Al­ler­gan dou­bles down on NM­DA de­pres­sion drug de­vel­op­ment ef­forts, bag­ging an op­tion to a small mol­e­cule fol­lowup drug

Close to three years af­ter Al­ler­gan $AGN swooped in to buy Nau­rex and its NM­DA drug for de­pres­sion for $560 mil­lion in cash, help­ing spin out the orig­i­nal team in­to a new biotech dubbed Aptinyx, the two have fol­lowed up with an op­tion deal on a small mol­e­cule fol­low-up pro­gram.

Nor­bert Riedel

Al­ler­gan has so far clear­ly en­joyed its late-stage work on ra­pastinel, an IV drug which the FDA des­ig­nat­ed a break­through ther­a­py for ma­jor de­pres­sion. NM­DA has been a tar­get for years in the R&D crowd fo­cused on de­pres­sion, and Aptinyx CEO Nor­bert Riedel has steered a course to prov­ing that his re­searchers found the ther­a­peu­tic strat­e­gy for get­ting it right.

Just last fall Riedel scored a $70 mil­lion round for his spin­out, which put Bain’s Adam Kop­pel on the board.

There’s no im­me­di­ate word on ex­act­ly how much Al­ler­gan is pay­ing for the small mol­e­cule fol­low-up to the IV ther­a­py, which is called AGN-241751.

David Nichol­son, Al­ler­gan

Al­ler­gan’s ef­forts on de­pres­sion come as a va­ri­ety of biotechs are jock­ey­ing for po­si­tion in search of ap­provals. Alk­er­mes $ALKS was ini­tial­ly stiff-armed on its ap­pli­ca­tion af­ter its lead de­pres­sion drug went 1 for 3 in Phase III, un­der­scor­ing just how hard it is to il­lus­trate suc­cess against high place­bo re­spons­es. And J&J $JNJ is hop­ing to score soon with a pitch on es­ke­t­a­mine, its low dose ver­sion of a horse tran­quil­iz­er that is bet­ter known as Spe­cial K on the par­ty scene. Sage $SAGE, mean­while, has man­aged to at­tract con­sid­er­able at­ten­tion for its work on post­par­tum de­pres­sion, de­spite stick­ing with small study pop­u­la­tions.

Al­ler­gan CEO Brent Saun­ders be­lieves he has good odds in this race.

“Ra­pastinel is a great drug that we have at Phase III,” Saun­ders told Jim Cramer a few weeks ago. “We’ll get the da­ta [in the] ear­ly part of next year. It could be an ab­solute game-chang­er for de­pres­sion.”

“Through our pro­duc­tive re­search col­lab­o­ra­tion with Aptinyx and par­al­lel de­vel­op­ment of ra­pastinel, we have gained im­por­tant in­sights in­to NM­DA re­cep­tor mod­u­la­tion as a po­ten­tial ther­a­peu­tic ap­proach for de­pres­sion,” said David Nichol­son, the chief R&D of­fi­cer at Al­ler­gan. “We plan to ad­vance AGN-241751 for the treat­ment of MDD and be­lieve its phar­ma­co­log­i­cal pro­file will en­able it to be­come an oral com­ple­ment to ra­pastinel, fur­ther bol­ster­ing our pipeline of ther­a­peu­tics ad­dress­ing ar­eas of sig­nif­i­cant un­met med­ical need.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

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How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.