EMA might de­ny Mer­ck­'s mol­nupi­ravir con­di­tion­al mar­ket­ing au­tho­riza­tion — re­port

While Mer­ck’s Covid-19 an­tivi­ral mol­nupi­ravir has been giv­en EUA in the US, it has still been pend­ing au­tho­riza­tion in Eu­rope. And ac­cord­ing to a new re­port from the Fi­nan­cial Times, the EMA might not rec­om­mend grant­i­ng con­di­tion­al mar­ket­ing au­tho­riza­tion — po­ten­tial­ly shut­ting Mer­ck’s an­tivi­ral out of one of the world’s largest drug mar­kets.

Peo­ple fa­mil­iar with the ap­proval process told the news or­ga­ni­za­tion that the EMA is un­like­ly to grant con­di­tion­al mar­ket­ing au­tho­riza­tion to Mer­ck’s Covid-19 an­tivi­ral as it wres­tles with “prob­lem­at­ic” da­ta.

It is “pos­si­ble” that the oral Covid drug mol­nupi­ravir will not re­ceive ap­proval at all, one of the peo­ple said.

Mer­ck’s an­tivi­ral made head­lines last year af­ter a tri­al sug­gest­ed that the an­tivi­ral drug was 50% ef­fec­tive against death and hos­pi­tal­iza­tion from Covid-19. How­ev­er, fur­ther study showed ef­fi­ca­cy to be low­er than that — clos­er to 30%. While the FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee nar­row­ly vot­ed 13-10 back in De­cem­ber in fa­vor of the pill, cit­ing its ben­e­fits out­weigh­ing the risks for adults with­in 5 days of de­vel­op­ing Covid symp­toms, a sum­ma­ry of the meet­ing shows that the com­mit­tee mem­bers who vot­ed “No” against the pill cit­ed the fol­low­ing rea­sons as to why: 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.

The EMA gave the an­tivi­ral a pre­lim­i­nary nod last year af­ter re­view­ing ini­tial da­ta, al­low­ing EU mem­ber states to pre­scribe the drug be­fore mar­ket­ing au­tho­riza­tion was giv­en — some­thing that Mer­ck not­ed in a state­ment to End­points News.

“We be­lieve a range of med­i­cines and vac­cines are need­ed to make an im­pact on the pan­dem­ic and that it’s im­por­tant in med­i­cine to have a se­lec­tion of treat­ments avail­able for var­i­ous pa­tient groups,” Mer­ck said to End­points“We are very con­fi­dent in the clin­i­cal pro­file of mol­nupi­ravir and are mov­ing with rig­or and ur­gency to bring this med­i­cine for­ward to pa­tients around the world.” 

Re­gard­ing the EMA: A Mer­ck spokesper­son said, “We are in ac­tive dis­cus­sions with reg­u­la­tors with aim of bring­ing mol­nupi­ravir to pa­tients in Eu­rope as quick­ly as pos­si­ble.”

And while the FDA re­strict­ed mol­nupi­ravir’s use in pa­tients un­der the age of 18 and pre­vent­ed use for more than 5 con­sec­u­tive days, French reg­u­la­tors de­clined to give mol­nupi­ravir the OK amid ef­fi­ca­cy con­cerns and the po­ten­tial im­pact of the Omi­cron vari­ant. The coun­try lat­er can­celed its or­der.

Mer­ck said on an earn­ings call late last year that it ex­pect­ed $5 bil­lion to $6 bil­lion in sales for the drug in 2022.

A per­son fa­mil­iar with the EMA ap­proval process told the Times that the drug had been “a bit of a dis­ap­point­ment” and that 30% ef­fi­ca­cy “start­ed to be on the lim­its of [what is con­sid­ered] ben­e­fit.” Some US phar­ma­cies have been re­port­ing that they have been run­ning out of space to store the pill — be­cause so few peo­ple are us­ing it.

Rather, peo­ple are be­ing pre­scribed both Pfiz­er’s pill Paxlovid and GSK/Vir’s mon­o­clon­al an­ti­body sotro­vimab for use ahead of mol­nupi­ravir — mak­ing the an­tivi­ral es­sen­tial­ly a third-line treat­ment.

Mer­ck’s share price has re­mained al­most ex­act­ly the same, with $MRK clos­ing at $77.84 yes­ter­day and open­ing this morn­ing at $77.17.

Ac­cord­ing to Eu­ro­pean of­fi­cials, health­care sys­tems in Eu­rope are al­so fa­vor­ing Paxlovid, which has re­port­ed 89% ef­fi­ca­cy in re­duc­ing death and hos­pi­tal­iza­tion.

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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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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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.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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