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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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