Pfiz­er spin­out woos Ot­su­ka vet Ray­mond Sanchez to lead CNS pipeline work; Joe An­der­son re­turns to Ar­ix helm

Ray­mond Sanchez

→ Four months af­ter plop­ping it­self down in the cen­ter of the neu­ro­sciences field with a pipeline from Pfiz­er and $350 mil­lion in launch cash from Bain Cap­i­tal, Cerev­el Ther­a­peu­tics has re­cruit­ed a sea­soned cen­tral ner­vous sys­tem drug de­vel­op­er to be­come its CMO. Ray­mond Sanchez, who jumps from Ot­su­ka, is tasked with shep­herd­ing Cerev­el’s Parkin­son’s (dopamine D1 ag­o­nist) and epilep­sy (GA­BA A pos­i­tive mod­u­la­tor) pro­grams in­to Phase III. At the Japan­ese phar­ma, Sanchez over­saw CNS work at Avanir among oth­er re­spon­si­bil­i­ties.

→ Af­ter a brief stint as chief in­vest­ment of­fi­cer, Joe An­der­son is re­turn­ing to his CEO role at biotech start­up builder Ar­ix Bio­science. The for­mer Abing­worth part­ner was first ap­point­ed to the helm in 2016, but switched his fo­cus last Sep­tem­ber to groom the in­vest­ment team and port­fo­lio — some­thing he will con­tin­ue de­vot­ing re­sources to as the Lon­don-based com­pa­ny shifts to­ward a “lean­er” or­ga­ni­za­tion. As part of the tran­si­tion, Jonathan Pea­cock will ex­change his ex­ec­u­tive chair­man badge for the non-ex­ec­u­tive ti­tle, and his for­mer deputy Christo­pher Evans will re­tire from the board.

Dar­rin Dis­ley

→ Se­r­i­al en­tre­pre­neur and for­mer Hori­zon Dis­cov­ery CEO Dar­rin Dis­ley has tak­en the chief ex­ec­u­tive role at Cell Mo­gri­fy, a Cam­bridge, Eng­land-based start­up that just scored $3.7 mil­lion seed fund­ing to pur­sue its work on di­rect cel­lu­lar con­ver­sion. “Di­rect re­pro­gram­ing be­tween ma­ture hu­man cell types” with­out go­ing through a pluripo­tent stem cell or prog­en­i­tor cell state, Dis­ley said, “is a holy grail of re­gen­er­a­tive med­i­cine and phar­ma­ceu­ti­cal ap­pli­ca­tions,” es­pe­cial­ly as the cell ther­a­py field ex­plodes. The new CEO is al­so an in­vestor in the com­pa­ny along­side Ahren In­no­va­tion Cap­i­tal and 24Hay­mar­ket.

Rachelle Jacques

Alex­ion’s Rachelle Jacques is jump­ing ship to an­oth­er rare dis­ease biotech with a big pro­mo­tion: CEO of En­zy­vant Sci­ences, which was forged out of Vivek Ra­maswamy’s pro­lif­ic shop at Roivant back in 2016. Jacques has re­placed Alvin Shih — who was ap­point­ed months af­ter the for­ma­tion of En­zy­vant — as the com­pa­ny preps for the com­mer­cial roll out of RVT-802, a re­gen­er­a­tive ther­a­py de­signed to re­con­sti­tute the im­mune sys­tem to treat pri­ma­ry im­mune de­fi­cien­cy re­sult­ing from con­gen­i­tal athymia. She pre­vi­ous­ly served as se­nior VP and glob­al fran­chise head of com­ple­ment at Alex­ion, and has al­so worked with Shire, Bax­al­ta, Bax­ter and Dow Corn­ing.

Rosa­mond Dee­gan is step­ping down as pres­i­dent and chief busi­ness of­fi­cer at Bi­cy­cle Ther­a­peu­tics, trig­ger­ing a pro­mo­tion and a new hire to fill the two po­si­tions. Lee Kalows­ki, the biotech’s CFO, will be­come pres­i­dent of its US op­er­a­tions (it has of­fices in both Cam­bridges across the At­lantic). Mean­while, Pe­ter Leone jumps from Ar­row­head Phar­ma to lead busi­ness de­vel­op­ment ef­forts for Bi­cy­cle’s bi­cyclic pep­tide plat­form.

Roche-part­nered gene ther­a­py com­pa­ny 4D Mol­e­c­u­lar Ther­a­peu­tics is stack­ing up its C-suite with a string of ap­point­ments and pro­mo­tions. Fred Ka­mal is com­ing on board as chief tech­ni­cal of­fi­cer af­ter over­see­ing qual­i­ty and reg­u­la­to­ry CMC for Avex­is as well as Juno. Au­gust Moret­ti, for­mer­ly of As­ser­tio Ther­a­peu­tics and Alexza Phar­ma­ceu­ti­cals is the new CFO. Pe­ter Fran­cis and There­sa Janke have been pro­mot­ed to chief med­ical of­fi­cer and chief op­er­at­ing of­fi­cer re­spec­tive­ly; Fran­cis is an oph­thalmic ge­net­ics ex­pert while Janke is a found­ing mem­ber of the com­pa­ny.

→ As Red­Hill Bio­phar­ma $RDHL gears up for a po­ten­tial US launch of its an­tibi­ot­ic Tal­i­cia,  it’s tapped Rick Scrug­gs as COO of its US op­er­a­tions. A board mem­ber since 2016, Scrug­gs learned the ropes of drug com­mer­cial­iza­tion at Sal­ix Phar­ma un­til Valeant bought it up. The Is­raeli biotech is plot­ting a fourth quar­ter roll­out for Tal­i­cia, which re­cent­ly re­port­ed a Phase III suc­cess in erad­i­cat­ing H. py­lori in­fec­tion.

Doug Williams has wooed a for­mer Bio­gen col­league to his start­up team at Co­di­ak Bio­Sciences. An­drea Di­Fabio has been named chief le­gal of­fi­cer, a post she al­so oc­cu­pied re­cent­ly at Biover­a­tiv (now a Sanofi sub­sidiary). Aside from her le­gal ex­per­tise, Di­Fabio is al­so ex­pect­ed to con­tribute to cor­po­rate strat­e­gy and trans­ac­tion­al dis­cus­sions, Williams said.

→ Fol­low­ing sev­er­al pacts with high pro­file part­ners on its RNAi pro­grams, Dicer­na $DR­NA is beef­ing up its lead­er­ship team. Hard­ean Ach­neck, a for­mer CMO at stem cell ther­a­py de­vel­op­er He­mo­stemix, is the new VP, head of med­ical de­vel­op­ment; Paratek alum Regi­na DeTore Paglia has been ap­point­ed as SVP of hu­man re­sources; and new head of cor­po­rate com­mu­ni­ca­tions Re­bec­ca Pe­ter­son brings two decades of ex­pe­ri­ence from the likes of Mil­len­ni­um, Alk­er­mes and Sanofi Gen­zyme.

Log­icBio Ther­a­peu­tics has re­cruit­ed Ken­neth Hut­tner from Biover­a­tiv to its ef­fort treat­ing rare dis­eases with gene edit­ing. As SVP, head of clin­i­cal de­vel­op­ment, Hut­tner will play a key role in ad­vanc­ing the com­pa­ny’s $LOGC lead pro­gram for methyl­malonic acidemia in­to the clin­ic.

→ Hav­ing lost a bid (and a for­tune) in a run for a New Jer­sey Sen­ate seat last fall, for­mer Cel­gene CEO Bob Hug­in is mak­ing a leap back in­to biotech. He is join­ing the board of Al­ler­gan $AGN at a time the com­pa­ny, un­der pres­sure from the hedge fund Ap­paloosa LP to di­vide the role of chair­man and CEO, is slow­ly thaw­ing to the idea of re­vamp­ing its lead­er­ship struc­ture. His ap­point­ment, though, has on­ly in­spired a back­lash from the ac­tivist in­vestor, which de­scribed its as “a lame at­tempt to de­flect pres­sure through to­ken mea­sures.”

Gos­samer founder Fa­heem Has­nain (of Re­cep­tos fame) is tak­ing over the board chair­man seat at Mi­rati Ther­a­peu­tics as Rod­ney Lappe re­tires from the ge­net­ics-dri­ven can­cer drug de­vel­op­er.  

Kather­ine High, co-founder and head of R&D at gene ther­a­py pi­o­neer Spark Ther­a­peu­tics, is one of two pro­posed new mem­bers join­ing the board of CRISPR Ther­a­peu­tics. The biotech, which counts it­self a fron­trun­ner in race to de­vel­op ther­a­pies with its name­sake gene edit­ing tool, has al­so in­vit­ed Biover­a­tiv CFO John Greene to be a di­rec­tor.

→ In a push to raise its pro­file glob­al­ly, Dis­cov­ery Park — a sci­ence cam­pus based in the south­east­ern part of Eng­land — has ap­point­ed Chris Broom as head of busi­ness de­vel­op­ment.

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.

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. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

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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