Weeks af­ter start­ing, Am­gen flash­es yel­low light on PhI­II of $400M eczema bet

Am­gen is tak­ing its foot off the ped­al just a few weeks af­ter be­gin­ning a late-stage tri­al of a Ky­owa Kirin drug for which it dished out $400 mil­lion last year in ex­change for ex-Japan rights.

The Cal­i­for­nia phar­ma has paused the Phase III ROCK­ET-IG­NITE study, ac­cord­ing to its Japan­ese part­ner’s lat­est earn­ings re­port Thurs­day. The 52-week, 570-pa­tient tri­al be­gan in June and is ex­pect­ed to col­lect fi­nal pri­ma­ry out­come da­ta in March 2024, ac­cord­ing to a fed­er­al tri­als data­base, which cites the study as ac­tive, but not re­cruit­ing.

The news comes the same morn­ing as Am­gen said it would pay about $4 bil­lion to buy Chemo­Cen­tryx, giv­ing the com­pa­ny ac­cess to the au­toim­mune dis­ease drug Tavneos. Am­gen will dis­close quar­ter­ly earn­ings af­ter the mar­kets close Thurs­day.

No safe­ty or ef­fi­ca­cy is­sues were seen, but Ky­owa re­port­ed that af­ter “ad­di­tion­al dis­cus­sions with reg­u­la­tors and our part­ner, we are amend­ing the stud­ies to im­prove pa­tient con­ve­nience and in­ves­ti­gate a range of dos­es.”

An Am­gen spokesper­son emailed a sim­i­lar­ly word­ed state­ment to End­points News, adding, “We con­tin­ue to re­main ex­cit­ed about the broad po­ten­tial of this pro­gram in atopic der­mati­tis.”

The ran­dom­ized study is look­ing at eval­u­at­ing AMG 451, al­so known as KHK4083 and ro­catin­limab, in adults with mod­er­ate-to-se­vere atopic der­mati­tis. The pact with Ky­owa, which in­cludes po­ten­tial for $850 mil­lion in biobucks, is Am­gen’s for­ay in­to a field dom­i­nat­ed by Re­gen­eron and Sanofi’s Dupix­ent.

Am­gen and Ky­owa’s drug is an an­ti-OX40 an­ti­body. Ky­owa Kirin chief re­search of­fi­cer An­drew McK­night pre­vi­ous­ly told End­points that “OX40 de­liv­ers a sur­vival sig­nal to T cells; it up­reg­u­lates an­ti-apop­tot­ic gene tran­scrip­tion. So you’ve got the sur­vival of the T cells and their dif­fer­en­ti­a­tion in­to mem­o­ry cells. So that’s blocked. And while that’s been blocked we’re al­so de­plet­ing the OX40 pos­i­tive cells in the le­sions of atopic der­mati­tis pa­tients.”

Sanofi is tar­get­ing OX40L with am­lite­limab, which it picked up through the Big Phar­ma’s $1.45 bil­lion buy­out of Kymab in Jan­u­ary 2021. The mon­o­clon­al an­ti­body, al­so known as SAR445229 and pre­vi­ous­ly KY1005, is be­ing stud­ied in Phase II clin­i­cal tri­als in pa­tients with atopic der­mati­tis and adults with mod­er­ate-to-se­vere asth­ma.

The Phase IIb STREAM-AD study out of Sanofi is slat­ed to col­lect fi­nal pri­ma­ry out­come da­ta in June 2023 af­ter kick­ing off in March of this year.

Ed­i­tors’ note: This ar­ti­cle was up­dat­ed to clar­i­fy Am­gen and Ky­owa’s drug tar­gets OX40, not OX40L.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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