Whisky, se­crets, and code names: be­hind-the-scenes of Takeda's $62B Shire bid - Bloomberg

As it turned out, the March 28 state­ment that launched Take­da’s his­toric $62 bil­lion bid for Shire shook Take­da ex­ecs as much as it did the rest of the bio­phar­ma in­dus­try.

Christophe We­ber

The Japan­ese drug­mak­er had as­sem­bled a se­cre­tive team to work on the deal, with plans to ap­proach Shire’s board by April 1, go­ing so far as to giv­ing the com­pa­nies code names in the fash­ion of Japan­ese whisky brands. Un­named in­sid­ers told Bloomberg that Take­da was dubbed Ya­maza­ki, the na­tion’s No. 1 sin­gle malt, while Shire was com­pared to a “se­duc­tive, blos­som­ing and enig­mat­ic” blend called Hi­bi­ki.

But when ru­mors emerged, the UK takeover pan­el called on Take­da to con­firm its in­ten­tions, forc­ing it to ini­ti­ate what would be­come the biggest M&A deal of the year a few days ear­li­er than it had in­tend­ed to make an of­fer.

So it did, and made sure to apol­o­gize to a sur­prised Shire.

Su­san Kils­by

Weeks of ne­go­ti­a­tions en­sued, with Take­da CEO Christophe We­ber and Shire chair­woman Su­san Kils­by lead­ing the talks in which Shire’s Flem­ming Orn­skov al­so played a key role. We­ber came pre­pared, hav­ing be­gun ex­am­in­ing Shire’s as­sets more than two years pri­or. He and his team had orig­i­nal­ly con­sid­ered just pur­chas­ing Shire’s neu­ro­science unit, a po­ten­tial spin­off sport­ing a price tag $10 bil­lion to $15 bil­lion, but de­cid­ed last fall that ac­quir­ing all of Shire would di­ver­si­fy its port­fo­lio more. A team of bankers from Ever­core, JP­Mor­gan Chase and No­mu­ra Hold­ings fa­mil­iar with the Dublin, Ire­land-based com­pa­ny were brought in to help.

Flem­ming Orn­skov

For­tu­nate­ly for Take­da, a bid­ding war did not erupt as Shire in­vestors had hoped af­ter Al­ler­gan said it might jump in for the ac­tion. That thought last­ed all but a few hours, leav­ing Take­da plough­ing away at four suc­ces­sive of­fers — and seal­ing the deal on the dead­line of May 8.

But there is lit­tle time for We­ber to cel­e­brate Take­da’s en­try in­to the list of top 10 glob­al phar­ma com­pa­nies. We­ber will now have to sell the deal to share­hold­ers while his CSO Andy Plump at­tempts to cut $600M in R&D costs, while vow­ing to stay away from slash-and-burn tac­tics.

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.