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.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.