Alex­ion's Hantson poach­es Bio­gen CFO Clan­cy as buzz of a loom­ing pipeline shake­up heats up

Paul Clan­cy

You can count one more top ex­ec at Bio­gen $BI­IB out the ex­it as new CEO Michel Vounatsos builds his team at the big biotech. And the de­part­ing ex­ec is head­ed straight to Alex­ion $ALXN, where Lud­wig Hantson has been build­ing his own team with an eye to strip­ping the pipeline ahead of a planned re­fur­bish­ment.

This time the ex­ec on the move is Paul Clan­cy, CFO at Bio­gen dur­ing the last event­ful decade at the big biotech.

Clan­cy sur­vived the bumpy de­par­ture of Jim Mullen in 2010 and helped steer the com­pa­ny as it launched a megablock­buster flag­ship drug in Tec­fidera un­der then CEO George Scan­gos.

Now Clan­cy is tak­ing on the top fi­nance job at Alex­ion at a time Hantson has gut­ted the old crew and brought in a whole new bunch to steer a dif­fer­ent course. Just a few weeks ago Hantson saw off R&D chief Mar­tin Mack­ay as well as CFO David An­der­son, who had been in that job on­ly six months. Clare Carmichael, the head of hu­man re­sources, left June 1 along with chief com­mer­cial of­fi­cer Carsten Thiel.

Bio­gen’s loss is Alex­ion’s gain. Bio­gen saw its shares drop 3% Wednes­day morn­ing, while Alex­ion stock surged 7%.

Alex­ion has un­der­gone a brain trans­plant af­ter the for­mer CEO and CFO came un­der scruti­ny for the way the com­pa­ny was push­ing ear­ly sales of Soliris to meet its num­bers. Now Hantson is al­so mak­ing it clear that the house clean­ing in the ex­ec­u­tive suite will be fol­lowed by a cleanup in R&D as well.

Lud­wig Hantson

Hantson — who has been open­ly com­plain­ing about the state of af­fairs at Alex­ion — re­port­ed­ly turned up at the Gold­man Sachs Health­care Con­fer­ence yes­ter­day say­ing he was think­ing of writ­ing off Kanu­ma, which quick­ly made the rounds on Twit­ter. Alex­ion ac­quired Kanu­ma in an $8.4 bil­lion buy­out of Synage­va and has lit­tle to show for it as sales fiz­zled.

ALXN1210 — an an­ti-C5 an­ti­body that in­hibits ter­mi­nal com­ple­ment for pa­tients with parox­ys­mal noc­tur­nal he­mo­glo­bin­uria (PNH) — was about the on­ly ex­per­i­men­tal prod­uct that earned much re­spect from Hantson. Hantson al­so re­cruit­ed his old R&D chief at Bax­al­ta, John Orloff, to helm the re­search crew as the com­pa­ny dumps what it doesn’t like and starts to re­tune the pipeline, just a few years be­fore its main­stay drug Soliris los­es patent pro­tec­tion in Eu­rope and the US in 2020 and 2021.

Hantson and Alex­ion, and now Clan­cy, don’t have much time if they want to turn the com­pa­ny around be­fore biosim­i­lars start to carve up its fran­chise.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

Genen­tech to halt com­mer­cial man­u­fac­tur­ing in Cal­i­for­nia HQ, with lay­offs at­tached

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate its commercial manufacturing operations from its South San Francisco headquarters said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech will produce medicines at its new clinical supply center, which opened in South San Francisco last year while many of its commercial products will be made at other production sites or by contract manufacturers.

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