With mega merg­er sea­son in full swing, Take­da of­fi­cial­ly swal­lows Shire

Amidst a flur­ry of mul­ti-bil­lion dol­lar merg­ers in 2019, the biggest-ever over­seas ac­qui­si­tion by a Japan­ese drug­mak­er was con­sum­mat­ed on Tues­day, as Take­da closed its $62 bil­lion takeover of rare dis­ease spe­cial­ist Shire.

First dis­cussed in March 2018, the deal that ex­pands Take­da’s foot­print in the world’s biggest mar­ket for drugs — the Unit­ed States — and cre­ates an en­ti­ty with com­bined rev­enues of more than $30 bil­lion was con­clud­ed de­spite an in­ter­nal re­volt by old timers in the Take­da share­hold­er base that cast doubt on the val­ue of the trans­ac­tion con­sid­er­ing the size of the Dublin-based com­pa­ny’s debt.

Christophe We­ber

Take­da — which will keep its pri­ma­ry list­ing on the Tokyo Stock Ex­change, where it has trad­ed since 1949 — pub­licly de­buted un­der the sym­bol $TAK on the NYSE on Christ­mas Eve 2018. It is now one of top 10 phar­ma com­pa­nies in the world, and will like­ly fall one rung low­er in that list, if Bris­tol-My­ers Squibb’s $BMY planned $74 bil­lion takeover of Cel­gene $CELG is re­al­ized.

As pres­sure to sta­bi­lize drug prices heats up, and loom­ing key patent ex­pi­ra­tions wor­ry in­vestors, drug­mak­ers are scram­bling to con­sol­i­date, es­pe­cial­ly as the De­cem­ber rout of the stock mar­ket al­lows for rel­a­tive­ly down-to-earth val­u­a­tions in an in­dus­try that has nor­mal­ized high dou­ble dig­it pre­mi­ums. On Mon­day, days af­ter the Bris­tol-My­ers/Cel­gene an­nounce­ment, Eli Lil­ly $LLY made a $8 bil­lion bet on Loxo On­col­o­gy’s $LOXO ros­ter of can­cer drugs.

For Take­da, its next headache will be in­te­gra­tion. Chief Christophe We­ber has re­port­ed­ly sig­nalled he is plan­ning on mak­ing di­vest­ments in non-core busi­ness­es to re­lieve the hefty debt bur­den, which com­pelled rat­ing agency Moody’s to down­grade the com­pa­ny in De­cem­ber, cit­ing the near­ly six-fold in­crease in debt.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

Bing Li, Debra Yu and Konstantin Poukalov, LianBio

Per­cep­tive births its first in-house start­up — and it's a Chi­na play

Perceptive Advisors is going to China.

The decision dates back two years, chief investment officer Adam Stone tells Endpoints News, when the firm began to figure out how it can, in hedge fund-speak, strategically increase its exposure to a growing biopharma market poised to be a key geographic area in the next several decades. It was a bit of a blindspot for Perceptive, he admits.

As “globalized scientist-investors, we just couldn’t afford to have that blindspot in place,” he says.

Lig­and scoops up Pfenex for up to $516M, adding pro­teins to their an­ti­body chick­ens and de­liv­ery tech

The technology hunting folks over at Ligand Pharmaceuticals have picked up a new one from across town, for a significant price.

Ligand has acquired fellow San Diego-based biotech Pfenex and their protein expression platform for $438 million cash, plus $78 million in contingent value agreements should an undisclosed milestone be hit before the end of next year.  The deal pays $12 per share, or $4.34 more than what Pfenex had been trading at before the announcement.

Ugur Sahin, BioNTech CEO

Covid-19 roundup: Pfiz­er-backed BioN­Tech plans to seek FDA OK for a new vac­cine 'as ear­ly as' Oc­to­ber — ahead of the elec­tion

BioNTech execs say they’re on track to get their late-stage data on a Covid-19 vaccine — partnered with Pfizer — into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they won’t be wasting any time in hustling that over to the FDA.

“I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and co-founder.

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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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