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

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.