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

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.