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.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

No­var­tis is ax­ing 150 ear­ly dis­cov­ery jobs as CNI­BR shifts fo­cus to the de­vel­op­ment side of R&D

Novartis is axing some 150 early discover jobs in Shanghai as it swells its staff on the drug development side of the equation in China. And the company is concurrently beefing up its investment in China’s fast-growing biotech sector with a plan to add to its investments in local VCs.

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No­var­tis is eye­ing a multi­bil­lion-dol­lar Med­Co buy­out as Jer­sey biotech nears NDA — re­ports

To get from Novartis’ US headquarters to the Medicines Company, you make a left out of a square concrete building on NJ-Route 10, follow it past the sun orange veranda of Jersey’s Hot Bagels and the inexplicable green Vermont cabin that houses the Whippany Railway Museum until you turn right and immediately arrive at a rectangular glass building. It should take you about 12 minutes.

Reports are out that Novartis may be making that trip. Amid a torrent of Phase III data burnishing MedCo’s chances at a blockbuster cholesterol drug,  Bloomberg News is reporting that Novartis is looking to acquire the Jersey-based biotech.

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UP­DAT­ED: In a land­mark first glimpse of hu­man da­ta from Ver­tex, CRISPR/Cas9 gene ther­a­py sig­nals ear­ly ben­e­fit

Preliminary data on two patients with blood disorders that have been administered with Vertex and partner CRISPR Therapeutics’ gene-editing therapy suggest the technology is safe and effective, marking the first instance of the benefit of the use of CRISPR/Cas9 technology in humans suffering from disease.

Patients in these phase I/II studies give up peripheral blood from which hematopoietic stem and progenitor cells are isolated. The cells are tinkered with using CRISPR/Cas9 technology, and the edited cells — CTX001 — are infused back into the patient via a stem cell transplant. The objective of CTX001 is to fix the errant hemoglobin gene in patents with two blood disorders: beta-thalassemia and sickle cell disease, by unleashing the production of fetal hemoglobin.

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Badrul Chowdhury. FDA via Flickr

As­traZeneca los­es an­oth­er ex­ec­u­tive to biotech, as Badrul Chowd­hury moves to Savara

Another executive is migrating from the echelons of Big Pharma to the corridors of small biotech.

In April 2018, Badrul Chowdhury took his more than two decades of experience at the FDA to AstraZeneca, where he took on the role of senior vice president and chief physician-scientist for respiratory, inflammation and autoimmunity late-stage development in biopharmaceuticals R&D.

After about a year and a half in this role, Chowdhury is moving to a small Texas biotech called Savara, where he will serve as chief medical officer.

Yiannis Kiachopoulos and Artur Saudabayev, co-founders of Causaly

Lon­don AI up­start, which counts No­var­tis as a cus­tomer, can teach your com­put­er to read

When Amazon developed a machine-learning tool to make its recruitment process more efficient — the man-made system absorbed the gender-bias of its human makers, and the project was aborted. In the field of biopharmaceuticals, the way researchers train their machine learning algorithms can skew the outcome of predictions. But before those predictions can be made, the engine must learn to read to make sense of explosive volume of knowledge out there.

Burt Adelman. Novo Ventures

Here's a $25M seed fund aimed at back­ing some brash new drug ideas out of the Broad

As a former academic and a seasoned drug developer, Burt Adelman knew when he was recruited as a senior advisor to Novo Ventures in 2017 that one of his key priorities needs to be introducing the fund to the network he was so deeply embedded in.

“I was thinking long and hard on how can I, as a Boston insider, help Novo really get inside the ecosystem of Boston biotech?” he recalled in an interview with Endpoints News.

Welling­ton lines up a $393M bankroll for its next round of pri­vate biotech bets — and they’re like­ly think­ing big

Wellington Management made some uncustomary waves at the beginning of the year when it threw its considerable weight against Bristol-Myers Squibb’s $74 billion Celgene buyout. But after Bristol-Myers’ biggest investor conceded that game to the influential proxy firms involved, they’re now going to end the year by rolling out a big new investment fund for a new stable of fledgling biotechs on the private side of the industry.

As uter­ine race with Ab­b­Vie heats up, My­ovant eyes FDA ap­proval with tri­al re­sults from prostate can­cer

Myovant has long had a secret weapon in its uterine rivalry with AbbVie: Men.

While the small Swiss biotech has jockeyed with the Illinois-based giant for a foothold in the endometriosis and uterine fibroid therapy market, the company has been developing the same lead compound, relugolix, for use in one of the most common cancers for the uterus-less: prostate cancer. Today, Myovant is out with positive topline results from its big Phase III trial on the gonadotropin-releasing hormone (GnRH) antagonist. They say they’ve reached every primary and secondary endpoint with p values less than .0001.