A last-ditch ef­fort to de­rail Take­da’s $62B Shire buy­out goes down in flames

Backed by se­nior mem­bers of the found­ing fam­i­ly, the tra­di­tion­al­ists among Take­da’s in­vestors have made their last stand in the fight against re­mak­ing the 237-year-old com­pa­ny as a glob­al heavy­weight.

They lost.

Op­po­si­tion was ren­dered fu­tile as a large ma­jor­i­ty of the Japan­ese drug­mak­er’s share­hold­ers ul­ti­mate­ly agreed to sanc­tion the $62 bil­lion takeover of Britain’s rare dis­ease drug spe­cial­ist Shire.

The de­ci­sion came on Wednes­day as part of an ex­tra­or­di­nary gen­er­al meet­ing (EGM) of Take­da share­hold­ers, who were asked to vote on the deal that could ce­ment the biggest-ever ac­qui­si­tion of a Japan­ese com­pa­ny over­seas, and vault the com­bined en­ti­ty to one of the top 10 drug­mak­ers in the world, but al­so one sad­dled with a hefty debt load.

The vote fol­lows the rul­ing of the Eu­ro­pean Com­mis­sion last month to al­low the deal to con­sum­mate on the ba­sis that Take­da will di­vest SHP647 so it can re­tain its block­buster drug En­tyvio to ame­lio­rate an­titrust con­cerns re­lat­ed to the over­lap in in­flam­ma­to­ry bow­el dis­ease treat­ments. The deal was struck in May un­der chief Christophe We­ber — the Japan­ese group’s first non-Japan­ese CEO — and has al­ready won the ap­proval of reg­u­la­tors in Japan, the Unit­ed States, Chi­na and Brazil.

Take­da is fi­nanc­ing the ac­qui­si­tion by is­su­ing new shares and a $30.9 bil­lion bridge loan. The deal is ex­pect­ed to close on Jan­u­ary 8th — smack in the mid­dle of the JPM con­fer­ence.

Take­da, whose rev­enue is shrink­ing as gener­ics eat in­to its busi­ness, has been forced to look else­where to rein­vig­o­rate its growth. Shire is an at­trac­tive propo­si­tion with its ar­se­nal of rare dis­ease drugs, how­ev­er its slate of treat­ments are not im­mune to com­pe­ti­tion ei­ther. Some Take­da share­hold­ers have op­posed the takeover on these grounds, say­ing the com­pa­ny will ul­ti­mate­ly have to in­vest fur­ther in home-grown ex­per­i­men­tal ther­a­pies, or tap in­to oth­er pipelines to stay com­pet­i­tive.

Shire is hold­ing its own share­hold­er meet­ing on Wednes­day.

Im­age: Christophe We­ber. AP IM­AGES

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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