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.”

 

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Af­ter 4 years of furor, the FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. And this time they plan to squash it

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition.

J&J's Spra­va­to gets no love from NICE, jeop­ar­diz­ing its prospects in the UK

UK’s cost-effectiveness watchdog NICE is taking the same track laid out by ICER — J&J’s pharmaceutical version of the hallucinogenic anesthetic ketamine, Spravato, is low value for money. On Tuesday, the agency refused to endorse the therapy for inclusion as a reimbursable drug on the the UK’s National Health System.

Cognizant of the myriad of approved antidepressants that often don’t work, EU regulators endorsed J&J’s low-dose, nasal-spray formulation of ketamine last month for treatment-resistant depression.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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UP­DAT­ED: Ac­celeron of­fers thumbs up on a PhII suc­cess for would-be block­buster drug — and shares rock­et up

There’s no public data yet, but Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.