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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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J&J ad­comm live blog: J&J work­ing on vac­cine for vari­ants, tri­al sched­uled for sum­mer

This week, Moderna announced it would begin testing a modified version of their mRNA vaccine to tackle the vaccine-resistant B1.351 variant that popped up in South Africa. Pfizer said it would test giving people an extra boost of its original vaccine to accomplish the same.

J&J revealed at the adcomm that they, too, have been working on a modified vaccine to tackle emerging variants.

The company didn’t reveal much detail, including how they modified the vaccine or if they were targeting the same B 1.351 variant, but Johan van Hoof said they would begin testing a new construct in the summer. The FDA has said they would allow modified vaccines for variants to be authorized after quick immunological studies that track whether the vaccine elicits antibodies against the new variant.

Gos­samer push­es ahead with failed asth­ma drug; Cull­gen gets $50M Se­ries B for pro­tein de­graders

After getting beaten up by investors over the key failure of its lead drug GB001, Gossamer had already indicated that they thought they could move ahead in asthma, though likely through a partnership. And the biotech is pushing forward on that front, according to a Q4 statement today, following talks with regulators.

The company reported:

Gossamer engaged with the FDA and the EMA about the clinical development path in asthma, and based off those interactions, Gossamer believes that there is a viable clinical development path for GB001, or its backup molecule, in asthma. Gossamer does not currently plan to move forward with GB001, or its backup molecule, in further clinical trials without a partner.