Covid-19 could throw fi­nal hur­dle in­to Ab­b­Vie and Al­ler­gan’s mas­sive merg­er

You can add Ab­b­Vie and Al­ler­gan’s $63 bil­lion merg­er to the list of plans po­ten­tial­ly dis­rupt­ed by Covid-19.

The Fed­er­al Trade Com­mis­sion said that it may need to of­fer ex­ten­sions on cer­tain cas­es be­cause coro­n­avirus-re­lat­ed dis­rup­tions may make it dif­fi­cult for com­pa­nies to make doc­u­ments and wit­ness­es avail­able, Bloomberg re­port­ed.

That could mean a sud­den road­block just be­fore the fin­ish line for the gi­ant drug­mak­ers, who have been slow-walk­ing their way to a merg­er since they an­nounced one last June. Most re­cent­ly, in ear­ly March, the Eu­ro­pean Union gave the all-clear and — months af­ter the FTC is­sued a rare “sec­ond re­quest” in their re­view of the buy­out — the two com­pa­nies said they had agreed to a time­line with the US agency to fin­ish by the first days of the 2nd quar­ter, i.e. ear­ly April or May.

The new­found mo­men­tum came af­ter Al­ler­gan di­vest­ed brazikum­ab, an IL-23 in­hibitor, back to As­traZeneca. In let­ters to the FTC, unions, con­sumer ad­vo­ca­cy groups and De­mo­c­ra­t­ic sen­a­tors raised an­titrust con­cerns about the drug’s sim­i­lar­i­ty to Ab­b­Vie’s IL-23 in­hibitor Skyrizi. Al­ler­gan’s en­docrine drug Zen­pep was al­so di­vest­ed to Nestlé for sim­i­lar rea­sons.

In a state­ment re­leased yes­ter­day, Ab­b­Vie and Al­ler­gan said they had en­tered in­to a con­sent de­cree with the FTC on the di­vest­ments. The com­pa­nies said they ex­pect­ed to close in May.

Di­vesti­tures of this kind are rou­tine in Big Phar­ma merg­ers. Last year, Cel­gene di­vest­ed Ote­zla for $13.4 bil­lion as part of its buy­out by Bris­tol My­ers. The brazikum­ab sell-off, though, didn’t sat­is­fy many of the unions and con­sumer groups op­pos­ing the deal, who wrote to the FTC in Feb­ru­ary that As­traZeneca was ill-po­si­tioned to bring the drug for­ward and that Ab­b­Vie’s re­bate walls on Skyrizi would lim­it the ri­val drug’s mar­ket po­ten­tial.

This deal would make Ab­b­Vie the fourth largest phar­ma­ceu­ti­cal com­pa­ny in the world.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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Paul Stoffels, Galapagos CEO (Andrew Harnik/AP Images)

CAR-T in, IPF drug out: Gala­pa­gos bails on biotech part­ner­ship amid pipeline re­vamp

It turns out that Paul Stoffels’ new plans for Galapagos don’t just involve buying new things. The Johnson & Johnson R&D vet — and new biotech CEO — is also clearing out the attic.

Galapagos is returning rights to a dual chitinase inhibitor it had licensed back in 2020 from Molecure, a Warsaw, Poland-based small molecule drug developer then known as OncoArendi, for €25 million upfront.

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