Back to the im­munol­o­gy draw­ing board, Ab­b­Vie inks dis­cov­ery deal with old Al­ler­gan part­ner

Al­ler­gan’s neu­rol­o­gy-fo­cused R&D pact with So­sei Hep­tares hasn’t been all ros­es, but the BD team at Ab­b­Vie found enough to like about the G pro­tein-cou­pled re­cep­tor spe­cial­ist’s dis­cov­ery en­gine to kick off a new col­lab­o­ra­tion. The goal? Find­ing small mol­e­cules tar­get­ing in­flam­ma­to­ry and au­toim­mune dis­eases.

Mal­colm Weir

The part­ner­ship starts small, with $32 mil­lion in up­front and near-term mile­stones plus po­ten­tial op­tion, de­vel­op­ment and com­mer­cial pay­ments of up to $377 mil­lion. But if Ab­b­Vie choos­es to ex­e­cute on all four tar­gets, the to­tal deal val­ue could grow to a size “in a sim­i­lar ball­park” to the bil­lion-dol­lar pacts with Genen­tech and Take­da, a So­sei spokesper­son told Reuters.

“Col­lab­o­rat­ing with lead­ing phar­ma­ceu­ti­cal com­pa­nies is a core el­e­ment of our suc­cess­ful val­ue-gen­er­at­ing strat­e­gy,” Mal­colm Weir, ex­ec­u­tive vice chair­man of So­sei Hep­tares, said in a state­ment.

The biotech brings its GPCR-sta­bi­liz­ing tech to the ta­ble, which al­lows for eas­i­er pro­cess­ing and screen­ing as sci­en­tists pur­sue struc­ture-based drug dis­cov­ery.

Lisa Ol­son

Lisa Ol­son, the VP for dis­cov­ery im­munol­o­gy at Ab­b­Vie, called it an ex­ten­sion of the phar­ma gi­ant’s years-long pur­suit for cut­ting-edge tech to push the en­ve­lope for au­toim­mune dis­eases.

Aside from this new re­la­tion­ship, Ab­b­Vie has in­her­it­ed an R&D pro­gram first in­tro­duced by Al­ler­gan in 2016 be­fore the two be­came one in a $63 bil­lion megamerg­er in mid-2019. So­sei Hep­tares got $125 mil­lion up­front in that deal in ex­change for a slate of sub­type-se­lec­tive mus­carinic re­cep­tor ag­o­nists. There was al­so a $50 mil­lion com­mit­ment to­ward Phase II stud­ies in ad­di­tion to over $3 bil­lion in promised mile­stones.

One of the key drugs in that deal, a mus­carinic M1 re­cep­tor ag­o­nist dubbed HTL0018318, was abrupt­ly yanked from an Alzheimer’s tri­al fol­low­ing an “un­ex­pect­ed tox­i­col­o­gy find­ing” from a non-hu­man pri­mate tri­al. So­sei Hep­tares and Al­ler­gan have since moved on­to test­ing the drug in de­men­tia with Lewy bod­ies, al­though it no longer seems to be in Ab­b­Vie’s pipeline.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Pfizer via Youtube)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Scripps reach­es $10M set­tle­ment with gov­ern­ment over al­le­ga­tions NIH grants weren't prop­er­ly ac­count­ed for

Scripps Research Institute has settled a case with the Justice Department alleging claims of misappropriated funds, the US attorney for the district of Maryland announced late last week.

Prosecutors said the institute improperly used NIH-funded research grants for non-grant related activities, including working on new grant applications, teaching activities and other administrative tasks. As part of the settlement, Scripps has agreed to pay $10 million.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.