Cel­gene's Michael Pehl leaps up to lead role at Im­munomedics; GSK nabs Hal Bar­ron to helm R&D; Aim­mune CEO to step down

Michael Pehl

Michael Pehl will take the top job at Im­munomedics next month af­ter 11 years at Cel­gene, where he was most re­cent­ly head of hema­tol­ogy and on­col­o­gy. As pres­i­dent and CEO, his pri­or­i­ty will be push­ing for the ap­proval and mar­ket­ing of an­ti­body-drug con­ju­gate IM­MU-132. On his side will be fel­low Cel­gene vet Bren­dan De­laney, who has been named chief com­mer­cial of­fi­cer.

Por­to­la Phar­ma­ceu­ti­cals has brought on John (Jack) Lawrence, pre­vi­ous­ly VP and head of car­dio­vas­cu­lar at Bris­tol-My­ers Squibb, as CMO. “Jack’s rep­u­ta­tion and achieve­ments in glob­al throm­bo­sis prod­uct de­vel­op­ment and reg­u­la­to­ry ap­provals will be valu­able as­sets to Por­to­la as we be­gin to launch be­trix­a­ban and pre­pare for the po­ten­tial ap­proval of an­dex­anet in 2018,” said com­pa­ny $PT­LA CEO William Lis in a state­ment. “We’re pleased to add his ex­ec­u­tive lead­er­ship and ex­per­tise to our man­age­ment team to help us con­tin­ue to ad­vance Por­to­la as a lead­ing throm­bo­sis and hema­to­log­ic biotech­nol­o­gy com­pa­ny.”

→ In an ap­par­ent at­tempt to stir up its lack­lus­ter drug de­vel­op­ment, Glax­o­SmithK­line has re­cruit­ed in­dus­try leg­end Hal Bar­ron to re­place Patrick Val­lance (who left for a gov­ern­ment job) as R&D chief. De­part­ing from an­ti-ag­ing start­up Cal­i­co, Bar­ron is the lat­est high pro­file ex-Googler to leave a Sil­i­con Val­ley life sci­ence com­pa­ny.

→ Bris­bane, CA-based Aim­mune $AIMT CEO Stephen Dil­ly says he plans to step down by the end of 2018 so he can spend more time with his fam­i­ly. The biotech plans to mount a search for a new CEO. Dil­ly not­ed: “My de­ci­sion to re­tire is based sole­ly on my per­son­al de­sire to have more time for my fam­i­ly, es­pe­cial­ly my el­dest son, who has spe­cial needs. We are an­nounc­ing this now in or­der to fa­cil­i­tate an or­der­ly ex­ec­u­tive search and tran­si­tion pe­ri­od, and I re­main com­plete­ly com­mit­ted to con­tin­u­ing to lead Aim­mune through the ex­cit­ing events ahead. We are look­ing for­ward to the com­ple­tion of our piv­otal Phase 3 PAL­ISADE tri­al around year-end and shar­ing top-line da­ta in the first quar­ter of 2018.”

Trans­late Bio CEO Ron Re­naud has re­cruit­ed Agios vet Ann Bar­bi­er for the CMO po­si­tion. Bar­bi­er had been vice pres­i­dent of clin­i­cal de­vel­op­ment, rare ge­net­ic dis­eases at Agios, a trend­set­ter in the Cam­bridge, MA biotech hub. Ear­li­er, she had worked at Shire for 7 years. “With near-term clin­i­cal pro­grams in cys­tic fi­bro­sis and OTC de­fi­cien­cy, Trans­late Bio is ap­proach­ing a crit­i­cal and ex­cit­ing time,” said Bar­bi­er.

Alder Bio­Phar­ma­ceu­ti­cals is part­ing ways with Tim­o­thy Whitak­er a year and a half af­ter ap­point­ing him as chief med­ical of­fi­cer. Whitak­er, a Shire vet, will work as a con­sul­tant for Alder $AL­DR as it ad­vances tri­als for epitinezum­ab and pre­pares to file a bi­o­log­ics li­cense ap­pli­ca­tion for it in the sec­ond half of 2018 — some­thing the com­pa­ny made sure to men­tion in the 8-K.

→ Cam­bridge, UK-based out­sourced drug dis­cov­ery and de­vel­op­ment com­pa­ny Rx­Cel­er­ate is open­ing an of­fice in Cam­bridge, MA, and it has tapped Lau­ra Hamil­ton to run its drug dis­cov­ery and de­vel­op­ment op­er­a­tion there. Hamil­ton, whose of­fi­cial ti­tle is ex­ec­u­tive vice pres­i­dent of US op­er­a­tions, will lever­age her con­nec­tions she built over the years at the lo­cal trade as­so­ci­a­tion Mass­Bio to in­tro­duce com­pa­nies to Rx­Cel­er­ate’s ser­vices. CEO Jill Reck­less ex­pressed high hopes in a state­ment: “We are bring­ing Rx­Cel­er­ate’s unique mod­el for out-sourced drug dis­cov­ery and de­vel­op­ment to the heart of the largest and most vi­brant life sci­ences clus­ter on the plan­et.”

Daniel O’Con­nor

→ Mi­cro­cap biotech On­coSec $ONCS had quite a bit to cel­e­brate this week: im­pres­sive da­ta on its com­bo drug Im­munoPulse IL-12, came right at the heels of new CEO Daniel O’Con­nor’s ap­point­ment. O’Con­nor takes the reins from co-founder Punit Dhillon, and is ex­pect­ed to lead the com­pa­ny in­to com­mer­cial launch with his ex­pe­ri­ence head­ing Ad­vax­is as CEO.

→ Chief busi­ness and strat­e­gy of­fi­cer Rachel McMinn has re­signed from In­ter­cept Phar­ma­ceu­ti­cals, an SEC fil­ing shows. Tak­ing with her $5,000 in le­gal fees re­lat­ed to the sep­a­ra­tion agree­ment, the for­mer biotech an­a­lyst will re­main a spe­cial ad­vis­er to the com­pa­ny $ICPT un­til the end of the year.

David Reck­er, who’s spent time at Take­da and Veri­cel, is now the CMO at Neu­ral­stem $CUR, the ner­vous sys­tem dis­eases bio­phar­ma slow­ly re­cu­per­at­ing from a cou­ple fail­ures in Ju­ly.

Mary Szela

→ Af­ter re­or­ga­niz­ing Aege­ri­on and lead­ing the com­pa­ny through the merg­er with QLT that turned it in­to Nov­e­l­ion, CEO Mary Szela is leav­ing her po­si­tion for per­son­al rea­sons. Her res­ig­na­tion is ef­fec­tive im­me­di­ate­ly, and while the rare dis­ease biotech $NVLN search­es for a new CEO, a team of three ex­ecs will fill the of­fice. Lat­er this month, Mur­ray Stew­art will join as EVP and head of R&D, as the com­pa­ny pre­pares to launch Jux­tapid in Japan and an­tic­i­pates an EMA ap­proval for me­treleptin (Myalept) ear­ly next year.

→ As cur­rent chief op­er­a­tion of­fi­cer Lynne Par­shall tran­si­tions in­to a strate­gic ad­vis­er role at Io­n­is Phar­ma­ceu­ti­cals, Brett Mo­nia, head of drug dis­cov­ery, will as­sume the COO po­si­tion. A found­ing mem­ber of Io­n­is $IONS, Mo­nia al­so leads the in­ot­ersen pro­gram, which was filed for a mar­ket­ing ap­proval with the FDA ear­li­er this week. His new re­spon­si­bil­i­ties in­clude mov­ing re­search pro­grams in­to de­vel­op­ment, reg­u­la­to­ry, pa­tient ad­vo­ca­cy, hu­man re­sources and busi­ness func­tions. “The board and I are con­fi­dent that Brett is the ide­al choice to be chief op­er­at­ing of­fi­cer and is ful­ly pre­pared to as­sume these new re­spon­si­bil­i­ties,” said CEO Stan­ley Crooke in a state­ment.


With ad­di­tion­al re­port­ing from John Car­roll

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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