J&J R&D vet Pe­ter Tum­mi­no joins the Big Phar­ma ex­o­dus, leap­ing to Nim­bus as CSO; Ca­dent taps Jodie Mor­ri­son for CEO

→ Af­ter spend­ing the last 16 years as a re­searcher in Big Phar­ma, Pe­ter Tum­mi­no is go­ing biotech.

Pe­ter Tum­mi­no

Nim­bus re­ports that Tum­mi­no is join­ing the com­pa­ny as its new CSO af­ter his last stint at J&J, where he was glob­al head of lead dis­cov­ery and head­ed up re­search teams on both sides of the At­lantic. Ear­li­er he had a long stretch at GSK, where he ran the can­cer epi­ge­net­ics team, among oth­er things.

Nim­bus made head­lines in the in­dus­try with its $400 mil­lion up­front deal with Gilead on NASH. But it’s al­so been com­plete­ly re­vamp­ing the top team. CEO Don Nichol­son left last fall, short­ly af­ter a $65 mil­lion raise, re­placed by Jeb Keiper.  And found­ing CSO Rosana Kapeller fol­lowed  out the ex­it soon af­ter, lat­er join­ing Google’s GV as its first en­tre­pre­neur-in-res­i­dence for life sci­ences. 

We’ve seen a large ex­o­dus of R&D ex­ecs out of phar­ma in re­cent years, as se­nior re­searchers with years of ex­pe­ri­ence in large or­ga­ni­za­tions try their hand at the small­er biotechs, where new op­por­tu­ni­ties have abound­ed.

Jodie Mor­ri­son

Jodie Mor­ri­son has been tapped CEO of Ca­dent Ther­a­peu­tics, free­ing Michael Cur­tis to fo­cus on the R&D work the biotech start­up is do­ing on al­losteric mod­u­la­tors with the $40 mil­lion cash it re­cent­ly raised. Mor­ri­son brings fresh ex­pe­ri­ence at the helm from Keryx and Tokai, both of which have since be­come blend­ed in­to new, merged en­ti­ties. Part­nered with No­var­tis, Ca­dent is work­ing on “both fla­vors of the NM­DA re­cep­tor” to treat both de­pres­sion and schiz­o­phre­nia, though its most ad­vanced pro­gram tar­gets es­sen­tial tremor.

→ Look­ing for some sta­bil­i­ty in the C-suite af­ter go­ing through two CEOs in less than a year, Abeona Ther­a­peu­tics has asked in­ter­im CEO João Sif­fert to as­sume the post per­ma­nent­ly. For­mer­ly of fel­low gene ther­a­py com­pa­ny Cere­gene, Sif­fert joined Abeona in 2018 as CMO and head of R&D, then soon be­gan to dou­ble as chief ex­ec­u­tive when then-CEO Carsten Thiel got boot­ed six months in­to the job due to mis­con­duct. Sif­fert’s ex­pe­ri­ence on the board of AveX­is, the com­pa­ny says, po­si­tions him well for guid­ing the com­pa­ny in both the clin­ic and man­u­fac­tur­ing fa­cil­i­ty.

→ Over a 13-year ca­reer as a biotech an­a­lyst at Piper Jaf­fray, Cowen and Bank of Amer­i­ca Mer­rill Lynch, Rachel McMinn learned a lot about the in­dus­try and be­gan to won­der if she should be the one run­ning the com­pa­ny rather than just giv­ing ad­vice. Af­ter a short stint as chief busi­ness and strat­e­gy of­fi­cer at In­ter­cept, she’s ready to make the jump with the for­mal launch of a new biotech of her own. McMinn and the 20 staffers at New York-based Neu­ro­gene are tack­ling rare neu­ro­log­i­cal con­di­tions with a pipeline of gene ther­a­pies us­ing AAV tech.

Catal­ent $CTLT has pro­mot­ed Alessan­dro Masel­li to pres­i­dent and COO. For­mer­ly the SVP of glob­al op­er­a­tions, Masel­li will now over­see in­te­gra­tion of the com­pa­ny’s con­tract re­search ser­vice of­fer­ings — with a re­cent ac­qui­si­tion of Ju­niper Phar­ma — and take the bur­den of run­ning the day-to-day op­er­a­tions off CEO John Chimin­s­ki’s shoul­ders.

→ Fol­low­ing its peers in em­brac­ing dig­i­tal med­i­cine, France’s Sanofi said its chief med­ical of­fi­cer Ameet Nath­wani would al­so serve as the com­pa­ny’s first chief dig­i­tal of­fi­cer. Nath­wani, who was hired in 2016, is now al­so charged with in­te­grat­ing Sanofi’s ar­se­nal of med­i­cines with dig­i­tal tech­nolo­gies and ink­ing dig­i­tal part­ner­ships. Last year, Pfiz­er and Mer­ck named their CDOs, while No­var­tis and GSK an­nounced sim­i­lar ap­point­ments in 2017.

Gail McIn­tyre

→ Hav­ing man­aged Ar­a­vive’s $AR­AV R&D op­er­a­tions in Hous­ton for the past cou­ple of years, Gail McIn­tyre has earned a seat on the ex­ec­u­tive team as CSO. She will con­tin­ue to shep­herd the biotech’s can­cer ther­a­pies, one of which is now in Phase Ib, through lead op­ti­miza­tion and ear­ly de­vel­op­ment to the clin­ic.

Sam Wak­sal’s Kad­mon $KDMN has tapped one of its di­rec­tors to lead its fi­nance or­ga­ni­za­tion as CFO. Steven Mee­han, a for­mer in­vest­ment banker, brings both a deep un­der­stand­ing of the Kad­mon’s in­flam­ma­to­ry and fi­brot­ic dis­ease pipeline and “ex­pe­ri­ence in M&A, fi­nan­cial plan­ning and cap­i­tal rais­ing,” the com­pa­ny says.

→ T cell im­munother­a­py de­vel­op­er Medi­gene has con­vinced sea­soned in­vest­ment banker Ax­el-Sven Malkomes to jump back in­to biotech. In the dual role of chief fi­nan­cial of­fi­cer and chief busi­ness de­vel­op­ment of­fi­cer, Malkomes will have broad au­thor­i­ty over fi­nance, BD, le­gal af­fairs, IT and com­mer­cial op­er­a­tions from his of­fice in Mu­nich. Pre­vi­ous­ly, he led strat­e­gy plan­ning and M&D for Mer­ck KGaA.

Achilles Ther­a­peu­tics has poached Roche vet Markus Dan­gl from fel­low can­cer im­munother­a­py de­vel­op­er Medi­gene. The CSO ap­point­ment will trig­ger a move from Ger­many to the UK for Dan­gl, who’s been tasked with steer­ing the smooth en­try of two lead neoanti­gen pro­grams to the clin­ic — one in non-small cell lung can­cer and an­oth­er in melanoma.

→ As Achillion $ACHN plans for late-stage de­vel­op­ment and po­ten­tial com­mer­cial­iza­tion — de­spite re­cent­ly drop­ping a lead pro­gram — it has el­e­vat­ed for­mer cap­i­tal mar­kets banker Bri­an Di Do­na­to to CFO, months af­ter he joined the com­pa­ny.

→ Ready to em­bark on the clin­i­cal part of its T cell ther­a­py jour­ney, Eu­re­ka Ther­a­peu­tics has hired Hanzhong Li to help en­gage the fi­nan­cial com­mu­ni­ty. Li, whose of­fi­cial ti­tle will be SVP of cor­po­rate de­vel­op­ment, was CFO of Chi­na’s As­cen­t­age Phar­ma fol­low­ing stints as a strat­e­gy di­rec­tor at Bay­er and an an­a­lyst at Mor­gan Stan­ley.

→ Four for­mer FDA of­fi­cials have joined Parex­el’s reg­u­la­to­ry con­sult­ing team, in­clud­ing Kurt Bror­son, a 26-year agency vet­er­an steeped in chem­istry, man­u­fac­tur­ing and con­trols re­view for CDER; Changt­ing Hau­den­schild, who pri­mar­i­ly worked on clin­i­cal safe­ty and ef­fi­ca­cy as well as bio­mark­ers at CBER; cell and gene ther­a­py ex­pert Mo­ham­mad Hei­daran; and Mwan­go Kasho­ki, who brings per­spec­tive on post-ap­proval safe­ty re­quire­ments.

→ Not­ting­ham, UK-based pre­clin­i­cal ser­vice provider Syna­ture Dis­cov­ery has re­cruit­ed Al­lan Jor­dan from Can­cer Re­search UK to di­rect its on­col­o­gy drug dis­cov­ery arm. He will be joined by De­loitte vet Louisa Jordi­son, Syna­ture’s first di­rec­tor of strat­e­gy plan­ning.

With con­tri­bu­tion from John Car­roll.

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.