Af­ter huge mega-round, CStone poach­es Gold­man's Richard Yeh as CFO; Both Hoop­er and Harp­er ex­it Am­gen's re­volv­ing door

→ Weeks af­ter clos­ing its star-stud­ded $260 mil­lion Se­ries B round, CStone Phar­ma­ceu­ti­cals has poached Gold­man Sachs di­rec­tor Richard Yeh to man­age all of that mon­ey and more. As CFO, Yeh’s du­ties will cov­er cor­po­rate fi­nan­cial strate­gies, fi­nan­cial re­port­ing, risk man­age­ment, fund­ing, and IPO. Giv­en CStone’s am­bi­tious plan to go af­ter fron­trun­ners in the PD-L1 field (like Bris­tol-My­ers Squibb’s Yer­voyMer­ck’s Keytru­da and No­var­tis’ Mekin­ist) with its own Phase I drug can­di­date, Yeh is ex­pect­ed to con­tribute in­sight gleaned from his years lead­ing re­search on both Chi­nese and US biotech in­dus­tries. The im­muno-on­col­o­gy play­er has inked a cou­ple of li­cens­ing pacts with US biotechs, in­clud­ing with Agios on ivosi­denib, its new­ly ap­proved treat­ment for ad­vanced acute myeloid leukemia.

Sean Harp­er is join­ing the mi­gra­tion out of big bio­phar­ma and in­to the world of emerg­ing biotechs. The head of R&D at Am­gen has turned in his no­tice, 6 years af­ter tak­ing the se­nior R&D po­si­tion va­cat­ed by Roger Perl­mut­ter. We don’t know right now where he’s head­ed, but in a state­ment Am­gen said the 55-year-old is leav­ing Am­gen and “plans to pur­sue op­por­tu­ni­ties in the ear­ly-stage biotech­nol­o­gy com­mu­ni­ty.” The move opens the door for David Reese, cur­rent­ly se­nior vice pres­i­dent of trans­la­tion­al sci­ences and on­col­o­gy at Am­gen, to move up the lad­der to Harp­er’s spot. He’ll now be in a po­si­tion to run a group that spends about $3.5 bil­lion on drug re­search, fit­ting in­to the world’s top 15 play­ers.

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→ The re­volv­ing door at Am­gen is al­so lead­ing to the re­tire­ment of the glob­al op­er­a­tions chief, An­tho­ny Hoop­er, who is be­ing re­placed by Bris­tol-My­ers Squibb vet Mur­do Gor­don. Bris­tol-My­ers is still search­ing for a new chief com­mer­cial of­fi­cer.

Gilead $GILD CEO John Mil­li­gan is out. In a com­plete­ly un­ex­pect­ed an­nounce­ment, the big biotech com­pa­ny re­port­ed right af­ter the mar­ket close Wednes­day evening that Mil­li­gan will re­main in his po­si­tion un­til the end of the year, as the board looks for his suc­ces­sor. He’s step­ping down, but Mil­li­gan clear­ly has an­oth­er ca­reer chap­ter in mind. “It has been an hon­or to work at Gilead for my en­tire pro­fes­sion­al ca­reer and, now that the com­pa­ny is on sol­id foot­ing for the fu­ture, the Board and I have agreed it is a good time to turn the reins over to a new leader,” said Mil­li­gan in a state­ment. “I’m look­ing for­ward to a well-de­served break and will then move on to new and dif­fer­ent op­por­tu­ni­ties.” Al­so out is Chair­man John Mar­tin, who pre­ced­ed Mil­li­gan at the helm. He plans to leave once the new CEO ar­rives.

NanoVi­ri­cides’ search for CEO Emer­i­tus Eu­gene Sey­mour’s suc­ces­sor has led them to Irach Tara­pore­wala, whose com­bined ex­pe­ri­ence in fundrais­ing, reg­u­la­to­ry af­fairs and qual­i­ty con­trol has proven par­tic­u­lar­ly ap­peal­ing to a com­pa­ny jug­gling half a dozen pre­clin­i­cal an­tivi­ral ther­a­pies. Like Sey­mour, Tara­pore­wala has pre­vi­ous­ly run a com­pa­ny that he found­ed: That would be Ohr Phar­ma, a tiny biotech de­vel­op­ing a wet age-re­lat­ed mac­u­lar de­gen­er­a­tion drug meant to ri­val Lu­cen­tis. Be­fore that, he worked in reg­u­la­to­ry af­fairs at Mys­tic Phar­ma and did drug de­vel­op­ment con­sult­ing for CRO Parex­el.

→ Cana­da’s Wa­ver­ley Phar­ma has tapped Theron Od­laug to re­place out­go­ing CEO George Thomas. Through­out his ca­reer, which start­ed at Bax­ter, Od­laud has trav­eled around the US for roles at Bay­er and Astel­las as well as sev­er­al CEO posts in spe­cial­ty phar­ma com­pa­nies. Most re­cent­ly, he was ex­ec­u­tive chair­man at Toron­to-based Im­pophar­ma. Now, in­stead of nasal and pul­monary drug prod­ucts, he is tasked with steer­ing Wa­ver­ley’s pe­tit pipeline of gener­ic can­cer drugs to the mar­ket.

→ Mark­ing its first pub­lic ap­pear­ance as Lin­i­cal Ac­celo­vance Group, the CRO an­nounced that Vi­ta Lanoce — for­mer­ly COO at Ac­celo­vance — will helm the merged busi­ness. Pri­or to join­ing the com­pa­ny, Lanoce had held stints at Co­v­ance, Synexus and Bris­tol-My­ers Squibb.

→ Back in the spring of 2017, Za­vante CEO Ted Schroed­er was steer­ing his an­tibi­ot­ic Zolyd (fos­fomycin for in­jec­tion, or ZTI-01), plan­ning to squeak past the goal lines at the FDA with­out a pen­ny to spare of his $45 mil­lion in in­vestor back­ing. The an­tibi­ot­ic is an old one, out­side the US, and he had grabbed coun­try rights in ex­pec­ta­tions that it would work as ex­pect­ed. Now, about 15 qui­et months af­ter, we heard that Nabri­va $NBRV is step­ping in to buy the an­tibi­ot­ic and hus­tle it to reg­u­la­tors — in­di­cat­ing that Schroed­er’s old time­line and bud­get may have gone a lit­tle south some­how. The an­tibi­ot­ic is now called Con­tepo, and Schroed­er is still in charge of get­ting it to the FDA. In fact, he’s tak­ing the CEO’s job in the deal, tak­ing the place of Col­in Broom.

→ As part of his plan to put Jerusalem-based Gami­da Cell on the US biotech map, CEO Ju­lian Adams has re­cruit­ed two bio­phar­ma vets to his lead­er­ship team. Tzvi Palash is tak­ing up the COO po­si­tion — ex­act­ly what he’s been do­ing at Pro­tal­ix — bring­ing along some man­u­fac­tur­ing back­ground he earned dur­ing a stint at Is­rael’s Col­Bar Life­Science. He will be joined by VP of mar­ket ac­cess John Schick, an Al­ler­gan vet who’s jump­ing from Kite Phar­ma. Schick is tasked with plan­ning re­im­burse­ment for the com­pa­ny’s cell ther­a­pies, in­clud­ing its cell graft NiCord, a “break­through ther­a­py” cur­rent­ly in Phase III.

→ Or­phan pe­di­atric liv­er dis­ease com­pa­ny Al­bireo $AL­BO has ap­point­ed Tetraphase vet Patrick Horn to over­see the start of its first in-house Phase III tri­al — one put in place by his pre­de­ces­sor Paresh Soni. As CMO, Horn will work with Soni (who re­mains as a con­sul­tant to the com­pa­ny) to push both the lead pro­gram in pro­gres­sive fa­mil­ial in­tra­hep­at­ic cholesta­sis and oth­er ear­ly-stage bile acid mod­u­la­tor as­sets for­ward. A pe­di­a­tri­cian by train­ing, Horn has pre­vi­ous­ly helped Dyax nab an ap­proval for a hered­i­tary an­gioede­ma treat­ment.

Sanofi’s head of hu­man re­sources Rober­to Puc­ci is re­tir­ing af­ter a 9-year run. The French drug­mak­er has brought in Car­o­line Lus­combe from build­ing ma­te­ri­als com­pa­ny La­farge­Hol­cim to take over.

→ Po­si­tion­ing it­self for the com­mer­cial roll­out of its first drug — a sick­le cell dis­ease treat­ment called En­dari Em­maus Life Sci­ences has ap­point­ed two new ex­ecs to watch its num­bers. Sea­soned life sci­ences in­vest­ment banker Kurt Kruger joins as CFO, tak­ing over from Willis Lee, who can now fo­cus on his job in op­er­a­tions. Daniel Frey has been hired as con­troller.

Alex­ion vet Re­bec­ca Frey is now COO at Car­du­ri­on Phar­ma­ceu­ti­cals, a Boston-based up­start look­ing to tack­le car­dio­vas­cu­lar dis­eases that’s sealed a pre­clin­i­cal part­ner­ship with Take­da and a li­cens­ing deal with Astel­las.

→ Af­ter a stint at SQZ Biotech, She­fali Agar­w­al is putting her fresh CMO ex­pe­ri­ence to use at Epizyme $EPZM, where she will be in charge of lead­ing the com­pa­ny’s EZH2 in­hibitor tazeme­to­stat out of trou­bled wa­ters. Weeks ago, the Cam­bridge, MA-based biotech was forced to slam the brakes on any en­roll­ment for its clin­i­cal tri­als of the drug for now as in­ves­ti­ga­tors sort out a pe­di­atric case of sec­ondary T-cell lym­phoma. Agar­w­al, who honed her clin­i­cal de­vel­op­ment skills through­out a ca­reer span­ning Aveo On­col­o­gy, Tesaro and Curis, will al­so spear­head de­vel­op­ment of Epizyme’s oth­er as­sets, such as EZM8266 for sick­le cell dis­ease.

→ Less than three months in­to his CEO ap­point­ment at Abeona Ther­a­peu­tics $ABEO, Carsten Thiel has poached a for­mer col­league from Alex­ion to run its com­mer­cial ops. As chief com­mer­cial of­fi­cer, Max Co­lao will build a team from scratch to pro­mote Abeona’s cell and gene ther­a­pies for rare ge­net­ic dis­eases. Mean­while, COO Jeff Davis will be step­ping down af­ter 10 years at the biotech. Keep­ing track of all the per­son­nel changes will be Kristi­na Maxi­menko, who’s re­cent­ly as­sumed the glob­al head of hu­man re­sources role.

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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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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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.

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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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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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.

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.