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

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took a 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

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While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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