Eu­ro­pean reg­u­la­tors rec­om­mend re­jec­tion of Mer­ck’s Covid-19 drug mol­nupi­ravir

Eu­ro­pean reg­u­la­tors rec­om­mend­ed the EMA re­ject Mer­ck’s Covid an­tivi­ral, say­ing that there’s not enough ev­i­dence it works in pa­tients.

Mer­ck and part­ner Ridge­back Bio­ther­a­peu­tics an­nounced the CHMP’s de­ci­sion on Fri­day.

The com­mit­tee re­fused to rec­om­mend the ap­proval of Lagevrio, al­so known as mol­nupi­ravir, by ini­tial­ly stat­ing that the re­view has been on­go­ing for more than a year. The com­mit­tee had sup­port­ed de­ci­sions from mem­ber states start­ing in No­vem­ber 2021, if they want­ed to con­sid­er ear­ly use of mol­nupi­ravir be­fore any po­ten­tial ap­proval.

Since then, the com­mit­tee said that mol­nupi­ravir’s clin­i­cal ben­e­fit in adults with Covid-19 who are not on sup­ple­men­tal oxy­gen and at in­creased risk of de­vel­op­ing se­vere Covid-19 “could not be demon­strat­ed.” The CHMP said Mer­ck sub­mit­ted re­sults of a study in­ves­ti­gat­ing the an­tivi­ral in more than 1,400 non-hos­pi­tal­ized and un­vac­ci­nat­ed adults with “at least one un­der­ly­ing con­di­tion putting them at risk of se­vere Covid-19.”

CHMP added:

Based on the to­tal­i­ty of da­ta, it was not pos­si­ble to con­clude that Lagevrio can re­duce the risk of hos­pi­tal­i­sa­tion or death or short­en the du­ra­tion of ill­ness or time to re­cov­ery in adults at risk of se­vere dis­ease. Fur­ther­more, it was not pos­si­ble to iden­ti­fy a spe­cif­ic group of pa­tients in whom a clin­i­cal­ly rel­e­vant ben­e­fit of Lagevrio could be demon­strat­ed.

In a state­ment to End­points News, Mer­ck said it be­lieves “the CHMP’s rec­om­men­da­tion does not re­flect the com­pelling da­ta” from its Phase III MOVe-OUT tri­al, the one that Mer­ck used to ob­tain FDA emer­gency use au­tho­riza­tion back in 2021. Mer­ck added that it and Ridge­back are go­ing to ap­peal the de­ci­sion and re­quest a re-ex­am­i­na­tion of the CHMP’s opin­ion.

This is the newest twist for mol­nupi­ravir af­ter the FDA axed the re­quire­ment that pa­tients test pos­i­tive for Covid-19 in or­der to be pre­scribed ei­ther Lagevrio or Paxlovid ear­li­er this month. The FDA has not been Lagevrio’s biggest sup­port­er, af­ter an FDA ad­comm vot­ed 13-10 to ap­prove emer­gency au­tho­riza­tion in 2021, de­spite con­cerns of the drug’s mech­a­nism of ac­tion — and on­ly show­ing 30% ef­fec­tive­ness in pre­vent­ing hos­pi­tal­iza­tions and deaths, down from 50% in an in­ter­im analy­sis.

FDA al­so said last sum­mer that it would not al­low Lagevrio to be pre­scribed by state-li­censed phar­ma­cists — even while al­low­ing those same phar­ma­cists to pre­scribe Paxlovid.

De­spite the rec­om­men­da­tion for Lagevrio, the com­mit­tee post­ed a hand­ful of pos­i­tive de­ci­sions from its month­ly meet­ing this week. Those in­clude In­cyte’s non-seg­men­tal vi­tili­go treat­ment Opzelu­ra and an ex­ten­sion for Re­gen­eron’s Lib­tayo — this time com­boed with chemother­a­py for PD-L1 pos­i­tive NSCLC. An­oth­er pos­i­tive rec­om­men­da­tion went to Ital­ian phar­ma Chiesi and part­ner Pro­tal­ix Bio­Ther­a­peu­tics’ can­di­date PRX-102, al­so known as Elfab­rio, to treat Fab­ry dis­ease.

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.

Luke Miels, GSK chief commercial officer

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

Editor’s note: This is a live story and will be updated.

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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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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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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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.