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.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.