RIP amy­loid be­ta the­o­ry? Nope. Bio­gen part­ner launch­es a new PhI­II be­fore ad­u­canum­ab's corpse turned cold

A day af­ter Bio­gen rat­tled the bio­phar­ma world with the news that its lead late-stage ther­a­py ad­u­canum­ab proved worth­less in treat­ing Alzheimer’s — a dis­as­ter that may dri­ve a stake through the heart of the amy­loid be­ta the­o­ry once and for all — the big biotech’s part­ners at Ei­sai have come up with their next big move.


Right in the wake of a 35% plunge in their stock val­ue, Ei­sai $ESALY is start­ing a Phase III study in­volv­ing 1,566 Alzheimer’s pa­tients with mild cog­ni­tive im­pair­ment for the con­tro­ver­sial Alzheimer’s drug BAN2401. The an­ti-amy­loid an­ti­body was the cen­ter of a firestorm of crit­i­cism over a tardy re­veal that re­searchers had pulled high-risk pa­tients out of their last study, po­ten­tial­ly warp­ing the pos­i­tive re­sults that were claimed, leav­ing that drug un­der a dark cloud.

“We still be­lieve that amy­loid be­ta hy­poth­e­sis is po­ten­tial­ly the right ap­proach for the treat­ment of Alzheimer’s dis­ease,” an Ei­sai spokesman told Reuters.

That’s a po­si­tion that Bio­gen ex­ecs will find tough to jus­ti­fy to­day. A whole slate of ma­jor de­vel­op­ers — Eli Lil­ly and As­traZeneca, Mer­ck and Roche — have re­port­ed out de­ci­sive late-stage fail­ures over the last year that all point to one con­clu­sion: Tar­get­ing amy­loid be­ta alone in symp­to­matic pa­tients may hit your bio­mark­ers on ef­fect, but it doesn’t de­lay the ruth­less march of the dis­ease.

Ei­sai and Bio­gen may not have re­ceived the memo, but a whole host of an­a­lysts have writ­ten off BAN2401 as a los­er. As for this new move, don’t ex­pect any sup­port from Leerink’s Ge­of­frey Porges, who es­sen­tial­ly be­lieves any new work like this is dam­ag­ing to in­vestors and pa­tients. He not­ed this morn­ing:

We as­sume that the com­pa­ny (Bio­gen) takes the re­spon­si­ble de­ci­sion to ter­mi­nate all fur­ther in­vest­ments in be­ta amy­loid-di­rect­ed med­i­cines (which has not oc­curred), and saves their in­vestors the cash and saves pa­tients and in­ves­ti­ga­tors from the bur­den of such stud­ies. If Bio­gen does not make this de­ci­sion, then our ad­just­ed ex­pense fore­cast could be too low, with fur­ther neg­a­tive ef­fects on our val­u­a­tion even com­pared to our new PT.

What will be ahead for Bio­gen? Porges is tak­ing a hard line. It’s worth quot­ing him at length.

In our view, Bio­gen finds it­self in the un­en­vi­able po­si­tion of be­ing a wound­ed cash cow (which we are sur­prised man­age­ment and the board did not con­sid­er as a po­ten­tial out­come and pre­pare for). The next few months are like­ly to con­sist of a mix­ture of re­crim­i­na­tions, ex­pla­na­tions, ne­go­ti­a­tions, and pos­si­bly ter­mi­na­tions and lit­i­ga­tion. We ex­pect the com­pa­ny to be dis­tract­ed and ham­pered by those over­hangs for a cou­ple of quar­ters at least. Con­trary to pop­u­lar be­lief we don’t be­lieve that their board or man­age­ment will have the lat­i­tude to im­me­di­ate­ly piv­ot to ma­jor ac­qui­si­tions that would al­ter the com­pa­ny’s out­look ma­te­ri­al­ly (de­spite our sug­ges­tions in the past that such in­vest­ments were ad­vis­able). To­ward the end of this year, af­ter the dust of this dis­ap­point­ment has like­ly set­tled, we ex­pect Bio­gen to ex­plore both as­set sales and as­set pur­chas­es (af­ter oth­er changes have been made, or im­posed by in­vestors). We be­lieve that the case for re­struc­tur­ing and di­vesti­tures will be as com­pelling as the case for ac­qui­si­tions, par­tic­u­lar­ly in the con­text of such poor re­turns from the com­pa­ny’s re­cent cap­i­tal al­lo­ca­tion de­ci­sions.

Bio­gen shares $BI­IB tum­bled 29% on Thurs­day, wip­ing out $18 bil­lion in mar­ket cap. They won’t get any of that back based on the launch of the BAN2401 tri­al. To the con­trary. At a time they need to re­build con­fi­dence, there’s no sign that the part­ners learned any­thing this week.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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