced the news last Fri­day, added that it hasn’t agreed to any US deal just yet, though it has signed ad­vance agree­ments with sev­er­al oth­er coun­tries.

All eyes will like­ly be on the up­com­ing arms race for a po­ten­tial­ly multi­bil­lion dol­lar mar­ket, and it’s one where Mer­ck may face some added pres­sure. Pfiz­er’s Covid-19 vac­cine was the first ap­proved and has made the com­pa­ny bil­lions, while Mer­ck — the world’s lead­ing vac­cine mak­er pri­or to the pan­dem­ic — struck out in its ear­ly vac­cine at­tempts. — Max Gel­man

In­ovio gets FDA per­mis­sion to start PhI­II vax tri­al

Small biotech In­ovio has been fac­ing sev­er­al road­blocks in the US with its Covid-19 vac­cine can­di­date.

The com­pa­ny’s planned Phase II/III tri­al got put on hold last Sep­tem­ber. Af­ter the FDA signed off on the Phase II seg­ment of the tri­al more than a month lat­er, it left the Phase III por­tion in lim­bo. Then, the DoD scut­tled its fund­ing for the PhI­II por­tion ear­li­er this year.

Now, the biotech fi­nal­ly gets to start the next phase of the tri­al in the US.

In­ovio said via a press re­lease this morn­ing that the FDA grant­ed au­tho­riza­tion to the biotech to start the Phase III seg­ment of a clin­i­cal tri­al for the in­ves­ti­ga­tion­al INO-4800 in the US, by lift­ing the par­tial clin­i­cal hold put on the study near­ly 14 months ago.

This comes three months af­ter Brazil OK’d the Phase III seg­ment of the tri­al.

“To­day’s U.S. an­nounce­ment builds on our in­ten­sive glob­al ef­forts in In­dia, Brazil, Philip­pines, Mex­i­co, Colom­bia, and Thai­land where we have re­ceived au­tho­riza­tions to date,” said CEO Joseph Kim in a state­ment.

In­ovio is part­ner­ing with Ad­vac­cine Bio­phar­ma­ceu­ti­cals, based in Suzhou, Chi­na, to con­duct the Phase III seg­ment of the tri­al in mul­ti­ple coun­tries in the Amer­i­c­as, Asia, and Africa, which will eval­u­ate the ef­fi­ca­cy of the vac­cine in two dos­es, giv­en one month apart. — Paul Schloess­er

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

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.