Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er ex­pands in­to France; Omi­cron-spe­cif­ic ver­sion of Mod­er­na's boost­er com­ing soon 

As the hype sur­round­ing Pfiz­er’s an­tivi­ral Covid-19 pill swirls, the phar­ma an­nounced that it will build a pro­duc­tion fa­cil­i­ty in France to make the drug as a part of a five-year in­vest­ment.

Pfiz­er will team up with No­vasep to in­stall equip­ment and ini­ti­ate tech trans­fer and on-site de­vel­op­ment at No­vasep’s Mourenx fa­cil­i­ty. The move is a part of a $594 mil­lion in­vest­ment in France.

“We are of course proud to con­tribute to the man­u­fac­tur­ing of this med­i­cine which has shown in clin­i­cal tri­als to have a pos­i­tive im­pact on hos­pi­tal­iza­tion among at-risk Covid-19 pa­tients,” No­vasep’s CEO Michel Spag­nol said in a state­ment. “This con­tract al­so val­i­dates our in­vest­ment strat­e­gy for sev­er­al years and our fo­cus on small mol­e­cules.”

The move comes af­ter France can­celed an or­der for Mer­ck’s an­tivi­ral pill fol­low­ing dis­ap­point­ing test re­sults, and coun­try lead­ers went all in on the Pfiz­er ver­sion of the treat­ment.

Paxlovid was found to re­duce the risk of hos­pi­tal­iza­tion by 89% in tri­al with the same safe­ty pro­file as place­bo, Pfiz­er re­port­ed. At the JP Mor­gan Health­care Con­fer­ence, CEO Al­bert Bourla said that “any de­cent man­u­fac­tur­er” can make the an­tivi­ral, de­spite its com­pli­cat­ed chem­istry that re­quires time to syn­the­size the API.

But as ex­perts have out­lined, a short­age in APIs com­bined with the high vol­ume of pills tak­en in a sin­gle course could com­pli­cate the man­u­fac­tur­ing process.

An­oth­er 40 em­ploy­ees are set to be hired at the Mourenx site as the site ex­pands, and it is ex­pect­ed to help with the sup­ply chain as ear­ly as Q3 of this year. More ex­pan­sion to oth­er No­vasep fa­cil­i­ties is ex­pect­ed in 2023, the com­pa­ny said.

Fu­ture ver­sions of Mod­er­na’s boost­er com­ing soon 

Stéphane Ban­cel

Da­ta from an Omi­cron-spe­cif­ic vac­cine can­di­date from Mod­er­na will be good to go in March, the com­pa­ny’s CEO said at the World Eco­nom­ic Fo­rum’s vir­tu­al Davos Agen­da con­fer­ence.

The shot is be­ing fin­ished right now and should be in the clin­ic in a few weeks, Stéphane Ban­cel said. Mod­er­na’s al­so work­ing on a jab that would com­bine the boost­er dose with a flu shot, but that would not be avail­able un­til the fall of 2023, in a best-case sce­nario.

That shot, Ban­cel says, could serve as a pos­i­tive way to con­vince peo­ple to get a boost­er shot when they are not fond of be­ing jabbed in the arm sev­er­al times a year.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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