Covid-19 roundup: Mer­ck pre­pares new study on their $425M Covid drug; CO­V­AX be­gins roll­out but huge dis­par­i­ties still loom

Mer­ck spent $425 mil­lion to buy out On­coIm­mune in No­vem­ber, pre­sum­ably un­der the be­lief that they could scale up their drug for se­vere Covid-19 and get it through the FDA on the strength of a Phase III tri­al the small­er biotech com­plet­ed in Sep­tem­ber.

The FDA threw a wrench in those plans. The agency told Mer­ck last week that the 203-per­son study wasn’t suf­fi­cient to show the drug was ef­fec­tive. Now, Bloomberg re­ports, Mer­ck is prepar­ing an ad­di­tion­al Phase III study, one that will push re­sults — and any chance of ap­proval — back to the end of the year.

It’s an­oth­er Covid-19 set­back for Mer­ck, a Big Phar­ma long known for elite re­search, par­tic­u­lar­ly in in­fec­tious dis­ease; two years ago, they de­vel­oped the first vac­cine for Ebo­la. The com­pa­ny joined the pan­dem­ic fight late, and the var­i­ous tech­nolo­gies they’ve de­vel­oped have since stum­bled. They axed their two vac­cine pro­grams af­ter dispir­it­ing ear­ly re­sults, and they’ve said lit­tle about an Emory-de­vel­oped oral an­tivi­ral they li­censed and put in Phase III.

The FDA’s de­ci­sion is par­tic­u­lar­ly sur­pris­ing giv­en how the Mer­ck-On­coIm­mune buy­out came about. Bloomberg re­port­ed that Op­er­a­tion Warp Speed chief Mon­cef Slaoui bro­kered the deal af­ter the small biotech said their drug re­duced the risk of res­pi­ra­to­ry fail­ure or death in a Phase III tri­al. HHS then gave Mer­ck a con­tract for $356 mil­lion to sup­ply 100,000 dos­es by June.

“It’s not that the agency wasn’t im­pressed by the da­ta, be­cause they were,” Nicholas Kart­so­nis, Mer­ck’s clin­i­cal in­fec­tious dis­ease chief told Bloomberg. “They just want more of it, and more com­fort that if we’re in­deed go­ing to bring this for­ward, that the da­ta gets repli­cat­ed.”

CO­V­AX be­gins roll­out but huge dis­par­i­ties still loom

CO­V­AX, the WHO and Gates-backed vac­cine-shar­ing pro­gram, has had a rocky start, edged out in the hunt for vac­cines by the wealth­i­est coun­tries in the world. As shots rolled out in the US, the UK, and Eu­rope, CO­V­AX large­ly stood on the side­lines: At the end of Feb­ru­ary, more than 100 of the world’s poor­est coun­tries had yet to re­ceive a sin­gle dose.

The pro­gram, though, is be­gin­ning to set bench­marks. They post­ed their first round of glob­al vac­cine al­lo­ca­tions on Tues­day, sched­ul­ing 237 mil­lion dos­es of the As­traZeneca-Ox­ford vac­cine to ship to 142 na­tions by the end of May. The first ones be­gan on Mon­day, af­ter 600,000 dos­es land­ed in Ghana and 500,000 dos­es in Côte d’Ivoire.

The al­lo­ca­tions still amount to drops in the buck­et com­pared to the roll­out in the US alone, where more than 500 mil­lion dos­es have been se­cured in the same time pe­ri­od. Pres­i­dent Biden said Tues­day that the US would have enough vac­cines for its en­tire el­i­gi­ble adult pop­u­la­tion by May —  a bench­mark most of the world may not hit for years.

In ad­di­tion to shots from As­traZeneca, a com­pa­ny that pri­or­i­tized glob­al scale and ac­cess, CO­V­AX will soon be­gin to see shots from oth­er ma­jor de­vel­op­ers. Just over 1 mil­lion Pfiz­er-BioN­Tech vac­cines are in­clud­ed in the first al­lo­ca­tion and No­vavax, which has yet to be au­tho­rized any­where but re­cent­ly showed its vac­cine was high­ly ef­fec­tive in the UK and mod­er­ate­ly ef­fec­tive in South Africa, has pledged 1.1 bil­lion dos­es.

NIH pulls plug on con­va­les­cent plas­ma in pa­tients

The NIH is singing last rites on con­va­les­cent plas­ma.

More than a year af­ter doc­tors around the coun­try be­gan band­ing to­geth­er to get con­va­les­cent plas­ma off the ground as an emer­gency, stop­gap treat­ment for a new, emer­gency virus — and six months af­ter for­mer Pres­i­dent Trump pushed the FDA au­tho­rize it — the NIH has halt­ed its tri­al in con­va­les­cent plas­ma for mod­er­ate pa­tients af­ter a da­ta safe­ty and mon­i­tor­ing board found it had lit­tle ef­fect.

The study, called C3PO and launched in Au­gust, was one of the best hopes for prov­ing con­va­les­cent plas­ma could be an ef­fec­tive treat­ment for Covid-19. Al­though oth­er stud­ies, in­clud­ing the Mayo Clin­ic’s con­tro­ver­sial ex­pand­ed ac­cess pro­gram, fo­cused on se­vere pa­tients, re­searchers be­lieved it should work bet­ter the ear­li­er it was ad­min­is­tered. Small­er stud­ies from oth­er coun­tries bol­stered that be­lief.

The study had en­rolled 511 out of a planned 900 pa­tients. It showed the ther­a­py was safe but un­like­ly to help the group stud­ied.

The FDA al­ready be­gan to roll back its con­tro­ver­sial EUA for con­va­les­cent plas­ma last month, in the face of new ev­i­dence point­ing to its in­ef­fec­tive­ness in hos­pi­tal­ized pa­tients. They said it would on­ly be used in hos­pi­tal­ized pa­tients with ear­ly-stage dis­ease or an im­paired abil­i­ty to make their own an­ti­bod­ies.

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

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point in late-stage tri­al

After Serum Institute CEO Adar Poonawalla announced last month that the world’s largest vaccine maker stopped producing doses of Covid-19 vaccines back in December, the institute is looking to expand.

The CEO told Reuters Monday that the company is considering establishing its first manufacturing plant in Africa in its next step toward global expansion after successfully mass producing and selling hundreds of millions of Covid-19 vaccine doses out of its India-based facilities.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.