Ef­fi­ca­cy of Pfiz­er's Covid pill holds up in fi­nal analy­sis, re­duc­ing risk of hos­pi­tal­iza­tion or death by al­most 90%

The dras­tic dif­fer­ence in ef­fi­ca­cy for Mer­ck’s Covid-19 pill be­tween in­ter­im and fi­nal analy­ses — from a 50% rel­a­tive re­duc­tion in hos­pi­tal­iza­tions and deaths at the in­ter­im to just 30% in the fi­nal re­sults — had some wor­ry­ing that the Pfiz­er pill’s ear­ly suc­cess for adults at high risk of hos­pi­tal­iza­tion might al­so be more mut­ed in the fi­nal re­sults.

But that wasn’t the case ear­ly Tues­day as Pfiz­er said that fi­nal da­ta avail­able from the more than 2,200 high-risk pa­tients en­rolled in its tri­al con­firmed pri­or re­sults show­ing Paxlovid re­duced the risk of hos­pi­tal­iza­tion or death by 89% (with­in three days of symp­tom on­set) and 88% (with­in five days of symp­tom on­set) com­pared to place­bo. The com­pa­ny added:

0.7% of pa­tients who re­ceived PAXLOVID were hos­pi­tal­ized through Day 28 fol­low­ing ran­dom­iza­tion (5/697 hos­pi­tal­ized with no deaths), com­pared to 6.5% of pa­tients who re­ceived place­bo and were hos­pi­tal­ized or died (44/682 hos­pi­tal­ized with 9 sub­se­quent deaths). The sta­tis­ti­cal sig­nif­i­cance of these re­sults was high (p<0.0001).

The da­ta have al­ready been shared with the FDA as part of an on­go­ing rolling EUA sub­mis­sion, Pfiz­er said.

And the FDA may act soon on Pfiz­er and Mer­ck’s pills, both of which need to be tak­en over five days, and both of which seem to hold up against the Omi­cron vari­ant.

But there may be cer­tain re­stric­tions on who should ac­cess the pills, and some lin­ger­ing con­cerns on the Mer­ck pill’s mech­a­nism of ac­tion. For in­stance, the FDA is un­like­ly to au­tho­rize Mer­ck’s pill in preg­nant women, due to the po­ten­tial for fe­tal tox­i­c­i­ties, or those who have been vac­ci­nat­ed be­cause they were not in­clud­ed in the piv­otal tri­al.

And the Mer­ck pill’s MOA, which dri­ves the mu­ta­ge­n­e­sis of the SARS-COV-2 virus to kill it off, could the­o­ret­i­cal­ly in­crease the like­li­hood of vari­ants as a re­sult of wide­spread treat­ment. But so far those fears are the­o­ret­i­cal, and Mer­ck nar­row­ly won the back­ing of an ad­comm for its EUA about two weeks ago.

Once the pills are au­tho­rized by the FDA, sup­plies should be dis­trib­uted short­ly there­after. The US last month paid $5.29 bil­lion for 10 mil­lion cours­es of the Pfiz­er pill, and for Mer­ck’s pill, the US has now pur­chased more than 3 mil­lion cours­es for about $2.2 bil­lion so far.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.