Falling be­hind gi­ant mi­graine drug ri­vals, Alder ousts founder Randy Schatz­man — could a buy­out be next?

Ran­dall Schatz­man

Af­ter 14 years at the helm of Alder Bio­Phar­ma­ceu­ti­cals $AL­DR, com­pa­ny co-founder Randy Schatz­man is out in what the com­pa­ny calls a “mu­tu­al de­ci­sion” with the board that it’s time for new lead­er­ship — just ahead of its first mar­ket­ing ap­pli­ca­tion.

Schatz­man will be tem­porar­i­ly re­placed by Paul Cleve­land, who was CEO at the gene ther­a­py com­pa­ny Cel­ladon be­fore it crashed and burned in 2015, even­tu­al­ly serv­ing as a shell for a re­verse merg­er. Ear­li­er he had been an ex­ec­u­tive at Aragon (apa­lu­tamide), ac­quired by J&J, which is what Alder prefers to fo­cus on.

Paul Cleve­land

All niceties aside, Schatz­man was bumped off the ex­ec­u­tive ros­ter at a time that there have been some grow­ing con­cerns about the biotech’s com­pet­i­tive stance. Alder is close to fil­ing a li­cens­ing ap­pli­ca­tion for its CGRP mi­graine drug as it com­pletes piv­otal re­search work.

In­vestors weren’t pleased by the jit­tery move, though. Alder’s stock dropped more than 10% this morn­ing.

Lit­tle Alder is well be­hind the two gi­ants lead­ing the CGRP mi­graine race: No­var­tis and Am­gen, with Aimovig now un­der re­view. Ear­li­er this year, Eli Lil­ly $LLY cel­e­brat­ed its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. Te­va is a play­er, but may be de­layed by man­u­fac­tur­ing is­sues. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front.

Leerink’s Ge­of­frey Porges not­ed that the move to oust Schatz­man comes af­ter grow­ing “frus­tra­tion with the pace of progress, rel­a­tive com­pet­i­tive po­si­tion, and ex­ter­nal dis­clo­sure at Alder, par­tic­u­lar­ly in the last 12-18 months.”

He added:

This lead­er­ship tran­si­tion may have been planned for a while but not pub­licly dis­closed due to the po­ten­tial share­hold­er con­cerns over a CEO leav­ing a com­pa­ny ahead of piv­otal tri­al da­ta. To us, this tim­ing and dis­clo­sure, which ob­vi­ous­ly came di­rect­ly from the board of di­rec­tors, means that the com­pa­ny is free to open­ly re­cruit a leader with the req­ui­site skills and ex­pe­ri­ence or to se­cure the sale of the com­pa­ny.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Frank Zhang (AP Images)

Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”