Atara seeks new CEO as Isaac Ciechanover ex­its; As­traZeneca's Mark Mal­lon tapped to re­place Pe­ter Hecht at Iron­wood

→ In an abrupt de­par­ture, Isaac Ciechanover is step­ping down from Atara Bio­ther­a­peu­tics $ATRA, the T cell ther­a­py com­pa­ny that he found­ed in 2012 in hon­or of his moth­er. The South San Fran­cis­co biotech gave no rea­son for this change, which will take place by June 30, of­fer­ing on­ly the stan­dard thank you and the vi­sion for its pipeline of off-the-shelf CAR-T pro­grams, al­lied with promi­nent in­ves­ti­ga­tors around the coun­try.

Bahi­ja Jal­lal isn’t the on­ly se­nior As­traZeneca ex­ec head­ing to new biotech fields. Mark Mal­lon — cur­rent EVP in charge of port­fo­lio strat­e­gy — is on his way to take the CEO job at Iron­wood $IR­WD, as that com­pa­ny splits up un­der pres­sure and Pe­ter Hecht leaves to run the R&D spin­out.

→ Hav­ing been groomed for the helm at Al­lena Phar­ma­ceu­ti­cals $AL­NA — el­e­vat­ed to the pres­i­dent role with­in two years of join­ing the com­pa­ny as COO — Louis Bren­ner is of­fi­ciall tak­ing over from founder Alex­ey Mar­golin, who is tran­si­tion­ing to the chair­man role. The New­ton, MA-based biotech is de­vel­op­ing oral en­zyme ther­a­peu­tics to treat meta­bol­ic and kid­ney dis­or­ders, with the lead pro­gram relox­aliase set to be­gin Phase III.

→ Spe­cial­ty phar­ma Avadel Phar­ma­ceu­ti­cals $AVDL is part­ing ways with Michael An­der­son and putting Gre­go­ry Di­vis in charge as the in­ter­im CEO. The tem­po­rary pro­mo­tion comes months af­ter Di­vis as­cend­ed from chief com­mer­cial of­fi­cer to the COO post. Avadel’s port­fo­lio cov­ers urol­o­gy, cen­tral ner­vous sys­tem and sleep drugs.

→ Like a long line of No­var­tis ex­ecs be­fore her, Liz Bar­rett has switched to the biotech side of the in­dus­try — helm­ing Uro­Gen, a com­pa­ny she didn’t know un­til ex­ec­u­tive chair­man Arie Bellde­grun con­vinced her to pay a vis­it to its New York City head­quar­ters. Bar­rett takes over from Ron Bentsur just as the com­pa­ny is an­tic­i­pat­ing fi­nal Phase III da­ta for UGN-101, a spe­cial gel for up­per tract urothe­lial can­cer.

Cash rich and poised to be­gin Phase III with a pso­ri­a­sis drug, Der­ma­vant has scooped Philip Brown from Nestlé’s Gal­der­ma to be­come its CMO. Tap­inarof, a top­i­cal cream de­signed to ac­ti­vate the aryl hy­dro­car­bon re­cep­tor, is al­so be­ing ex­plored for atopic der­mati­tis.

Marie Kosco-Vil­bois has left her lengthy tenure at Novim­mune to take up the CSO po­si­tion at AC Im­mune $ACIU, where she will lever­age a deep back­ground in im­munol­o­gy to di­rect the com­pa­ny’s re­search work in neu­rode­gen­er­a­tive dis­eases — in­clud­ing ef­forts in Alzheimer’s, Down syn­drome and Parkin­son’s.

→ As Lon­don’s Verona Phar­ma gears up for a piv­otal COPD tri­al, it’s tapped a pair of Glax­o­SmithK­line vets to lead its clin­i­cal de­vel­op­ment team. Kath­leen Rickard is com­ing on board as CMO while Tara Rheault has been named VP of R&D op­er­a­tions and glob­al project man­age­ment. Both will di­rect R&D ac­tiv­i­ties from the biotech’s US of­fices. The in­haled treat­ment RPL554 showed promise in both COPD and cys­tic fi­bro­sis, trig­ger­ing a ral­ly for the biotech’s stock $VR­NA last March.

→ Fol­low­ing CFO David Grys­ka’s re­tire­ment, In­cyte $IN­CY has found his re­place­ment in Chris­tiana Sta­moulis, a for­mer in­vest­ment banker who’s tak­en a front seat in biotech at Ver­tex and, more re­cent­ly, Unum Ther­a­peu­tics.  

Nim­bus Ther­a­peu­tics is ready to bring a third pro­gram to the clin­ic in 2019, and it’s of­fi­cial­ly hir­ing Big Phar­ma vet Alan Col­lis get the IND in place. Bring­ing ex­pe­ri­ence from Pfiz­er, No­var­tis and For­ma Ther­a­peu­tics, Collins has worked on the ty­ro­sine ki­nase 2 (Tyk2) pro­gram — part­nered with Cel­gene — since Oc­to­ber. He joins as Hol­ly Whittmore and Ab­bas Kaz­i­mi get pro­mot­ed to CFO and VP of busi­ness de­vel­op­ment, re­spec­tive­ly.

→ Af­ter a stint as chief op­er­at­ing of­fi­cer at Ori­gin Bio­sciences, Er­ic Mos­brook­er is re­turn­ing to the com­mer­cial side of things at fel­low rare dis­ease com­pa­ny Au­dentes Ther­a­peu­tics $BOLD. As CCO, the Alex­ion alum will be in charge of de­vis­ing a strat­e­gy and build­ing out a team for the even­tu­al launch of Au­dentes’ gene ther­a­pies, the most ad­vanced of which is still in Phase I/II.

→ Months af­ter nab­bing rights to de­vel­op and sell a home­grown PD-L1 to sell out­side of Chi­na, Shang­hai-based Har­bour Bio­Med is spread­ing its wings in the US, where it has an out­post in Boston. At­ul Desh­pande, who man­aged the Dupix­ent fran­chise for Sanofi’s Gen­zyme, has been tapped to spear­head this ef­fort as chief strat­e­gy of­fi­cer and head of US op­er­a­tions along­side new­ly pro­mot­ed chief de­vel­op­ment of­fi­cer Xi­aox­i­ang Chen and chief busi­ness of­fi­cer Mai-Jing Liao.

→ As Roche-part­nered SQZ Biotech pre­pares to take its first cell ther­a­py in­to the clin­ic, it’s re­cruit­ed Oliv­er Rosen to over­see the clin­i­cal op­er­a­tion as CMO. Most re­cent­ly serv­ing the same role at De­ci­phera Phar­ma, Rosen’s re­sume spans roles at Mil­len­ni­um, Genen­tech, Am­gen and Roche.

DBV Tech­nolo­gies $DB­VT is reshuf­fling its lead­er­ship fol­low­ing an un­ex­pect­ed an­nounce­ment that it’s re­scind­ing the mar­ket­ing ap­pli­ca­tion for its peanut al­ler­gy drug. With Lu­cia Sep­tien-Velez leav­ing for oth­er op­por­tu­ni­ties, CSO Hugh Samp­son will dou­ble as the in­ter­im CMO. Mean­while, CEO Daniel Tassé will now be get­ting ad­vice from Julie O’Neill, a cur­rent board di­rec­tor for­mer­ly of Alex­ion, on prod­uct de­vel­op­ment, man­u­fac­tur­ing, qual­i­ty as­sur­ance, and end-to-end process op­ti­miza­tion in an ef­fort to re­file its BLA for Vi­askin Peanut.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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