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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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UCB buys its way to epilep­sy show­down with Jazz with $1.9B Zo­genix ac­qui­si­tion

Zogenix’s epilepsy drug Fintepla may only have brought in around $100 million of sales in its first year, but UCB clearly believes it can go much, much higher.

The Belgian pharma has inked a $1.9 billion deal to buy out Zogenix, paying $26 per share in cash and offering a contingent value right worth $2 more per share if Fintepla lands an extra EU approval by the end of 2023.

But even the upfront marks a 72% premium to California-based Zogenix’s shares, which were trading just north of $15 on Tuesday.

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