Bit­ter­ly op­posed old guard at Take­da wages a last-ditch fight to block 'for­eign blood­'s' $62B Shire buy­out

As Take­da CEO Christophe We­ber pulls the strings for di­rec­tor sup­port in the $62 bil­lion ac­qui­si­tion of Shire, a small group of ex-Take­da em­ploy­ees have put down their foot and vowed to block the pro­posed deal.

Com­pris­ing 130 mem­bers, the group holds 1% of the Japan­ese drug­mak­ers’ shares. To sway the fi­nal de­ci­sion, they need a third of share­hold­ers to al­so vote no. Their cur­rent tar­gets are do­mes­tic re­tail in­vestors and over­seas in­sti­tu­tion­al in­vestors who own 25 per­cent and 35 per­cent of Take­da shares re­spec­tive­ly, an anony­mous source told Reuters.

The op­po­si­tion once again crys­tal­lizes ten­sion in­side Take­da be­tween its 237-year Japan­ese her­itage and an in­ter­na­tion­al lead­er­ship — what some has de­scribed as “new for­eign blood pit­ted against the old guard in a Japan­ese com­pa­ny.”

We­ber, a French-born ex­ec hand­picked by his pre­de­ces­sor Ya­suchi­ka Hasegawa, has both sym­bol­ized and cham­pi­oned the glob­al­iza­tion of the Japan­ese com­pa­ny, most no­tably by shift­ing the bulk of its R&D group to the Cam­bridge/Boston hub, a long way away from the com­pa­ny’s Tokyo head­quar­ters. His ap­point­ment back in 2014 was op­posed by what ap­pears to be the same group of share­hold­ers, which (ac­cord­ing to Japan­ese out­let Nikkan Yaky­gyo) counts mem­bers of the found­ing fam­i­ly among its ranks.

Yu­jiro Hara, a de­scen­dant of the found­ing fam­i­ly of a phar­ma com­pa­ny ac­quired by Take­da who led the cam­paign against We­ber’s ap­point­ment, com­ment­ed to the Wall Street Jour­nal in 2014 that Take­da “is not a Japan­ese com­pa­ny any­more.” In ref­er­ence to then-CEO Hasegawa’s de­ci­sion to buy Ny­comed, he said “[m]erg­ing and seek­ing scale is not the on­ly way to glob­al­ize.”

The move is more about draw­ing at­ten­tion to “what an ir­ra­tional deal” the Shire buy­out is — giv­en the fi­nan­cial risk and the fact that Roche is en­croach­ing on Shire’s he­mo­phil­ia fran­chise — than ac­tu­al­ly ef­fect­ing a block, Reuters re­ports.

And they are mak­ing their voic­es loud and clear through a se­ries of protests. At last year’s gen­er­al meet­ing, an ul­ti­mate­ly failed at­tempt to block an ad­di­tion­al ad­vi­so­ry ap­point­ment for Hasegawa gar­nered 30.5% of votes.

Take­da is plan­ning to hold the ex­tra­or­di­nary gen­er­al meet­ing in which share­hold­ers will vote on the ac­qui­si­tion in Q4 of this year.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.