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.”

 

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

Covid-19 roundup: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

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President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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