Brent Saun­ders’ team gets hit with a PhI­II dis­as­ter — and a grow­ing mob of Al­ler­gan crit­ics seizes the mo­ment

Usu­al­ly when a large cap bio­phar­ma com­pa­ny has a big Phase III dis­as­ter, the top ex­ecs give it a quick mid­night bur­ial, is­sue a brief press re­lease, put up with a few head­lines, watch the mar­ket cap erode a bit and move on down the pipeline.

For Al­ler­gan $AGN, it’s a lot more com­pli­cat­ed than that.

Al­ready un­der pres­sure from the hedge fund Ap­paloosa to split the roles of CEO and chair­man in Brent Saun­ders’ shop, the ac­tivists point­ed to the de­ba­cle with ra­pastinel — Saun­ders’ $560 mil­lion de­pres­sion drug that flat failed a full slate of piv­otal tri­als — as an­oth­er sign that some­one needs to set things right at the com­pa­ny. And that no longer stops with a new chair­man to help steer a bet­ter course. Ap­paloosa wants to put a re­vamp of the man­age­ment team on the ta­ble, along with a sale, breakup or merg­er.

The Board’s mis­placed fear of “dis­rupt­ing” Al­ler­gan is wear­ing thin as an ex­cuse for in­ac­tion and can on­ly per­pet­u­ate fur­ther ero­sion in the share­hold­ers’ in­vest­ment. In fact, dis­rup­tive ac­tion is en­tire­ly war­rant­ed un­der these cir­cum­stances.” (Their em­pha­sis.)

But that’s not all. Af­ter steer­ing in­to the red on the set­back — the nor­mal, ra­tio­nal mar­ket re­sponse — Al­ler­gan’s shares are up 5% mid-day Thurs­day. And that’s be­cause the calls for ma­jor change at Al­ler­gan could gain re­al steam now. 

Ever­core ISI’s Umer Raf­fat spot­light­ed the pos­si­bil­i­ty of a break in­to the green ear­ly to­day.

It seems that in­vestors seem ex­treme­ly fo­cused on un­lock­ing the val­ue of aes­thet­ics busi­ness amidst the phar­ma busi­ness (which has had a few years of un­der­per­for­mance: on the patent side on base biz and on pipeline pro­duc­tiv­i­ty).

RBC’s Ran­dall Stan­icky has been ad­vo­cat­ing a breakup for more than a year. So count him in on the crowd of­fer­ing a thumbs up to fail­ure, which will just dri­ve more calls for quick change.

And SVB Leerink’s Marc Good­man al­so pre­dict­ed the switch to green to­day:

Re­gard­ing the stock, in­vestors have in­di­cat­ed to us that if ra­pastinel fails there could be (and should be) in­creased pres­sure on man­age­ment and/or the Board to im­ple­ment some type of change.

There’s al­so been some spec­u­la­tion that the man­age­ment team may have held back the first fail­ures to get an­oth­er read­out on the drug. Some­thing like that would on­ly fur­ther fu­el the al­ready blis­ter­ing feed­back Saun­ders’ been get­ting from some quar­ters.

Saun­ders may find the lat­est roast­ing was just a mod­est pre­lude to what comes next.

Im­age: Brent Saun­ders.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Robert Gould, Fulcrum Therapeutics CEO

Ful­crum stum­bles in PhII of old GSK drug, send­ing shares tum­bling

Investors are selling off shares of Fulcrum Therapeutics $FULC after their lead drug failed in a Phase II trial.

The company, founded three years ago on new research techniques such as CRISPR screening, isolated a gene called DUX4 they believed to have a central role in facioscapulohumeral muscular dystrophy, where patients’ muscle dies and is replaced by fat. And to target it, they licensed a GlaxoSmithKline drug that had failed as a cardio drug.

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Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

Lig­and scoops up Pfenex for up to $516M, adding pro­teins to their an­ti­body chick­ens and de­liv­ery tech

The technology hunting folks over at Ligand Pharmaceuticals have picked up a new one from across town, for a significant price.

Ligand has acquired fellow San Diego-based biotech Pfenex and their protein expression platform for $438 million cash, plus $78 million in contingent value agreements should an undisclosed milestone be hit before the end of next year.  The deal pays $12 per share, or $4.34 more than what Pfenex had been trading at before the announcement.