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.”

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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