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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.