Robert Davis, Merck CEO

FDA au­tho­rizes new Mer­ck Covid-19 pill de­spite sci­en­tist­s' con­cerns on its mech­a­nism of ac­tion

The FDA on Thurs­day au­tho­rized an­oth­er new pill to treat the Omi­cron vari­ant, this time from Mer­ck.

While Pfiz­er’s an­tivi­ral may prove to be more ef­fec­tive, and Mer­ck’s pill has left some sci­en­tists ques­tion­ing the dan­gers be­hind its mech­a­nism of ac­tion, mol­nupi­ravir will be an­oth­er weapon in the ar­ma­men­tar­i­um of Covid-19 treat­ments for the US in a time of need, as two mAb treat­ments from Re­gen­eron and Eli Lil­ly are no longer ef­fec­tive against Omi­cron, and as sup­plies of a third mAb from Vir/Glax­o­SmithK­line are very lim­it­ed.

Sup­plies of the Mer­ck pill will not be as lim­it­ed, as the US may have about 400,000 cours­es of Mer­ck’s pill avail­able in the next few days, and by the end of Jan­u­ary, the US gov­ern­ment ex­pects to have about 3 mil­lion cours­es of Mer­ck’s pill, which is the en­tire or­der that the US made.

The con­cern with Mer­ck’s pill is that it works by in­hibit­ing SARS-CoV-2 repli­ca­tion through vi­ral mu­ta­ge­n­e­sis, and some sci­en­tists have raised se­ri­ous reser­va­tions about that MOA.

The FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee nar­row­ly vot­ed 13-10 last month in fa­vor of the pill’s ben­e­fits out­weigh­ing the risks for adults with­in 5 days of de­vel­op­ing Covid symp­toms.

“Com­mit­tee mem­bers who vot­ed ‘No’ cit­ed the fol­low­ing as rea­sons for con­clud­ing that the over­all ben­e­fit-risk ra­tio was un­fa­vor­able: 1) a high num­ber-need­ed-to-treat com­pared with place­bo, 2) un­clear ef­fi­ca­cy against the Delta vari­ant, 3) po­ten­tial to dri­ve vi­ral mu­ta­tions, and 4) mu­ta­genic­i­ty risks,” ac­cord­ing to a sum­ma­ry of the meet­ing.

Mer­ck has to pro­vide re­ports to the FDA on a month­ly ba­sis sum­ma­riz­ing any find­ings as a re­sult of its mon­i­tor­ing ac­tiv­i­ties of ge­nom­ic data­base(s) for the emer­gence of glob­al vi­ral vari­ants.

As part of Thurs­day’s au­tho­riza­tion, FDA made clear that it should be pro­vid­ed to those “for whom al­ter­na­tive COVID-19 treat­ment op­tions au­tho­rized by FDA are not ac­ces­si­ble or clin­i­cal­ly ap­pro­pri­ate,” mean­ing that if Pfiz­er’s pill is avail­able, that might be a bet­ter op­tion.

“I don’t think you would find any­one who would pre­fer the Mer­ck pill to the Pfiz­er pill, giv­en the da­ta ev­i­dent so far,” Walid Gel­lad, a pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Pitts­burgh, told End­points News pre­vi­ous­ly.

As part of the EUA, the FDA said Mer­ck has to “con­duct a thor­ough in­ves­ti­ga­tion in­to the dif­fer­ences in ef­fi­ca­cy ob­served in the first and sec­ond half” of its piv­otal tri­al. Pan­elists at the ad­comm last month cen­tered their ques­tion­ing on the cause of this drop-off in pre­vent­ing hos­pi­tal­iza­tions and deaths, from 50% to 30% be­tween in­ter­im and fi­nal re­sults. Mer­ck and the FDA of­fered few specifics at the meet­ing on why the ef­fi­ca­cy de­clined.

Un­like the Pfiz­er pill, the FDA al­so warned Thurs­day that mol­nupi­ravir is not rec­om­mend­ed for use dur­ing preg­nan­cy, as based on find­ings from an­i­mal re­pro­duc­tion stud­ies, mol­nupi­ravir may cause fe­tal harm.

Mer­ck must main­tain a preg­nan­cy sur­veil­lance pro­gram to col­lect in­for­ma­tion on in­di­vid­u­als who are ex­posed to mol­nupi­ravir dur­ing preg­nan­cy. FDA al­so said that sex­u­al­ly ac­tive in­di­vid­u­als with part­ners of child­bear­ing po­ten­tial are ad­vised to use con­tra­cep­tion dur­ing mol­nupi­ravir treat­ment and for at least three months af­ter the last dose.

Mol­nupi­ravir is al­so not au­tho­rized for use in pa­tients who are less than 18 years of age, or for use for longer than 5 con­sec­u­tive days. A course of treat­ment is ad­min­is­tered as four 200 mil­ligram cap­sules tak­en oral­ly every 12 hours for five days, for a to­tal of 40 cap­sules.

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.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

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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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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TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.