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.”

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.