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.

“There were so many times where I would be puz­zled at the course of de­vel­op­ment,” Ar­faei told End­points News. “More re­cent­ly what a lot of com­pa­nies would do is seek out my guid­ance and pri­or­i­tize their projects ac­cord­ing­ly. 

“And that’s when I re­al­ized, maybe I should get in­volved at these com­pa­nies at an ear­li­er stage.”

Ar­faei will now join life sci­ences ven­ture firm Pap­pas Cap­i­tal as a part­ner, where he will work on iden­ti­fy­ing com­pa­nies and en­sur­ing those ques­tions have good an­swers from an ear­ly stage. He said his role will be to con­vert the sci­ence to num­bers and un­der­stand the risk-re­ward. 

Pap­pas’s re­cent suc­cess­es in­clude the mi­graine drug Colu­cid and the neu­ro start­up Af­fer­ent Phar­ma­ceu­ti­cals. Ar­faei said he al­ready sees one prospect for a treat­ment of a sys­temic dis­ease with­out good op­tions that has stymied the larg­er com­pa­nies. 

“I don’t want to call it a holy grail, but cer­tain­ly we do see in­vest­ment op­por­tu­ni­ties,” he said. 

Dis­cussing the in­creased rev­enue stress in the in­dus­try and pric­ing pres­sure from law­mak­ers and pres­i­den­tial can­di­dates — briefly on dis­play again at last night’s De­mo­c­ra­t­ic de­bate — Ar­faei in­di­cat­ed his role in the com­pa­ny will dove­tail with in­dus­try trends. He ar­gued those two fac­tors will push the in­dus­try to find drugs that have good “val­ue” for the in­dus­try and pa­tients. Which is the kind of dis­cern­ing stance he will be tak­ing as an in­vestor.

Those fac­tors, he said, would com­pound with the in­dus­try’s grow­ing un­der­stand­ing of the mol­e­c­u­lar caus­es of dis­ease to make treat­ment more ef­fi­cient. 

“With the greater em­pha­sis on the cost — hope­ful­ly with the greater em­pha­sis on cost — there should be greater fo­cus on drugs that meet un­met needs and specif­i­cal­ly low­er the over­all cost bur­den for so­ci­ety,” Ar­faei said. 

Of course, that leaves open ques­tions about drugs that meet un­met needs but don’t nec­es­sar­i­ly low­er the over­all cost bur­den and it may not quite square with rhetoric from the White House and the cam­paign stage fo­cused pri­mar­i­ly on the stick­er price. 

By Ja­son Mast


Klaus Hen­ning Jensen Sanofi

→ Swiss-based Vi­for Phar­ma — the com­pa­ny that paid $1.5 bil­lion back in 2016 for Re­lyp­sa — has wooed Sanofi ex­ec Klaus Hen­ning Jensen as CMO. Jensen was the glob­al ther­a­peu­tic area head at Sanofi be­fore his switch. Pri­or to that, he held sev­er­al roles at No­vo Nordisk. In ad­di­tion, the com­pa­ny an­nounced the de­par­ture of chief com­mer­cial of­fi­cer Dario Ek­lund, who will leave by the end of Sep­tem­ber for oth­er op­por­tu­ni­ties. The com­pa­ny has ini­ti­at­ed a search for a suc­ces­sor. 

 

A week af­ter Gen­fit CEO Jean-François Mouney hand­ed the reins to his suc­ces­sor Pas­cal Prignet, the com­pa­ny has an­nounced that Car­ol Ad­dy is set to join as CMO. Ad­dy most re­cent­ly served in the same role at Mer­ck sub­sidiary Health Man­age­ment Re­sources and as the as­so­ciate di­rec­tor, di­rec­tor and se­nior prin­ci­pal sci­en­tist at Mer­ck Re­search Lab­o­ra­to­ries

Brain­Storm — a de­vel­op­er of au­tol­o­gous adult stem cell ther­a­peu­tics for neu­rode­gen­er­a­tive dis­eases — has wel­comed Pree­tam Shah as CFO. Shah was the di­rec­tor of health­care in­vest­ment bank­ing at Bar­clays Cap­i­tal, where he was in­volved in clos­ing more than $3.5 bil­lion in M&A and eq­ui­ty trans­ac­tions. Pri­or to that, Shah served as vice pres­i­dent of health­care in­vest­ment and bank­ing at Canac­cord Ge­nu­ity and held a stint at Re­liance Cap­i­tal USA Ven­tures. Shah found­ed and served as the man­ag­ing di­rec­tor of health­care fi­nan­cial con­sult­ing firm Sais­ar­va

Ay­ala Phar­ma­ceu­ti­cals brings on Gary Gor­don as the com­pa­ny’s CMO, just as their lead prod­uct can­di­date, AL101 — a gam­ma sec­re­tase in­hibitor — goes through Phase II for ade­noid cys­tic car­ci­no­ma pa­tients with tu­mor-bear­ing Notch ac­ti­vat­ing mu­ta­tions. Gor­don joins from a stint at Ab­b­Vie as vice pres­i­dent of on­col­o­gy de­vel­op­ment. His oth­er roles in­clude serv­ing at Ab­bott Lab­o­ra­to­ries and as CSO and vice pres­i­dent of clin­i­cal af­fairs at Ova­tion Phar­ma­ceu­ti­cals.

Bio­gen vet Jane Rhodes has joined Verge Ge­nomics — a com­pa­ny fo­cused on the de­vel­op­ment of new drugs for CNS dis­eases — as CBO af­ter a stint as vice pres­i­dent of busi­ness de­vel­op­ment and cor­po­rate strat­e­gy at FOR­MA Ther­a­peu­tics. While at Bio­gen, Rhodes found­ed the Val­ue Based Med­i­cine (VBM) In­no­va­tion Hub. Rhodes al­so co-found­ed soft­ware de­vel­op­ment com­pa­ny Qr8 Health

Xen­cor — best known for its bis­pe­cif­ic an­ti­bod­ies — has ap­point­ed Celia Eck­ert as vice pres­i­dent, gen­er­al coun­sel and cor­po­rate sec­re­tary of the com­pa­ny. Eck­ert joins the com­pa­ny from Syn­thet­ic Ge­nomics, where she served as vice pres­i­dent, cor­po­rate le­gal. Pri­or to that, she held stints at Se­quenom, Prometheus Lab­o­ra­to­ries and Pills­bury Winthrop Shaw Pittman and Jones Day

Ur­vashi Pa­tel Wind­MIL Ther­a­peu­tics

Wind­MIL Ther­a­peu­tics has reeled in Ur­vashi Pa­tel as vice pres­i­dent of reg­u­la­to­ry and qual­i­ty sys­tems, bol­ster­ing their ef­fort to ad­vance mar­row-in­fil­trat­ing lym­pho­cytes for can­cer im­munother­a­py. Most re­cent­ly, Pa­tel served as se­nior di­rec­tor, reg­u­la­to­ry af­fairs at Pre­ci­sion for Med­i­cine and held roles at Janssen and Elan Phar­ma­ceu­ti­cals

David Ep­stein-led can­cer start­up Black Di­a­mond Ther­a­peu­tics has made the ad­di­tion of Thomas (Tom­my) Leggett as CFO. Leggett joins the com­pa­ny af­ter hold­ing the same po­si­tion at Ax­cel­la Health, where he helped in rais­ing $156 mil­lion across three fi­nanc­ings. Pri­or to his time at Ax­cel­la, Leggett was trea­sur­er and head of busi­ness de­vel­op­ment fi­nance at Pur­due Phar­ma. Leggett’s oth­er stints in­clude serv­ing as an in­vest­ment banker for JP Mor­gan Se­cu­ri­ties, Lazard Frères & Com­pa­ny and UBS Se­cu­ri­ties

Thomas Leggett Black Di­a­mond

Onc­ter­nal Ther­a­peu­tics has wel­comed Gun­nar Kauf­mann as CSO and Ig­or Bilin­sky as CBO. Kauff­man comes on board af­ter a stint as SVP, im­munother­a­py, head of re­search and glob­al part­ner­ships at Sor­ren­to Ther­a­peu­tics. He was pre­vi­ous­ly a fac­ul­ty mem­ber at Scripps Re­search and still serves as ad­junct as­sis­tant pro­fes­sor in the de­part­ments of chem­istry and im­munol­o­gy and mi­cro­bial sci­ence. Bilin­sky was COO of Am­pliPhi Bio­sciences Cor­po­ra­tion be­fore tak­ing on this new role. His ca­reer has al­so spanned Igny­ta, Vi­cal, Halozyme Ther­a­peu­tics and An­dro­clus.

→ Swedish com­pa­ny Be­ac­ti­ca Ther­a­peu­tics made sev­er­al new ad­di­tions to its team. Vendela Par­row, the new head of pre­clin­i­cal de­vel­op­ment, brings ex­pe­ri­ence from pre­vi­ous po­si­tions at Akin­ion Phar­ma­ceu­ti­cals, Ax­e­lar and Phar­ma­cia Biovit­rum. Join­ing the board of di­rec­tors are Maarten de Chateau, cur­rent CEO of Six­era Phar­ma and Buz­zard Phar­ma­ceu­ti­cals, and Håkan Wick­holm, present­ly a board mem­ber of Gen­o­vis. Fi­nal­ly, Jo­han Har­men­berg, CMO of On­copep­tides, has been brought on as a clin­i­cal ad­vi­sor. 

MaaT Phar­ma — fo­cused on mi­cro­bio­me-based drug prod­ucts — an­nounced two new ap­point­ments: Jean-Marc Re­nard as CBO and Em­manuel Pre­stat as com­pu­ta­tion­al bi­ol­o­gy man­ag­er. Re­nard was pre­vi­ous­ly the vice pres­i­dent of cor­po­rate de­vel­op­ment at Sanofi Pas­teur, where he was re­spon­si­ble for the $750 mil­lion ac­qui­si­tion of Pro­tein Sci­ences. Pre­stat was the as­so­ciate di­rec­tor of re­search and de­vel­op­ment at HalioDx and held a stint with­in the in vit­ro di­ag­nos­tics de­part­ment at QI­A­GEN.

Joel Smith has joined as the gen­er­al coun­sel and EVP of cor­po­rate de­vel­op­ment of Epic Sci­ences — a com­pa­ny part­nered with Ge­nom­ic Health to com­mer­cial­ize the On­co­type DX AR-V7 nu­cle­us de­tect test. Smith comes from Qual­comm Life, where he served as man­ag­ing coun­sel of the com­pa­ny. He has al­so held stints as gen­er­al coun­sel at BioQ, Tri­ad Ther­a­peu­tics and Sien­tra

Pe­ter-Paul Tak-led gut-fo­cused com­pa­ny Kin­tai Ther­a­peu­tics has ush­ered in Mark Nut­tall as CBO. Nut­tall hails from Kymera Ther­a­peu­tics, where he served in the same role. His pre­vi­ous stints in­clude roles at Sanofi Gen­zyme, John­son & John­son, GSK and As­traZeneca

→ Copen­hagen, Den­mark-based Xel­lia Phar­ma­ceu­ti­cals has ap­point­ed Pe­ter Bak­er as CMO, Xel­lia North Amer­i­ca. Bak­er brings ex­pe­ri­ence from his time at Ab­bott Lab­o­ra­to­ries, Hos­pi­ra and Pfiz­er. His ap­point­ment comes at a time when the com­pa­ny is prepar­ing to ex­pand its pro­pri­etary liq­uid fran­chise, which in­cludes the first and on­ly room tem­per­a­ture Van­comycin in­jec­tion pre­mix. 

→ At the end of Au­gust, Soli­genix an­nounced that it had up­dat­ed the late-stage pro­gram for its ex­per­i­men­tal drug, SGX942, by in­creas­ing en­roll­ment by 70 pa­tients to 260 sub­jects. Now, Jonathan Guar­i­no has hopped on board to Soli­genix as their se­nior vice pres­i­dent and CFO — suc­ceed­ing Karen Krume­ich, who will be pur­su­ing new op­por­tu­ni­ties. Guar­i­no most re­cent­ly served as cor­po­rate con­troller for He­p­i­on Phar­ma­ceu­ti­cals and held stints at Co­v­ance, Black­Rock and Barnes & No­ble

Pe­ter Butera PR

CuraSen Ther­a­peu­tics — a com­pa­ny kick­start­ed by Kath­leen Sere­da Glaub and An­tho­ny Ford out of the lab of Stan­ford’s Mehrdad Sham­loo, fo­cused on the treat­ment of neu­rode­gen­er­a­tive dis­eases, such as Parkin­son’s and Alzheimer’s — has re­cruit­ed Pe­ter Butera to the team as SVP, op­er­a­tions. Be­fore CuraSen, Butera ran the bradan­i­cline pro­gram in chron­ic cough through Phase II at At­ten­ua as their vice pres­i­dent of clin­i­cal op­er­a­tions. Butera al­so held the same role at Af­fer­ent (be­fore its $1.25 bil­lion ac­qui­si­tion by Mer­ck) and Pain Ther­a­peu­tics.  

→ Hav­ing plot­ted com­mer­cial plans at In­ter­cept Phar­ma for the past five years, Kei­th White is bring­ing his mar­ket ac­cess acu­men to Cor­bus. As it en­ters the fi­nal reg­u­la­to­ry stretch with its lead drug, lenaba­sum, Cor­bus is prepar­ing for an in­ti­tal launch in sys­temic scle­ro­sis, close­ly fol­lowed by a pro­gram in der­mato­myosi­tis.

CRO PHAS­TAR has named Jen­nifer Brad­ford as the lead to the com­pa­ny’s da­ta sci­ence group — which is fo­cused on ap­ply­ing AI and ma­chine learn­ing to max­i­mize the val­ue of clin­i­cal tri­al da­ta. Brad­ford’s pre­vi­ous stints in­clude roles at As­traZeneca and Can­cer Re­search UK.

Mar­tin Mack­ay, Stephen Uden and Jef­frey Fry­er have scooped up a for­mer col­league at Alex­ion to beef up the R&D team at Rally­bio, their rare dis­ease start­up. Dou­glas Sheri­dan was a co-in­ven­tor of five clin­i­cal drug can­di­dates, in­clud­ing Alex­ion’s lat­est block­buster hope­ful Ul­tomiris (ap­proved by the FDA in 2018). His lat­est ti­tle at Alex­ion was ex­ec­u­tive di­rec­tor, glob­al pro­gram team leader.

→ For nine months, Tony Coles has been watch­ing close­ly as Adam Kop­pel and Bain’s life sci­ences team built Cerev­el from the ground up, of­fer­ing in­sights in­to its neu­ro­science pur­suit as ex­ec­u­tive chair­man while stay­ing at the helm of his own biotech. But now that he has passed the reins at Yu­man­i­ty to Richard Pe­ters, Coles is com­plet­ing the flip — and the top team puz­zle — by tak­ing the chief ex­ec­u­tive role at Cerev­el.

Tony Coles Yu­man­i­ty

“I’m ex­cit­ed be­cause I get dou­ble the op­por­tu­ni­ty to play a role in two im­por­tant com­pa­nies,” Coles not­ed in an in­ter­view with End­points News.

Coles — a four-time CEO who had a no­table tenure at Onyx Phar­ma, a biotech that was ul­ti­mate­ly sold to Am­gen — has got­ten to know Bain well. 

Most re­cent­ly Or­ly Mis­han, a Bio­gen vet, moved from Bain to be­come chief busi­ness of­fi­cer, join­ing CSO John Renger (who cut his teeth at Mer­ck), CMO Ray Sanchez (Ot­su­ka vet), CFO Kathy Yi (from Sang­amo) and Ken Dipetro, chief hu­man re­sources of­fi­cer.

Coles is still in­volved in Yu­man­i­ty as ex­ec­u­tive chair­man and an in­vestor — an­oth­er part of his grand ef­fort to make a dent in what he calls the next fron­tier in med­i­cine.

Stu­art Levy, co-founder of Paratek Phar­ma­ceu­ti­cals, passed away last week.

“Stu­art was a dis­tin­guished physi­cian who was the fore­front of an­tibi­ot­ic de­vel­op­ment and a ded­i­cat­ed cham­pi­on for the pru­dent use of an­tibi­otics,” said Evan Loh, Paratek CEO. “More im­por­tant­ly, he was a dear friend and men­tor to so many and his pas­sion lives on in each of us as we work to con­tin­ue his mis­sion of com­bat­ing the dai­ly threat of life-threat­en­ing in­fec­tions. We will great­ly miss him.”

Levy co-found­ed Paratek more than 20 years ago along with Wal­ter Gilbert. He was in­stru­men­tal in the de­vel­op­ment of the com­pa­ny’s lead an­tibi­otics, Nuzyra and Seysara. Levy dis­cov­ered the ef­flux mech­a­nism for drug (tetra­cy­cline) re­sis­tance and was among the first sci­en­tists to doc­u­ment the trans­fer of re­sis­tant bac­te­ria from an­i­mals to farm­work­ers. His 1992 book, The An­tibi­ot­ic Para­dox: How Mir­a­cle Drugs Are De­stroy­ing the Mir­a­cle, has been cit­ed wide­ly and trans­lat­ed in­to four lan­guages.

The news comes a few weeks af­ter the com­pa­ny pub­lished pos­i­tive Phase III da­ta for Nuzyra for pa­tients with AB­SS­SI.

John Furey

Im­vax has wooed John Furey, for­mer COO of Spark Ther­a­peu­tics, to the helm as CEO and to its board of di­rec­tors. Furey suc­ceeds in­ter­im CEO David An­drews, the com­pa­ny’s co-founder and CMO. Dur­ing his time at Spark, Furey led the US launch of pi­o­neer­ing gene ther­a­py Lux­tur­na. Pri­or to Spark, Furey served as SCP and head of glob­al op­er­a­tions at Bax­al­ta. He al­so held a stint at Pfiz­er, where he ini­ti­at­ed the re­struc­tur­ing and di­vesti­ture of Bax­ter In­ter­na­tion­al’s vac­cines fran­chise to Pfiz­er.

In his new role, Furey will steer Philadel­phia-based Im­vax through a Phase II for its au­tol­o­gous tu­mor cell vac­cine for glioblas­toma mul­ti­forme, a no­to­ri­ous­ly hard-to-treat can­cer.

Lisa M. DeAn­ge­lis MSKCC

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 in­to the act­ing CMO role in the wake of Basel­ga’s de­par­ture.

→ Af­ter wel­com­ing J&J deal­mak­er Mar­i­anne De Backer to their team as BD chief a lit­tle more than a week ago, Bay­er an­nounced that it will be re­duc­ing the size of the com­pa­ny’s board of man­age­ment. Hart­mut Klusik and Ke­mal Ma­lik will be hit­ting the ex­it and the com­pa­ny doesn’t plan on re­tain­ing those po­si­tions — tak­ing the board from sev­en to five mem­bers.

Ac­cord­ing to the com­pa­ny, as of Jan­u­ary 1, 2020, the board of man­age­ment will con­sist of chair­man Wern­er Bau­mann, CFO Wolf­gang Nickl and di­vi­sion pres­i­dents Liam Con­don (Crop Sci­ence), Ste­fan Oel­rich (Phar­ma­ceu­ti­cals) and Heiko Schip­per (Con­sumer Health).

→ Months af­ter UK-based Mo­gri­fy re­lo­cat­ed to the Bio-In­no­va­tion Cen­tre at the Cam­bridge Sci­ence Park and added 15 new staff mem­bers to its sci­en­tif­ic and man­age­ment teams, the com­pa­ny has wooed a high-pro­file leader to chair their board. Jane Os­bourn, a bio­phar­ma vet, was vice pres­i­dent for re­search and de­vel­op­ment and site leader at Med­Im­mune (for­mer­ly Cam­bridge An­ti­body Tech­nol­o­gy). She is a rec­og­nized ex­pert in an­ti­body en­gi­neer­ing cred­it­ed for the dis­cov­ery and de­vel­op­ment of eight mar­ket­ed drugs, such as Hu­mi­ra and Benlysta.

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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Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation for a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month.

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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.

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.