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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

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Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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