Stag­gered by a se­ries of late-stage set­backs capped by the FDA’s re­fusal to ac­cept its ap­pli­ca­tion on their lead­ing late-stage drug and look­ing vul­ner­a­ble on its num­bers, Cel­gene CEO and chair­man Mark Alles is re­vamp­ing the lead­er­ship struc­ture at the wob­bly biotech.

Scott Smith

Num­ber one on the to-do list: Scott Smith is out as pres­i­dent and COO, with im­me­di­ate ef­fect. He’s not re­tir­ing or off in search of new op­por­tu­ni­ties. He’s just out.

The man­age­ment re­vamp will leave Alles in charge of every­thing from clin­i­cal de­vel­op­ment to reg­u­la­to­ry, the all-im­por­tant hema­tol­ogy and on­col­o­gy fran­chise as well as in­flam­ma­tion and im­munol­o­gy.

Mark Alles

Re­port­ing di­rect­ly to him: Nadim Ahmed, pres­i­dent, glob­al hema­tol­ogy and on­col­o­gy; Ter­rie Cur­ran, pres­i­dent, glob­al in­flam­ma­tion and im­munol­o­gy; Jay Back­strom, chief med­ical of­fi­cer and head of glob­al reg­u­la­to­ry af­fairs; and Joanne Beck, ex­ec­u­tive vice pres­i­dent, glob­al phar­ma­ceu­ti­cal de­vel­op­ment and op­er­a­tions.

And the re­or­ga­ni­za­tion ap­pears to still be un­der way. Jef­feries’ Michael Yee not­ed Mon­day night: “The com­pa­ny is re­or­ga­niz­ing its ex­ec­u­tive team in the mean­time, and we could hear sev­er­al hires/pro­mo­tions over the com­ing months.”

The move comes short­ly af­ter Bob Hug­in’s de­par­ture as ex­ec­u­tive chair­man of the com­pa­ny he ran to great ac­claim for years. But the ap­plause has qui­et­ed sig­nif­i­cant­ly over the past year. Cel­gene’s $710 mil­lion cash roll of the dice on the in­flam­ma­to­ry bow­el dis­ease drug mon­gersen (GED-301) came up snake eyes in Phase III last fall. Most re­cent­ly the FDA re­ject­ed Cel­gene’s ap­pli­ca­tion for ozan­i­mod, an em­bar­rass­ment for a com­pa­ny that prid­ed it­self on its abil­i­ty to ex­e­cute ef­fec­tive­ly.

That could have been for­giv­en eas­i­ly enough, but in­vestors have been alarmed over weak fi­nan­cials un­der­scor­ing the com­pa­ny’s ex­tra­or­di­nary de­pen­dence on Revlim­id and the big, reg­u­lar price hikes it needs to keep on top of the game. Revlim­id’s patent po­si­tion is al­so un­der as­sault.

Just week’s ago Baird’s Bri­an Sko­r­ney not­ed that re­peat­ed sna­fus have cre­at­ed a sit­u­a­tion where “in­vestors are hes­i­tant to get back in­to what was once biotech’s poster child for con­tin­ued growth and sol­id ex­e­cu­tion.”

Alles wants it all back, and he now has fi­nal re­spon­si­bil­i­ty for all of it.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Two small gene therapy makers and a biotech working on an investigational migraine drug have let employees go. The moves add to a broader year-long wave of layoffs that have sidelined thousands of workers in the industry.

Satsuma Pharmaceuticals said after Tuesday’s market close that it will lay off 36% of its workers, effective this Friday. The South San Francisco and Durham, NC biotech submitted its approval request to the FDA this month for a migraine drug, but Satsuma won’t be building a commercial team as it seeks an “established pharmaceutical company” to deliver STS101 to patients, should it get the green light. The company had 25 employees at the end of 2022.