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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

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

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

David Sabatini (MIT)

For­mer MIT sci­en­tist David Saba­ti­ni fires back at ac­cuser, White­head In­sti­tute for 'false' ha­rass­ment al­le­ga­tions

David Sabatini, the prominent biotech founder who was ousted by the Whitehead Institute and the Howard Hughes Medical Institute this summer over sexual harassment allegations, has filed a lawsuit claiming he was falsely accused by a “former lover” looking to “exact revenge.”

In court documents filed Wednesday, Sabatini claimed he had a consensual sexual relationship with a fellow at the Whitehead Institute, which was “effectively over” by 2019. The suit, which refers to Sabatini as a “brilliant” and “world renowned” scientist, was filed against his accuser, the Whitehead Institute, and director Ruth Lehmann.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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