In sud­den re­vamp, Cel­gene CEO Alles bids his COO good­bye and looks to re­gain con­fi­dence with man­age­ment shuf­fle

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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

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.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

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.”

Lay­offs hit pri­vate gene ther­a­py star­tups, mi­graine biotech Sat­suma as in­dus­try squeeze doesn’t let up

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.