No­vo Nordisk tries to tack­le Abl­ynx and bring it in­to the fold with a $3B buy­out of­fer, but the biotech keeps say­ing no

Play­ing a hot hand with a promis­ing late-stage as­set and a new­ly com­plet­ed $200 mil­lion IPO, Abl­ynx has waved away two bids by No­vo Nordisk to ac­quire the com­pa­ny for a hefty pre­mi­um with a bid of up to $3.1 bil­lion.

But No­vo isn’t tak­ing no for an an­swer.

Lars Fruer­gaard Jør­gensen

The Dan­ish bio­phar­ma com­pa­ny says it’s go­ing pub­lic with its of­fer in an at­tempt to put pres­sure on the biotech to start some se­ri­ous ne­go­ti­a­tions. And No­vo says it’s not just in­ter­est­ed in capla­cizum­ab, which is be­ing de­vel­oped for an ul­tra rare blood clot­ting dis­or­der. The com­pa­ny wants to swal­low Abl­ynx whole, tak­ing over the en­tire pipeline and keep­ing the Eu­ro­pean op­er­a­tions Abl­ynx has built up in Bel­gium as it ad­vanced its an­ti­body tech­nol­o­gy.

No­vo spelled out its lat­est of­fer of $33.60 per share in cash and one CVR with to­tal po­ten­tial cash pay­ments over time of up to $3 per share. And the bid whipped up an in­stant fren­zy for Abl­ynx’s shares $ABLX, which rock­et­ed up 49%.

Ed­win Moses

No­vo — a ma­jor play­er in the di­a­betes busi­ness — has been work­ing at this buy­out through De­cem­ber, mak­ing its ini­tial of­fer De­cem­ber 7 on­ly to be turned down by the Abl­ynx board a week lat­er. Then they sweet­ened the of­fer to the cur­rent lev­el, but couldn’t get the time of day from the biotech’s board. And it got no bet­ter re­sponse when No­vo CEO Lars Fruer­gaard Jør­gensen called Abl­ynx CEO Ed­win Moses for a chat.

Abl­ynx com­plet­ed its US IPO in Oc­to­ber.

Abl­ynx’s drug capla­cizum­ab tar­gets ac­quired throm­bot­ic throm­bo­cy­topenic pur­pu­ra (aTTP), a dis­or­der that trig­gers low platelet counts. In the Phase III study, re­searchers re­port­ed top-line re­sults that in­clud­ed a sig­nif­i­cant (p=0.01) re­duc­tion in the time it took for the platelet counts to re­turn to nor­mal for the drug arm — a like­ly in­di­ca­tor for the pre­ven­tion of mi­crovas­cu­lar throm­bo­sis.

Sanofi re­cent­ly signed up as the lat­est in a line­up of part­ners work­ing with Abl­ynx, at­tract­ed to a plat­form tech for small “nanobod­ies” which are a sliv­er of the size of reg­u­lar an­ti­bod­ies — mak­ing them bet­ter built for some dis­eases.

Baird’s Bri­an Sko­r­ney couldn’t be hap­pi­er. He ex­pects a bid­ding war may break out.

We think this is on­ly the start­ing point for Abl­ynx as a tar­get and be­lieve we could see oth­er bid­ders come in. We think shares will trade above the of­fer price this morn­ing, with the U.S. shares close to the $30s. We’re re­it­er­at­ing Abl­ynx as one of our top picks for 2018.

Jør­gensen not­ed his ar­dent de­sire to keep Abl­ynx in­tact and its work­ers fo­cused on the pipeline.

“No­vo Nordisk and Abl­ynx share a com­mon fo­cus on in­no­va­tion-dri­ven, pa­tient-cen­tric R&D. No­vo Nordisk in­tends to use its full suite of reg­u­la­to­ry, sci­en­tif­ic and mar­ket­ing ex­per­tise to com­ple­ment the ex­ist­ing strong man­age­ment and med­ical team at Abl­ynx in or­der to op­ti­mise the de­vel­op­ment and glob­al com­mer­cial­i­sa­tion of capla­cizum­ab for the ben­e­fit of pa­tients suf­fer­ing from aTTP.”

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

Image: Shutterstock

Gene ther­a­py R&D deals turn red hot as Big Phar­ma steps up to play

This September will mark the 20th anniversary of the death of Jesse Gelsinger, a young man suffering from X-linked genetic disease of the liver. He was killed in a gene therapy study conducted by Penn’s James Wilson, and the entire field endured a lengthy deep freeze as the field grappled with the safety issues inherent in the work.

Some thought gene therapy R&D would never survive. But it did. And this year marked a landmark approval for Zolgensma, a new gene therapy for spinal muscular atrophy Novartis priced at $2.1 million.

“Gene therapy is the hottest item on the block now. But there was a time when we first got into this trial, where there wasn’t a person in the world who believed that gene therapy would work. We have to remember that,” noted gene therapy investigator Jerry Mendell told SMA News Today.

We’re still right on the pioneering frontier when it comes to getting approvals for gene therapies and launching marketing campaigns with the European green light for bluebird’s leading program last Friday underscoring the nascent nature of the field. But gene therapy R&D is booming, and has been for several years now.

The rapid growth of gene therapy clinical development is well known, but we decided to put some numbers on it, to quantify what’s going on. DealForma chief Chris Dokomajilar took a lot over the past 10 years, as the number of deals, R&D partnerships and buyouts steadily gained steam, spiking last year and on track to maintain the surge in 2019.

The upfronts and totals for the dollars on deals so far in 2019 is already close to the 2018 mark, underscoring a new phase of negotiations as the major players step up to gain a piece of the late-stage and commercial action.

Once again, we’re looking at an “overnight” biotech success story, decades in the making.

At some point, that may start to brake the numbers we’re seeing. But for now, as rivals line up to compete for frontline prominence across a range of diseases, the arrows are all pointed north.

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Albert Bourla appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Pfiz­er CEO Al­bert Bourla is back in the M&A game, but why is he pay­ing $11.4B for Ar­ray?

Pfiz­er $PFE has cut short its time on the side­lines of bio­phar­ma M&A.

Mon­day morn­ing the phar­ma gi­ant un­veiled an $11.4 bil­lion deal to ac­quire Ar­ray Bio­Phar­ma, beef­ing up its on­col­o­gy work and adding a new re­search hub in Boul­der, Col­orado to its glob­al op­er­a­tions.

At $48 a share, Ar­ray $AR­RY in­vestors will be get­ting a 62% pre­mi­um off the Fri­day close of $29.59.

Pfiz­er, which has strug­gled to gain all the up­side promised in past buy­outs like Medi­va­tion, high­light­ed the ac­qui­si­tion of 2 ap­proved drugs in the deal — Braftovi (en­co­rafenib) and Mek­tovi (binime­tinib).

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