Shire shares rock­et up af­ter Take­da says it's pon­der­ing a takeover bid

Take­da said ear­ly Wednes­day that it is con­sid­er­ing mak­ing an of­fer to buy Shire $SH­PG, and it has a clear­ly thought out a set of rea­sons why.

As of now, Take­da said in a state­ment that it has made no for­mal of­fer for Shire, but is ex­plor­ing the pos­si­bil­i­ty. That’s ex­act­ly in line with takeover rules to sat­is­fy UK reg­u­la­tors. And Shire’s shares im­me­di­ate­ly blast­ed up­ward, jump­ing 17%. The com­pa­ny start­ed the day with a mar­ket cap of $38 bil­lion.

Christophe We­ber

For Take­da CEO Christophe We­ber, a Shire ac­qui­si­tion would dri­ve a big ex­pan­sion in the Boston area, where the Japan­ese com­pa­ny has been con­cen­trat­ing much of its R&D op­er­a­tions. R&D chief Andy Plump is based in the Boston area, and Shire has been ready­ing new fa­cil­i­ties for it­self in Cam­bridge, near its main in­ter­na­tion­al head­quar­ters in Lex­ing­ton, MA.

A buy­out would al­so come af­ter Take­da had shak­en up its R&D struc­ture glob­al­ly, cut­ting back on staff while do­ing more deals with part­ners like De­nali.

In a state­ment out this morn­ing, Take­da spelled out why it’s prep­ping a bid. A deal, the com­pa­ny said, would:

  • strength­en Take­da’s core ther­a­peu­tic ar­eas of on­col­o­gy, GI and neu­ro­science
  • ac­cel­er­ate Take­da’s vi­sion to be a leader in spe­cial­ized med­i­cines that are trans­for­ma­tive to pa­tients through the ad­di­tion of Shire’s lead­ing glob­al rare dis­ease fran­chise
  • fur­ther en­hance Take­da’s ro­bust R&D strat­e­gy, con­cen­trat­ing on key ther­a­peu­tic ar­eas
  • re­in­force a strong and large-mol­e­cule fo­cused late-stage pipeline with­in Take­da’s core ther­a­peu­tic ar­eas to com­ple­ment Take­da’s own pipeline and dis­cov­ery ca­pa­bil­i­ties
  • bal­ance Take­da’s ge­o­graph­ic fo­cus to align with the mar­ket op­por­tu­ni­ty in the US
  • dri­ve fi­nan­cial val­ue from a strong com­bined fi­nan­cial pro­file
Flem­ming Orn­skov

Shire is still in the midst of a com­plete makeover of its own en­gi­neered by CEO Flem­ming Orn­skov, who has steered the com­pa­ny in­to the rare dis­ease busi­ness while con­sid­er­ing op­tions for pos­si­bly spin­ning out its AD­HD di­vi­sion. Orn­skov lined up  the $32 bil­lion buy­out of Bax­al­ta, but an­a­lysts have been skep­ti­cal about Shire’s fu­ture in light of the big changes it faces as Roche rolls out Hem­li­bra, grab­bing mar­ket share in the he­mo­phil­ia mar­ket.

Shire has fre­quent­ly been raised as a po­ten­tial takeover tar­get, and came close to merg­ing in­to Ab­b­Vie four years ago. That deal fell through with the in­tro­duc­tion of new rules mak­ing cap­i­tal in­ver­sions dif­fi­cult, pre­vent­ing the tax ben­e­fits Ab­b­Vie sought in buy­ing a com­pa­ny which is of­fi­cial­ly based in Ire­land. But the com­pa­ny re­mained a fre­quent­ly cit­ed takeover tar­get, most re­cent­ly at the end of last year, with an­a­lysts won­der­ing if Pfiz­er would make a move.

Now you can ex­pect plen­ty of spec­u­la­tion to fol­low, as an­a­lysts won­der aloud whether Pfiz­er and oth­er po­ten­tial bid­ders will step up to make this an auc­tion.

By the rule book, Take­da now has un­til 5 pm (Lon­don time) on April 25th to make a bid.

Not every­one would con­clude that a buy­out is a good idea.

“While it is im­pos­si­ble to say nev­er on M&A, Shire does not strike us as an ob­vi­ous takeover can­di­date,” said UBS at the time, ac­cord­ing to a re­port from the Fi­nan­cial Times. “Shire’s spe­cial­ty fo­cus and mix of ther­a­peu­tic fo­ci means that most buy­ers would strug­gle to ex­tract sub­stan­tial op­er­a­tional syn­er­gies while es­cap­ing from com­pe­ti­tion prob­lems, in our view. Shire is based in Ire­land, which means a very low cor­po­rate tax rate, which would most prob­a­bly rise in most sce­nar­ios were the com­pa­ny ac­quired. It would al­so be a bold ac­qui­si­tion in our view giv­en the un­cer­tain tra­jec­to­ry of Shire’s haemophil­ia busi­ness.”

 

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

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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.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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

Up­dat­ed: 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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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.

Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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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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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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