As­traZeneca vet Jen­nifer But­ler takes charge of In­nate Phar­ma's US biz; C4 raids NI­BR

→ France’s In­nate Phar­ma has wooed As­traZeneca vet Jen­nifer But­ler to lead the US op­er­a­tions it has set up af­ter ac­quir­ing Lu­mox­i­ti from the British drug­mak­er in a rich add-on col­lab­o­ra­tion deal. But­ler’s of­fi­cial ti­tle will be EVP and gen­er­al man­ag­er of In­nate Phar­ma US. Most re­cent­ly, she was chief busi­ness of­fi­cer, chief com­mer­cial of­fi­cer and head of US op­er­a­tions at Tes­sa Ther­a­peu­tics.

→ Af­ter cel­e­brat­ing the ap­proval of a Parkin­son’s ther­a­py he helped ac­quired for Acor­da Ther­a­peu­tics, chief busi­ness of­fi­cer An­drew Hind­man has de­cid­ed to step down. Hind­man, who joined Acor­da in 2014, is now “in­ter­est­ed in pur­su­ing op­por­tu­ni­ties in the wider bio­phar­ma in­dus­try,” CEO Ron Co­hen said. Over the next few tran­si­tion­ing months, he will con­tin­ue to help eval­u­ate ex-US com­mer­cial part­ner­ships for In­bri­ja as the com­pa­ny awaits a Eu­ro­pean reg­u­la­to­ry de­ci­sion.

→ C4 Ther­a­peu­tics has raid­ed the No­var­tis In­sti­tutes of Bio­med­ical Re­search for its chief med­ical of­fi­cer. The biotech re­port­ed to­day that it’s hired on Adam Crys­tal for the spot, fol­low­ing a stint as a se­nior di­rec­tor at NI­BR. C4 is one of sev­er­al biotechs work­ing on pro­tein de­graders, which has al­so been a keen in­ter­est of NI­BR chief Jay Brad­ner. “Dr. Crys­tal’s deep un­der­stand­ing of the sci­ence of tar­get­ed pro­tein degra­da­tion, cou­pled to his proven clin­i­cal lead­er­ship and un­der­stand­ing of the pa­tient com­mu­ni­ty, will be in­stru­men­tal to ad­vanc­ing C4T’s pipeline,” said Andy Phillips, the CEO of C4.

John Lea­man is quit­ting his job as CFO and head of cor­po­rate strat­e­gy at Se­lec­ta Bio, a year and a half af­ter join­ing the Wa­ter­town, MA-based biotech. His res­ig­na­tion comes in the wake of a re­vamp that claimed 36% of the staff — most of them work­ing on a now de­funct on­col­o­gy team — and pro­mot­ed a gout drug to the lead po­si­tion.

→ San Diego-based Escient has tapped William Hod­der as its chief busi­ness of­fi­cer, adding a sea­soned BD ex­ec and one-time en­tre­pre­neur to its start­up lead­er­ship team. Less than a year in­to its of­fi­cial ex­is­tence, the biotech is still busy trans­lat­ing in­sights on Mas-re­lat­ed G-pro­tein re­cep­tors to a new class of GCPR-tar­get­ed drugs, and Hod­der will play a hand in the plan­ning and grow­ing process, CEO Alain Baron said. Be­fore a re­cent run as a con­sul­tant, Hod­der has worked for Pro­tag­o­nist Ther­a­peu­tics and Fi­bro­Gen, as well as found­ing and lead­ing Tren­ovus.

In­cyte’s head of clin­i­cal de­vel­op­ment in Eu­rope has jumped ship to shape a nascent pipeline at iOnc­tura, a Mer­ck KGaA spin­out based in Gene­va. As CMO, Michael Lahn will lead first-in-hu­man stud­ies of the biotech’s next-gen PI3Kδ in­hibitor and po­ten­tial first-in-class au­to­tax­in (ATX) in­hibitor. Lahn, an alum­ni of As­traZeneca and Eli Lil­ly, will work close­ly with Zoë John­son, who’s re­cent­ly been pro­mot­ed to CSO.

→ Is­rael’s burn and wound man­age­ment biotech Medi­Wound is part­ing ways with CEO Gal Co­hen af­ter 12 years. Sharon Mal­ka, who helped steer the com­pa­ny to a 2014 Nas­daq de­but along­side Co­hen dur­ing this time as CFO and COO, is step­ping up to the role. Co­hen’s tenure was marked by Eu­rope and Is­rael ap­provals for Nexo­Brid, Medi­Wound’s flag­ship, non-sur­gi­cal prod­uct for burn treat­ment. Now fi­nanced un­der a con­tract with BAR­DA, the ther­a­py has com­plet­ed a sec­ond Phase III that will hope­ful­ly prop up the case for an FDA ap­proval — some­thing that Mal­ka will over­see while sup­port­ing an “on­go­ing strate­gic process.”

→ Or­phan drug de­vel­op­er Mi­no­ryx Ther­a­peu­tics has re­cruit­ed Di­di­er Le Nor­mand to be CFO of its op­er­a­tions across Eu­rope and the gen­er­al man­ag­er of a new­ly es­tab­lished Bel­gian sub­sidiary. The ap­point­ment adds an­oth­er C-suite role to Le Nor­mand’s re­sume, which has been packed with sim­i­lar roles in phar­ma and medtech com­pa­nies.

→ Biotech vet Tony Fior­i­no — per­haps best known as the for­mer CEO of Brain­storm Ther­a­peu­tics — is tak­ing up the CMO post at elec­tro­Core $ECOR as it seeks FDA clear­ance of its non-in­va­sive bio­elec­tron­ic va­gus nerve stim­u­la­tor gam­ma­Core. Com­ing from an in­ter­im CEO role at strug­gling Im­mune Phar­ma, he re­places Pe­ter Staats, who will be­come a se­nior ex­ec­u­tive ad­vis­er. Al­so join­ing the com­pa­ny: Phar­ma­copeia vet Bri­an Pos­ner, elec­tro­Core’s new CFO.

→ While re­searchers at Sang­amo Ther­a­peu­tics $SG­MO con­tin­ue to tweak its gene edit­ing tech for its lead rare dis­ease pro­grams, the biotech is beef­ing up its cell ther­a­py team to grow the CAR-Tregs port­fo­lio. Ja­son Fontenot will now lead that ef­fort, in­clud­ing a part­ner­ship with Sanofi and a pact with Gilead’s Kite for he­mo­glo­binopathies and can­cer re­spec­tive­ly. He comes to his new role of SVP, cell ther­a­py by way of Im­mu­soft, Juno and Bio­gen.

→ Ex­pe­ri­enced medtech ex­ec Kevin Kalish has been re­cruit­ed to lead the R&D ef­fort at En­Clear Ther­a­pies, a neu­rode­gen­er­a­tion-fo­cused start­up that’s just raised $2 mil­lion in seed fund­ing to take a de­vice-based amy­otroph­ic lat­er­al scle­ro­sis ther­a­py to the clin­ic in two years. De­vel­oped by Kevin Eggan of the Broad In­sti­tute, the treat­ment would re­move tox­ic pro­teins be­lieved to dri­ve the dis­ease.

Cold Spring Har­bor Lab’s Mick­ey At­w­al has teased on Twit­ter that he will “soon be join­ing Re­gen­eron to head their ma­chine learn­ing and mol­e­c­u­lar pro­fil­ing ef­forts.” Hav­ing re­searched the in­ter­sec­tion of pop­u­la­tion ge­net­ics, ma­chine learn­ing and can­cer bi­ol­o­gy, de­vel­op­ing math­e­mat­i­cal and com­pu­ta­tion­al tools, he’s mov­ing on­to a new po­si­tion with “di­rect trans­la­tion­al op­por­tu­ni­ties ahead,” At­w­al said.

Tri­umvi­ra Im­muno­log­ics has named Cyn­thia Moli­na as VP of reg­u­la­to­ry af­fairs to dri­ve sub­mis­sions and in­ter­ac­tions with health agen­cies around the world. Moli­na has been im­mersed in the T cell can­cer ther­a­py world while serv­ing in a sim­i­lar role at Hous­ton-based Cell Med­ica for the past six years.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.