Ab­b­Vie do­nates $1M+ of the HIV drug that Chi­na is now rec­om­mend­ing for coro­n­avirus treat­ment

Ab­b­Vie is do­nat­ing more than $1 mil­lion worth of an HIV drug to help com­bat the fast-spread­ing coro­n­avirus out­break in Chi­na, the com­pa­ny an­nounced on Fri­day.

Chi­na’s Na­tion­al Health Com­mis­sion has sug­gest­ed Alu­via, a pill con­tain­ing lopinavir and ri­ton­avir, as one of two pos­si­ble treat­ments for the symp­toms of the virus cur­rent­ly known as 2019-nCoV in the ab­sence of ef­fec­tive an­tivi­ral med­ica­tions. The oth­er part is neb­u­lized al­pha-in­ter­fer­on.

A crop of drug­mak­ers — now in­clud­ing J&J — is rac­ing to add more po­ten­tial weapons to the ar­se­nal.

Gov­ern­ment of­fi­cials are rush­ing to con­tain and find so­lu­tions for an epi­dem­ic that orig­i­nat­ed in the in­land city of Wuhan, Hubei but has since popped up in every oth­er re­gion ex­cept for Ti­bet. The Alu­via reg­i­men — two pills per round, twice dai­ly — was in­clud­ed in the third test ver­sion of the “di­ag­no­sis and treat­ment plan for new coro­n­avirus in­fec­tions.”

Guang­fa Wang, a Bei­jing-based pul­monary ex­pert who con­tract­ed the virus af­ter vis­it­ing Wuhan for an in­ves­ti­ga­tion, told Chi­na’s Time-Week­ly that he took Alu­via as part of his treat­ment and it ap­peared to be ef­fec­tive in his case. Shang­hai of­fi­cials said they have adopt­ed this type of HIV drugs since their first pa­tient.

“So far it seems to have cer­tain ef­fects, but we need more clin­i­cal ob­ser­va­tion,” said Hongzhou Lu of the Shang­hai Pub­lic Health Clin­i­cal Cen­ter.

The the­o­ry, yet to be proven, is that Alu­via works by block­ing a pro­tease that the coro­n­avirus needs for re­pro­duc­tion in the hu­man body. Though it’s not the same pro­tease that the drug was orig­i­nal­ly de­signed to block, it might be sim­i­lar enough to de­lay dis­ease pro­gres­sion. Be­cause of that, Alu­via had pre­vi­ous­ly al­so been test­ed in pa­tients with SARS and MERS.

An anony­mous Wuhan doc­tor in­ter­viewed by Time-Week­ly said that Alu­via is use­ful against the nov­el coro­n­avirus, but it’s “hard to come by.”

Ab­b­Vie said on WeChat that it will do­nate RMB$10 mil­lion (around $1.44 mil­lion) worth of pills in re­sponse to the guid­ance, though it didn’t spec­i­fy how it would dis­trib­ute across the coun­try.

Oth­er drug­mak­ers are al­so rush­ing to the call for ef­fec­tive med­ica­tions. Gilead dust­ed off remde­sivir, an an­tivi­ral that missed the mark on Ebo­la, to see about its po­ten­tial against the new virus. Mod­er­na is al­lied with the NIH to de­vel­op a vac­cine while George Scan­gos’ Vir has brought out an­ti­bod­ies. A raft of small-cap biotechs trig­gered a stock ral­ly over po­ten­tial vac­cine can­di­dates that might take years, if ever, to ma­te­ri­al­ize.

On Mon­day J&J threw its name in the hat, as CSO Paul Stof­fels told CN­BC about its ef­forts to cre­ate a po­ten­tial vac­cine, test­ing at least five dif­fer­ent con­structs in par­al­lel and at the same time build­ing an an­i­mal mod­el and prepar­ing the man­u­fac­tur­ing in­fra­struc­ture.

“We are com­fort­able that can cre­ate a vac­cine and scale it up,” he said on air.

Treat­ments are ur­gent­ly need­ed as the death toll in Chi­na ris­es to 81, five of them out­side Hubei province, with al­most 3,000 con­firmed cas­es and dou­ble that num­ber of sus­pect­ed cas­es even as sev­er­al cities are on lock­down. So far, five 2019-nCoV cas­es have been de­tect­ed in the US.

So­cial im­age: Ab­b­Vie

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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