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.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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Roche's headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

Roche ditch­es fi­nal PhI­II for can­cer hope­ful, re­ports set­back for key drug in $1.4B buy­out

Over the past few years, Roche has released news about its AKT inhibitor ipatasertib in drips — most of them negative. The drug yielded mixed data in a key prostate cancer trial, Phase III flops in triple-negative breast cancer forced the pharma giant to pull the plug there, and in mid-2022 Roche trimmed two more early-stage indications in prostate cancer after completing the trials.

Now, the last piece of the program is gone.

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Simba Gill, Evelo Biosciences CEO

Sim­ba Gill stay­ing on at Evelo to weath­er lay­offs and a PhII fail

Simba Gill will be staying put as CEO of Evelo Biosciences for now.

Gill announced last year that he would be leaving the head position at Evelo to take on the role of executive partner at Flagship Pioneering. He was aiming to stay on until a successor was selected, but there’s a new course of action in the wake of a Phase II miss and a reduced headcount.

“I want to emphasize that I remain personally committed to Evelo and staying on to lead the organization. I continue to believe that Evelo is a remarkable opportunity in terms of the science, the platform, the type of products that we’re able to produce, and most importantly, the potential of millions of patients suffering from all stages of inflammatory disease,” Gill said on a conference call.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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