Tim Walbert, Horizon CEO via YouTube

UP­DAT­ED: Hori­zon hits the gas ped­al on re­newed ear­ly-stage R&D, en­list­ing a Mitch Gold biotech in a $1.5B+ deal

Hori­zon Ther­a­peu­tics is no stranger to swing­ing deals, and on Thurs­day the Irish biotech grabbed it­self a new part­ner to help build out its ear­ly-stage pipeline.

In a col­lab­o­ra­tion ex­pect­ed to bring up to four new pro­grams in­to the fold, Hori­zon is team­ing up with Alpine Im­mune Sci­ences in a deal worth po­ten­tial­ly more than $1.5 bil­lion, the com­pa­nies an­nounced Thurs­day morn­ing. Hori­zon will pay $25 mil­lion up­front in cash and make a $15 mil­lion eq­ui­ty in­vest­ment, with promis­es of up to $381 mil­lion mile­stones for each can­di­date.

Once Alpine ad­vances the mol­e­cules to pre-de­fined pre­clin­i­cal mile­stones, Hori­zon will take over all de­vel­op­ment and com­mer­cial­iza­tion costs.

The com­pa­nies aren’t shar­ing much de­tail on the pro­grams them­selves, though they not­ed Hori­zon has al­ready se­lect­ed a lead pre­clin­i­cal can­di­date. A press re­lease not­ed the col­lab­o­ra­tion will “in­clude pre­vi­ous­ly undis­closed mul­ti-spe­cif­ic fu­sion pro­tein-based ther­a­peu­tic can­di­dates for au­toim­mune and in­flam­ma­to­ry dis­eases.”

Andy Paster­nak

Andy Paster­nak, Hori­zon’s chief strat­e­gy of­fi­cer, told End­points News in an in­ter­view that Thurs­day’s deal fits in­to the com­pa­ny’s broad­er plans to beef up its dis­cov­ery and pre­clin­i­cal ef­forts. Alpine’s plat­form cen­ters around the abil­i­ty to hit mul­ti­ple path­ways with a sin­gle mol­e­cule, Paster­nak said, pro­vid­ing the main ap­peal of the part­ner­ship.

“When we com­bine that with our in­sights on the re­search side of tar­gets that we want to pur­sue, as well as ul­ti­mate­ly, our clin­i­cal de­vel­op­ment and com­mer­cial ca­pa­bil­i­ties, we felt that that was a very nice fit,” Paster­nak told End­points.

But Thurs­day’s deal is un­like­ly to be Hori­zon’s last, he added, as Alpine rep­re­sents just “one piece of our re­search strat­e­gy.” Hori­zon will con­tin­ue to be ac­tive on the busi­ness de­vel­op­ment front as well as look­ing for more col­lab­o­ra­tions.

Alpine chief busi­ness of­fi­cer Re­my Du­rand said in an in­ter­view, mean­while, that the deal marks a cap­stone in a great year for the biotech. The plat­form in ques­tion deals with de­vel­op­ing drugs based off na­tive sig­nal­ing pro­teins in the im­mune synapse.

“Our do­mains are much small­er, they’re about half the size of a typ­i­cal an­ti­body,” Du­rand said. “And this al­lows them to in­ter­po­late more ef­fec­tive­ly and ef­fi­cient­ly with­in the im­mune synapse, and to en­gage mul­ti­ple tar­gets in a more nat­ur­al way, as op­posed to go­ing in with a larg­er an­ti­body.”

It’s been a fair­ly busy year for Hori­zon as the com­pa­ny kicked off 2021 with a $3 bil­lion buy­out of As­traZeneca spin­out Viela back in Feb­ru­ary. The deal came with the rare dis­ease drug Up­liz­na, which won ap­proval in the sum­mer of 2020 and could serve as a ri­val to As­traZeneca’s Soliris — ac­quired in the megamerg­er with Alex­ion.

Then in June, Hori­zon dou­bled down on gout in a part­ner­ship with Ar­row­head Phar­ma­ceu­ti­cals that saw the Irish biotech shell out $40 mil­lion up­front. Hori­zon has about $660 mil­lion in mile­stones promised in this deal, fo­cus­ing on the pro­gram known as ARO-XDH, an in­ves­ti­ga­tion­al RNAi ther­a­py for un­con­trolled gout.

The com­pa­ny is al­so dab­bling in man­u­fac­tur­ing, buy­ing out an Irish plant for $65 mil­lion in Ju­ly. Hori­zon plans to uti­lize the fa­cil­i­ty for its fill­ing line and freeze dry­er that can be used for its com­mer­cial med­i­cines Te­pez­za, Up­liz­na and Krys­texxa, as well as for drug de­vel­op­ment.

For Alpine, the biotech has a cou­ple of in-house pipeline pro­grams in ad­di­tion to part­ner­ships with Ab­b­Vie in lu­pus and Adap­ti­m­mune for cell ther­a­pies. Alpine is like­ly hop­ing this deal doesn’t go the way of an­oth­er pre­vi­ous part­ner­ship with Gilead’s Kite, how­ev­er, in which the big biotech called off a col­lab­o­ra­tive ef­fort on CAR-Ts and TCRs.

This ar­ti­cle has been up­dat­ed to in­clude com­ment from Alpine chief busi­ness of­fi­cer Re­my Du­rand.

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.

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.

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.

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.”

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.

HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.