Fred Aslan re­turns to biotech as pres­i­dent of Vi­vid­ion; Zai Lab scoops Por­to­la's Tao Fu to spear­head US op­er­a­tions

Fred Aslan

→ Af­ter a stint as CEO of a med­ical de­vice com­pa­ny, Re­cep­tos co-founder and Ven­rock alum Fred Aslan is back in the drug de­vel­op­ment busi­ness. As pres­i­dent and chief busi­ness of­fi­cer of Vi­vid­ion Ther­a­peu­tics, he will play a cru­cial role in en­gi­neer­ing deals to fi­nance the mul­ti­ple ap­pli­ca­tions of Vi­vid­ion’s syn­thet­ic and pro­teom­ic chem­istry plat­forms, which has al­ready scored a big col­lab­o­ra­tion with Cel­gene. Vi­vid­ion has al­so wooed Lar­ry Burgess — long­time ex­ec at Ar­ray Bio­phar­ma — to be­come its head of chem­istry.

→ Re­mem­ber when Tao Fu qui­et­ly re­signed from his post as chief com­mer­cial and busi­ness at Por­to­la? It turns out he was prep­ping a move to Zai Lab $ZLAB, where he’s been ap­point­ed pres­i­dent and COO with re­spon­si­bil­i­ty on every­thing from busi­ness de­vel­op­ment to man­u­fac­tur­ing. The Shang­hai-based biotech likes his US ex­pe­ri­ence — ac­crued over years of work­ing for J&J and Bris­tol-My­ers Squibb — which will come in­to play as they open up their US head­quar­ters around his of­fice in San Fran­cis­co.

→ Wern­er Cautreels, the long­time CEO at Se­lec­ta Bio­sciences $SELB, is re­tir­ing from his post. The biotech re­port­ed this morn­ing that Bay­er vet Carsten Brunn has been named as the new CEO. Cautreels is stay­ing on as an ad­vis­er af­ter he leaves his job at the end of this year. Se­lec­ta is prep­ping a Phase III study for SEL-212, an ex­per­i­men­tal gout drug. Cautreels was named CEO in 2010, a cou­ple of years af­ter the launch of the com­pa­ny fo­cused on syn­thet­ic vac­cine par­ti­cle tech from the lab of MIT’s Bob Langer.

Karim Dab­bagh

→ There’s been a change of lead­er­ship — and strat­e­gy — at one of the Bay Area biotechs look­ing to play a promi­nent role in mi­cro­bio­me R&D. Glenn Ned­win is out as CEO of Sec­ond Genome, leav­ing the top post open for chief sci­en­tif­ic of­fi­cer Karim Dab­bagh to step in­to. Al­so out is the broad-based ap­proach to R&D that Ned­win had, in­clud­ing ag work, as the biotech looks to cre­ate a ra­zor-sharp fo­cus on an up­com­ing Phase II for NASH — a block­buster tar­get which has in­spired a fren­zy of com­pe­ti­tion. Dab­bagh’s next chap­ter as CEO will cen­ter on SGM-1019, a P2X7 in­hibitor that in­hibits NL­RP3, an in­flam­ma­some that has been at­tract­ing a broad group of play­ers.

→ Ali Fat­taey is out as CEO of Curis. The Lex­ing­ton, MA-based biotech says Fat­taey is leav­ing the com­pa­ny, which is about all it has to say about that. The ex-CEO was cred­it­ed with hir­ing his re­place­ment, COO James Dentzer, now pres­i­dent and CEO. “Look­ing for­ward, we be­lieve (Dentzer) is best po­si­tioned to lead Curis as we seek to progress our three high-val­ue pro­grams quick­ly and suc­cess­ful­ly through the clin­ic,” says chair­man Mar­tyn Greenacre.

→ As Ma­rizyme com­pletes the ac­qui­si­tion of its pro­tease plat­form — and some drug can­di­dates de­vel­oped on it — the biotech has ap­point­ed Michael Han­d­ley as its new CEO. Han­d­ley takes over from Nick De­Vi­to and has the big task of re­al­iz­ing Ma­rizyme’s vi­sion for buy­ing late-stage prod­ucts in the acute care space to push them over the reg­u­la­to­ry fin­ish line.

Nau­tic Part­ners has hired biotech vet Michael Kallelis to run Mikart, the con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion it just bought.

Volk­er Her­rmann

→ Weeks af­ter clos­ing a $72 mil­lion round, Ar­mon Sharei, the young founder and CEO at SQZ Biotech has brought in an in­dus­try vet­er­an to shape the biotech’s cor­po­rate strat­e­gy, op­er­a­tions and com­mu­ni­ca­tions as it ap­proach­es the clin­ic. Volk­er Her­rmann’s of­fi­cial ti­tle is pres­i­dent and COO, but he will al­so take over the busi­ness de­vel­op­ment front. A Pfiz­er vet, Her­rmann first made the jump to biotech for Vi­amet Phar­ma­ceu­ti­cals and had since worked as COO of Se­len­i­ty Ther­a­peu­tics.

→ Ramp­ing up for piv­otal stud­ies for an old Sanofi drug, X4 Phar­ma­ceu­ti­cals has ap­point­ed Adam Mostafa as CFO. While Mostafa most re­cent­ly served in the same po­si­tion at Abpro, he spent most of his ca­reer in the in­vest­ment bank­ing world, capped by a stint as man­ag­ing di­rec­tor at Can­tor Fitzger­ald.  

→ Hav­ing steered Gen­fit’s lead drug, elafi­bra­nor, to a Phase III pro­gram, CMO So­phie Még­nien has de­cid­ed to re­sign from the com­pa­ny but em­pha­sizes that the de­ci­sion is “en­tire­ly per­son­al and is to­tal­ly un­re­lat­ed to Gen­fit or its R&D pro­grams” — pre­sum­ably in re­sponse to ru­mors that she has an of­fer to join a com­peti­tor. Pas­cal Bir­man, her for­mer deputy, is step­ping up to lead the clin­i­cal team.

→ Scrap­ping for cash to pro­duce ad­di­tion­al safe­ty da­ta re­quest­ed by the FDA be­fore it could pro­ceed with its lead drug, Gem­phire has cut in­to its C-suite for a round of lay­offs. The re­duc­tion — which claims five staffers, or a third of the tiny biotech’s work­force — caps a tur­bu­lent few months at Gem­phire $GEMP dur­ing which its shares were bat­tered. Among the five laid off are CFO Jef­frey Math­iesen and CMO Lee Gold­en. CEO Steven Gul­lans will now dou­ble as the prin­ci­pal fi­nan­cial and ac­count­ing of­fi­cer of the com­pa­ny.

Mer­ck vet Arthur San­to­ra has joined a new­ly pub­lic En­tera $EN­TX as its CMO, re­plac­ing Er­ic Lang. The Jerusalem-based biotech is de­vel­op­ing oral for­mu­la­tions of parathy­roid hor­mone (PTH) for os­teo­poro­sis and hy­poparathy­roidism.

→ With Phase III tri­als for its non-opi­oid, non-steroid pain drug un­der­way, Cen­trex­ion Ther­a­peu­tics is ready to talk com­mer­cial­iza­tion. An­drew Par­tridge, for­mer­ly of Ver­tex and Am­gen, is the new EVP and CCO tasked with build­ing out the team.

→ Emerg­ing from the Nu­plazid scan­dal af­ter an FDA re­view con­clud­ed the Parkin­son’s drug car­ries more ben­e­fit than risks, Aca­dia is now ready to move on with this and oth­er clin­i­cal pro­grams in cen­tral ner­vous sys­tem dis­or­ders, an­nounc­ing two new hires. Organon vet Robert Kaper has joined as SVP, glob­al head of med­ical af­fairs, while Eliseo Sali­nas as­sumes the CSO and SVP post af­ter hop­ping around a slate of biotechs.

Mit­subishi Tan­abe Phar­ma Amer­i­ca has re­cruit­ed Joseph Scalia from Bay­er to head its US op­er­a­tions as VP of com­mer­cial sales and mar­ket­ing.

Ea­gle Phar­ma­ceu­ti­cals $EGRX has el­e­vat­ed chief com­mer­cial of­fi­cer David Per­nock to the COO role, while keep­ing pres­i­dent in his ti­tle, in prepa­ra­tion for the “next phase in com­mer­cial­iza­tion” of their in­jecta­bles.

→ Har­vard pro­fes­sor and Broad re­searcher David Liu — wide­ly rec­og­nized for his work on gene edit­ing and syn­thet­ic bi­ol­o­gy, with a cou­ple of biotech star­tups un­der his belt — has joined the board of WuXi Bi­o­log­ics.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA.