Cham­pi­oned by Ab­b­Vie, im­muno-neu­rol­o­gy play­er Alec­tor maps $150M IPO

En­dorsed by Ab­b­Vie, and un­der the lead­er­ship of Genen­tech vet­er­an Arnon Rosen­thal, San Fran­cis­co-based biotech Alec­tor has chart­ed a path to­ward a $150 mil­lion IPO, as it de­vel­ops a crop of drugs de­signed to weaponize the im­mune sys­tem to fight neu­rode­gen­er­a­tive dis­eases, such as Alzheimer’s where re­cent R&D has fo­cused — large­ly in vain — on elim­i­nat­ing tox­ic pro­teins such as amy­loid be­ta.

Alec­tor has based its pipeline on the sci­en­tif­ic the­o­ry that neu­rode­gen­er­a­tion and de­men­tia are caused by dys­func­tion of the im­mune sys­tem, and its ar­se­nal of an­ti­bod­ies-in-de­vel­op­ment are de­signed to ei­ther ac­cel­er­ate the im­mune sys­tem or se­lec­tive­ly re­move the brakes that are in place.

Robert Paul

The biotech is one of the few that are seek­ing to to move past the amy­loid be­ta or tau hy­pothe­ses — a field lit­tered with high pro­file fail­ures. By con­cen­trat­ing on nar­row­er, ge­net­i­cal­ly fo­cused tar­gets, the com­pa­ny hopes it can carve it­self a niche space by de­vel­op­ing monother­a­pies, while oth­ers tin­ker with the po­ten­tial of cock­tails to hit their tar­gets from mul­ti­ple sides.

The com­pa­ny, in a S-1 fil­ing post­ed on Mon­day, is hop­ing to list on the Nas­daq un­der the sym­bol $ALEC.

Since its in­cep­tion in 2013, Alec­tor has test­ed 10 pro­grams pre­clin­i­cal­ly, and tak­en two — AL001 and AL002 — in­to the clin­ic for hu­man stud­ies. AL001, for a form of de­men­tia, is ex­pect­ed to en­ter a Phase Ib study in the first half of 2019 and is ex­pect­ed to be test­ed in a Phase II study in the first half of 2020. AL002, for Alzheimer’s, is in the midst of a Phase I tri­al, which was ini­ti­at­ed in the sec­ond half of 2018. An­oth­er Alzheimer’s drug, AL003, along with AL101 (an ex­per­i­men­tal drug for mul­ti­ple neu­rode­gen­er­a­tive dis­or­ders), are al­so ex­pect­ed to be eval­u­at­ed in Phase I stud­ies this year.

The com­pa­ny is backed by a group of il­lus­tri­ous in­vestors — both bio­phar­ma­ceu­ti­cal com­pa­nies such as Ab­b­Vie $AB­BV, Am­gen $AMGN and Mer­ck $MRK, and in­sti­tu­tion­al in­vestors in­clud­ing Cas­din Cap­i­tal, Deer­field Man­age­ment, Eu­clid­ean Cap­i­tal, Fed­er­at­ed Kauf­mann Fund, Fore­site Cap­i­tal, GV, Lil­ly Asia Ven­tures, Mis­sion Bay Cap­i­tal, New Leaf Ven­ture Part­ners, Or­biMed, Per­cep­tive Ad­vi­sors, Po­laris Part­ners, Sec­tion 32, and the De­men­tia Dis­cov­ery Fund.

In 2017, Ab­b­Vie forked out a mam­moth $205 mil­lion in cash up­front to gain ac­cess to the com­pa­ny’s plat­form. By Ju­ly 2018, the com­pa­ny had raised $420 mil­lion, in­clud­ing the Ab­b­Vie in­vest­ment. Its co-founder and CEO Rosen­thal, who led teams re­spon­si­ble for the de­vel­op­ment of the painkiller tanezum­ab, mi­graine treat­ment Ajovy and spent 16 years at Genen­tech, will work along­side CMO, Robert Paul, who pre­vi­ous­ly served as ther­a­peu­tic area lead for neu­ro­science at Genen­tech.

Im­age: Arnon Rosen­thal. ALEC­TOR

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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