Is a se­vere­ly dam­aged Bio­gen look­ing to shed its ties to a con­tro­ver­sial de­vel­op­ment part­ner?

Af­ter tak­ing it on the chin through­out Thurs­day and Fri­day for its ques­tion­able strat­e­gy of stick­ing with the amy­loid be­ta the­o­ry on Alzheimer’s — topped by the news that its part­ner Ei­sai had picked one of the worst mo­ments pos­si­ble to launch a new Phase III tri­al of their oth­er Alzheimer’s drug BAN2401 — Bio­gen end­ed the week with a state­ment that stopped far short of a ring­ing en­dorse­ment of the move by their col­lab­o­ra­tors.

Here’s what they sent me Sat­ur­day morn­ing:

“We can con­firm that our col­lab­o­ra­tion part­ner, Ei­sai, has is­sued a news re­lease to an­nounce the start of a Phase III with BAN2401. We are work­ing with Ei­sai to eval­u­ate the po­ten­tial next steps for Bio­gen. We are not com­ment­ing fur­ther. Please di­rect your ques­tions to Ei­sai.”

Their oth­er part­nered Alzheimer’s drug is the BACE pro­gram for elen­be­ce­s­tat, which fol­lows in the wake of mas­sive set­backs in the field that in­di­cate turn­ing down the flow of amy­loid be­ta doesn’t work in deal­ing with the dis­ease.

Bio­gen’s stock $BI­IB end­ed the week down more than $100 a share at $216.71, a dis­as­trous 32% plunge on a Phase III fail­ure for ad­u­canum­ab that is lead­ing to un­end­ing spec­u­la­tion about whether the com­pa­ny can work it­self out of the fix it’s in or stands to get bought out it­self.

“(T)his is ab­solute mad­ness,” summed up Baird’s Bri­an Sko­r­ney as he looked over the lat­est de­vel­op­ments.

The ques­tion now is whether Ei­sai will be part of Bio­gen’s fu­ture. That de­ci­sion will rest in large part on Bio­gen CEO Michel Vounatsos, who staked his ca­reer on the now failed ad­u­canum­ab back in the fall of 2017. The CEO re­struc­tured his al­liance with Ei­sai and bought up an in­creased roy­al­ty share in ad­u­canum­ab in a slate of deals that amount­ed to $500 mil­lion in added in­vest­ments.

That big buy-in has come back to haunt him now.

Bio­gen rocked the bio­phar­ma world with the news that it scrapped the late-stage stud­ies for ad­u­canum­ab af­ter con­clud­ing the tri­als were head­ed straight to the rocks — the lat­est in a long string of de­ci­sive fail­ures in the field that has left a line­up of ob­servers ready to con­clude that any new in­vest­ments in the amy­loid be­ta field would be fool­hardy. They’ve al­ready been se­vere­ly crit­i­cized for their work on BAN2401, part­nered with Ei­sai, which be­gan the new Phase III study on Fri­day.

I asked Ei­sai whether Bio­gen had been in touch to re­view its con­tin­u­ing in­volve­ment, which would now ap­pear to be in doubt. A spokesper­son did not an­swer that query,

The two com­pa­nies were hit by a con­tro­ver­sy on BAN2401, you may re­call, af­ter Ei­sai ex­ecs tout­ed ef­fi­ca­cy da­ta and then re­vealed that re­searchers had pulled high-risk pa­tients out of the tri­al, per­haps warp­ing any re­sults.

BAN2401 re­mains one of a hand­ful of drugs still in the clin­ic that is built on the idea that re­duc­ing tox­ic lev­els of amy­loid be­ta can bend the course of the dis­ease. That’s nev­er hap­pened yet, though, with bil­lions spent on the no­tion while Eli Lil­ly, As­traZeneca, Mer­ck and Roche have all con­ced­ed ma­jor late-stage flops in the last year.

Be­ing the last de­fend­er on that hill won’t win any hearts and minds on Wall Street, and Bio­gen needs all the sup­port it can get.

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.

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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.

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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.”

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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.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

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.

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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.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.