Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

As­traZeneca's planned takeover of Alex­ion clears last reg­u­la­to­ry re­view, deal to close next week

The fi­nal reg­u­la­to­ry hur­dle for As­traZeneca’s mega-merg­er with Alex­ion Phar­ma­ceu­ti­cals has been cleared, paving the way for the deal to close as soon as next week.

Britain’s fi­nan­cial watch­dog, The UK Com­pe­ti­tion & Mar­kets Au­thor­i­ty, has rub­ber stamped As­traZeneca’s $39 bil­lion takeover of the Boston-based rare dis­ease biotech, the com­pa­nies an­nounced Wednes­day morn­ing. As a re­sult, the trans­ac­tion is ex­pect­ed to close on Ju­ly 21, with Alex­ion shares $ALXN be­ing con­vert­ed to As­traZeneca stock $AZN and re­moved from Nas­daq the next day.

Shares will al­so be ad­mit­ted to the Lon­don Stock Ex­change and Nas­daq Stock­holm, the two mar­kets of As­traZeneca’s home coun­tries of the UK and Swe­den. Once the merg­er is wrapped up, Alex­ion will es­sen­tial­ly be­come As­traZeneca’s en­tire rare dis­ease unit with block­buster Soliris and fol­low-up drug Ul­tomiris com­ing on board.

Marc Dunoy­er

“We are very pleased to have se­cured this crit­i­cal fi­nal clear­ance,” As­traZeneca CFO Marc Dunoy­er said in a state­ment. “We look for­ward to the im­mi­nent clos­ing of the trans­ac­tion so that we may pur­sue our shared am­bi­tion to bring more in­no­v­a­tive med­i­cines to pa­tients world­wide and be­gin As­traZeneca’s next chap­ter of growth.”

While ques­tions sur­round­ed the merg­er back when it was an­nounced in De­cem­ber 2020, CEO Pas­cal So­ri­ot has out­lined a vi­sion for As­traZeneca to pave a new path in rare dis­eases for the first half of the next decade. With a par­tic­u­lar fo­cus on im­munol­o­gy, he’s said he ex­pects Alex­ion to help dri­ve growth in the field to the tune of dou­ble dig­it rev­enue through 2025.

The rosy pro­jec­tions still have to per­form, how­ev­er, and many are like­ly to scru­ti­nize the pipeline As­traZeneca is ac­quir­ing in the deal. An­dexxa, one of Alex­ion’s ap­proved med­i­cines to treat acute­ly un­con­trolled bleed­ing of Fac­tor Xa in­hibitors, re­turned dis­ap­point­ing sales num­bers and proved piv­otal in mount­ing ac­tivist pres­sure on CEO Lud­wig Hantson in 2020.

Lud­wig Hantson

Dunoy­er, who will lead the new Alex­ion sub­sidiary when the deal is com­plete, told End­points News in an in­ter­view last month that As­traZeneca doesn’t plan to auc­tion off An­dexxa, and in­stead hopes to turn it around in a sim­i­lar fash­ion to the drug­mak­er’s Bril­in­ta drug.

Of course, it does help that As­traZeneca will im­me­di­ate­ly ben­e­fit from Soliris, which raked in more than $4 bil­lion in sales in 2020, as well as Ul­tomiris, the planned suc­ces­sor for Soliris. Alex­ion has po­si­tioned Ul­tomiris to soak up most of the sales from the old­er drug once it hits its patent cliff lat­er this decade, de­spite some new com­pe­ti­tion.

Wednes­day’s green­light from the UK was large­ly ex­pect­ed fol­low­ing the FTC sign­ing off on the deal in April and the EU sig­nal­ing its ap­proval last week. The FTC re­view came de­spite Pres­i­dent Joe Biden’s ad­min­is­tra­tion say­ing it would take a harsh­er stance on Big Phar­ma merg­ers in March, but none of the feared an­titrust mea­sures came to pass.

One rea­son may have been the lack of a pipeline over­lap be­tween the two com­pa­nies, ac­cord­ing to an analy­sis from Eval­u­ate Phar­ma at the time. None of the com­pa­nies’ mar­ket­ed drugs have any crossover in in­di­ca­tions, and the on­ly pipeline can­di­date that could be seen as sim­i­lar is Alex­ion’s cer­du­la­tinib — a po­ten­tial in­ter­sec­tion with As­traZeneca’s blood can­cer fran­chise.

And while the Alex­ion deal had been viewed by some as a po­ten­tial bell­wether for the in­dus­try, the FTC has been harsh­er on oth­er com­pa­nies so far this year. The com­mis­sion has sued to block Il­lu­mi­na’s $8 bil­lion buy­out of Grail, ex­press­ing con­cerns over Il­lu­mi­na’s po­ten­tial stran­gle­hold on the DNA se­quenc­ing mar­ket.

The Il­lu­mi­na merg­er is run­ning up against new head­winds as well, with the EU ex­pect­ed to launch a full-scale an­titrust probe at the end of its re­view next week, Reuters re­port­ed Tues­day.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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