Covid-19 roundup: Eli Lil­ly's RA drug gets so­lo OK from FDA; Emer­gent gets green­light to re­sume man­u­fac­tur­ing at Bayview site

The FDA late Wednes­day ex­tend­ed the EUA for Eli Lil­ly’s rheuma­toid arthri­tis drug Olu­mi­ant (baric­i­tinib) to be used as a so­lo treat­ment for Covid-19 in hos­pi­tal­ized adults and pe­di­atric pa­tients who need sup­ple­men­tal oxy­gen.

The oral drug was pre­vi­ous­ly cleared in con­junc­tion with Gilead’s remde­sivir to treat those hos­pi­tal­ized with Covid-19.

In a Phase III study re­port­ed in April, Olu­mi­ant did not meet its pri­ma­ry end­point. The drug failed to reach sta­tis­ti­cal sig­nif­i­cance for the dif­fer­ence in rate of pa­tients need­ing non-in­va­sive or in­va­sive ven­ti­la­tion for the first time, or those who died af­ter 4 weeks. But FDA said that the re­vised EUA for baric­i­tinib was sup­port­ed by da­ta from that study, which showed a re­duc­tion in the pro­por­tion of pa­tients who died af­ter 4 weeks of fol­low-up com­pared to pa­tients treat­ed with the stan­dard of care alone.

In May, Eli Lil­ly ex­pand­ed its drug li­cense with three gener­ic drug­mak­ers out of In­dia, in an ef­fort to curb the coun­try’s sec­ond wave of Covid cas­es. Baric­i­tinib was grant­ed emer­gency use ap­proval in In­dia for the treat­ment of adult pa­tients who need oxy­gen and are hos­pi­tal­ized.

Emer­gent re­sumes man­u­fac­tur­ing at Bayview site

Rough­ly three months af­ter man­u­fac­tur­ing at Emer­gent BioSo­lu­tions’ Bal­ti­more Bayview plant was halt­ed, the FDA has giv­en the com­pa­ny the go-ahead to re­sume pro­duc­tion.

The pro­duc­tion of J&J’s Covid-19 vac­cine will re­sume — af­ter the site shut down fol­low­ing a con­t­a­m­i­na­tion in­ci­dent that re­sult­ed in the dis­card­ing of mil­lions of Covid-19 dos­es. A batch of drug sub­stances in­tend­ed for the As­traZeneca vac­cine came in close prox­im­i­ty with a J&J batch, con­t­a­m­i­nat­ing it.

“The Amer­i­can peo­ple should have high ex­pec­ta­tions of the part­ners its gov­ern­ment choos­es to help pre­pare them for dis­as­ter, and we have even high­er ex­pec­ta­tions of our­selves,” Emer­gent CEO Bob Kramer said in a state­ment. “We have fall­en short of those lofty am­bi­tions over the past few months but re­sump­tion of man­u­fac­tur­ing is a key mile­stone and we are grate­ful for the op­por­tu­ni­ty to help bring this glob­al pan­dem­ic to an end. We’d like to thank our gov­ern­ment part­ners as well as John­son & John­son for their sup­port.”

De­mand for J&J’s sin­gle-dose jab has waned in the US re­cent­ly, but it re­mains a vi­able op­tion for coun­tries over­seas that are lack­ing ad­e­quate dos­es, par­tic­u­lar­ly those try­ing to in­oc­u­late peo­ple in rur­al ar­eas.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

Four community leaders who are living with HIV celebrate life and accomplishments in Theratechnologies' new campaign

Re­al pa­tient ‘cham­pi­ons’ liv­ing with HIV star in Ther­at­e­ch­nolo­gies cam­paign

Over the past several years, people living with HIV have been more often telling Theratechnologies that they wanted more representation. Specifically, they wanted more African American people and more focus on living and thriving versus more typical medication regimen messaging.

So Theratechnologies came up with a new campaign called “I Am A Champion,” initially launched at the US Conference on HIV last year. The initial conference, print and digital media efforts highlight the triumphs of four long-term survivors from across the US.

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