Ox­ford Bio­med­ica's next CEO to start in March; Kåre Schultz ready to wrap up Te­va tenure ear­ly

Frank Math­ias

→ Frank Math­ias is call­ing it quits as CEO of Ger­man CD­MO Rentschler Bio­phar­ma, mov­ing in­stead to UK gene and cell ther­a­py play­er Ox­ford Bio­med­ica in March 2023. At that time, he’ll al­so re­turn to the fa­mil­iar con­fines of the Rentschler su­per­vi­so­ry board, which he first joined in 2013 be­fore vault­ing to CEO three years lat­er. Ox­ford Bio­med­ica’s long­time CEO John Daw­son re­tired in Jan­u­ary, and in­ter­im chief Roch Do­liveux will get to fo­cus sole­ly on his role as chair­man once Math­ias ar­rives.

As Rentschler ini­ti­ates the search for Math­ias’ re­place­ment, there’s been no short­age of new ap­point­ments here in the last year — and Chris­tiane Bardroff was just pro­mot­ed to COO last week.

Richard Fran­cis

Te­va is well ahead of sched­ule with its CEO tran­si­tion, get­ting a jump on ap­point­ing ex-San­doz chief Richard Fran­cis to take over for Kåre Schultz. The 61-year-old Schultz had orig­i­nal­ly planned to leave Te­va when his con­tract ex­pires in No­vem­ber 2023, but Fran­cis will start run­ning the show on Jan. 1 af­ter a mu­tu­al agree­ment to ac­cel­er­ate the timetable, End­points News’ Drew Arm­strong re­port­ed on Mon­day. Schultz has dealt with a glut of opi­oid set­tle­ments in his five-year tenure at Te­va along with the chal­lenges that have en­veloped the gener­ics land­scape. And Fran­cis knows that ter­ri­to­ry very well from his time at San­doz, which No­var­tis has fi­nal­ly de­cid­ed to spin off af­ter so much dither­ing that Fran­cis re­signed over the un­cer­tain fu­ture of the gener­ics di­vi­sion — in 2019. Since then, Fran­cis had been CEO of two com­pa­nies from the Syn­cona port­fo­lio: Pure­spring Ther­a­peu­tics and Force­field Ther­a­peu­tics.

“This is the right time for a tran­si­tion, and Richard’s proven track record in the in­dus­try makes him the right per­son to serve as Te­va’s next CEO,” Schultz said in a state­ment.

Luke De­vey

→ An­oth­er com­pa­ny from the Syn­cona uni­verse, Treg biotech Quell Ther­a­peu­tics, has tapped Luke De­vey as CMO. De­vey owns Big Phar­ma cre­den­tials from GSK, where he was se­nior di­rec­tor of trans­la­tion­al med­i­cine, and from J&J’s Janssen as head of trans­la­tion­al sci­ence at Janssen Im­munol­o­gy. In be­tween these stints, he was Cel­gene’s head of ear­ly dis­cov­ery bi­ol­o­gy, im­munol­o­gy & in­flam­ma­tion. We’re com­ing up on a year since Quell’s hefty $156 mil­lion Se­ries B as CEO Iain McGill hopes to pull ahead in a Treg bat­tle that in­volves Gen­tiBio, Aba­ta Ther­a­peu­tics and Jeff Blue­stone’s Sono­ma.

Daria Hazu­da

Mike Nal­ly’s crew at a mem­ber of the End­points 11’s Class of 2022, Flag­ship’s Gen­er­ate Bio­med­i­cines, is get­ting a bit larg­er with Daria Hazu­da as head of vac­cines and in­fec­tious dis­ease re­search and Lisa Wyman as SVP of tech­ni­cal op­er­a­tions. This marks the end of a 33-year re­la­tion­ship with Mer­ck for Hazu­da, who start­ed out as a se­nior re­search bio­chemist at the phar­ma gi­ant in 1989 and rose to VP of in­fec­tious dis­ease & vac­cines and CSO of the Cam­bridge, MA re­search site. Mean­while, Wyman had al­so been SVP of tech­ni­cal op­er­a­tions at Ac­celeron, one of Mer­ck’s stand­out M&A prizes. Us­ing ma­chine learn­ing to gen­er­ate a mul­ti­tude of drug can­di­dates, as the name im­plies, the biotech is awash with cash af­ter a $370 mil­lion Se­ries B a year ago.

Ja­copo An­dreose

Be­fore lin­ing up his first CEO job this week at Ital­ian brain health biotech An­geli­ni Phar­ma, Ja­copo An­dreose had been mak­ing the Big Phar­ma rounds too. An­dreose was re­cent­ly the SVP, in­ter­con­ti­nen­tal re­gion for Gilead, over­see­ing Asia, Latin Amer­i­ca, Mid­dle East, Africa and East­ern Eu­rope. He al­so split time be­tween Vi­iV Health­care (head of in­ter­na­tion­al) and par­ent com­pa­ny GSK (SVP, im­munol­o­gy and spe­cial­ty med­i­cine, among oth­er posts) in a sev­en-year pe­ri­od. Ovid and An­geli­ni teamed up on an An­gel­man syn­drome pact in Ju­ly 2020, but OV101 flamed out in Phase III; Ovid scrapped the pro­gram en­tire­ly, gut­ting its stock and spark­ing job cuts.

Jan­neke van der Kamp

→ On March 1, No­var­tis vet Jan­neke van der Kamp will suc­ceed Mark Fladrich as chief com­mer­cial of­fi­cer of Grü­nen­thal, the Ger­man com­pa­ny that picked up Bay­er’s low testos­terone med Nebido for $500 mil­lion in Ju­ly. In her 19 years with the Swiss phar­ma, van der Kamp took on such roles as glob­al neu­ro­sciences fran­chise head, glob­al head of prod­uct and port­fo­lio strat­e­gy and, since March 2019, head of the Eu­rope phar­ma re­gion. Fladrich came to Grü­nen­thal from As­traZeneca in 2017 and will be re­tir­ing on Feb. 28 af­ter a 35-year ca­reer.

Mark Smith

→ Ac­cord­ing to an SEC fil­ing, Mark Smith is step­ping down as CMO of Vista­gen on Dec. 1 but will still be part of the South San Fran­cis­co biotech’s clin­i­cal and reg­u­la­to­ry ad­vi­so­ry board. Vista­gen’s Phase III tri­al fail­ure with PH94B, its drug for so­cial anx­i­ety dis­or­der, sent the stock price $VT­GN in­to a freefall in late Ju­ly. Ear­li­er mid-stage stud­ies of AV-101 for de­pres­sion al­so didn’t pan out.

Pia Bau­mann

→ When we last saw Medi­vir in Peer Re­view, As­traZeneca vet Jens Lind­berg was set to take the CEO job. This time around, the Stock­holm can­cer biotech has turned to As­traZeneca for its new med­ical chief, bring­ing Pia Bau­mann in­to the fold. Bau­mann, the Big Phar­ma’s VP and glob­al med­ical fran­chise head for lung can­cer drug Tagris­so since Ju­ly 2020, has al­so been a med­ical af­fairs ex­ec with Take­da, In­cyte and Ari­ad Phar­ma­ceu­ti­cals.

Rick Klaus­ner

→ Con­cur­rent with Fog­Phar­ma’s $178 mil­lion Se­ries D round, the Greg Ver­dine start­up has al­so added for­mer NCI chief Rick Klaus­ner to the board of di­rec­tors. Al­tos Labs, Klaus­ner’s an­ti-ag­ing play led by ex-GSK R&D chief Hal Bar­ron, is an­oth­er hon­oree from this year’s End­points 11. Ver­dine has al­so been ap­point­ed chair­man of Fog­Phar­ma, which is shoot­ing for a mid-2023 IND sub­mis­sion for its lead as­set FOG-001, a TCF-block­ing β-catenin in­hibitor.

Bob Langer

→ We’re not done with the big names: Late last week, MIT’s Bob Langer was named chair­man of the sci­en­tif­ic ad­vi­so­ry board for Nat­ick, MA-based Al­lu­ri­on, the de­vel­op­er of a gas­tric bal­loon pill to treat obe­si­ty. Langer has found­ed or co-found­ed “prob­a­bly close to 40 com­pa­nies” by his count, with Mod­er­na top­ping the list. “Al­lu­ri­on has clear­ly demon­strat­ed that its prod­uct is a game-chang­er for pa­tients and has the po­ten­tial to de­vel­op an ex­cit­ing pipeline of prod­ucts that ad­dress dif­fer­ent ap­pli­ca­tions,” Langer’s state­ment reads.

Sharath Hegde

We cov­ered Sharath Hegde’s ap­point­ment as CSO of Herophilus in May 2021, but he’s al­ready found his next land­ing spot as the chief sci­en­tist at Mon­tre­al-based drug dis­cov­ery shop Con­gru­ence Ther­a­peu­tics. Be­fore he took the Herophilus job, Hegde was the CSO at Re­cur­sion and spent two decades at Ther­a­vance Bio­phar­ma, be­com­ing head of re­search in 2016. One more note: Tanya Bor­suk has al­so joined Con­gru­ence as EVP, cor­po­rate and busi­ness de­vel­op­ment. Be­fore her re­cent gig as CBO of Sit­ryx Ther­a­peu­tics, Bor­suk was head of pipeline strat­e­gy and busi­ness de­vel­op­ment at the afore­men­tioned Gen­er­ate Bio­med­i­cines.

Scott Cur­ley

→ The last ap­point­ment news we heard from Amarin was back in June, when the com­pa­ny in­stalled Tom Reil­ly af­ter the res­ig­na­tion of CFO Michael Kalb and a 40% re­duc­tion of its work­force be­cause of flag­ging sales for Vas­cepa. Now, the com­pa­ny is once again bring­ing in some new tal­ent with the ap­point­ment of Scott Cur­ley as gen­er­al man­ag­er of UK and Ire­land — hop­ing to flesh out its team in the area to prep for the launch of Vas­cepa. Cur­ley brings with him ex­pe­ri­ence from his time at As­traZeneca — which cul­mi­nat­ed in his role as gen­er­al man­ag­er of Hong Kong and Macau — and stints at GSK and SmithK­lineBeecham.

→ Now that Im­muno­Gen was grant­ed ac­cel­er­at­ed ap­proval by the FDA for its ovar­i­an can­cer drug, known as Ela­here, the ADC play­er has wel­comed Daniel Char to the team as chief le­gal of­fi­cer. Char held the role of as­so­ciate gen­er­al coun­sel dur­ing his 11 years at Bio­gen, and he spent the last four years as gen­er­al coun­sel and sec­re­tary for Evelo Bio­sciences, a Flag­ship biotech that’s look­ing for CEO Sim­ba Gill’s suc­ces­sor.

→ It’s cer­tain­ly been quite a week, giv­en the three days it’s been, for Paul Ren­nie. First, on Tues­day, he took over the reins at Par­a­digm Bio­phar­ma­ceu­ti­cals, the com­pa­ny he found­ed and chairs, af­ter Mar­co Polizzi an­nounced his ex­it. Then, ear­ly this morn­ing, Ren­nie nabbed the ti­tle of in­ter­im CEO over at Neu­ro­Sci­en­tif­ic Bio­phar­ma­ceu­ti­cals, a com­pa­ny he al­so chairs, three months af­ter the for­mer CEO re­signed.

Ian Smith

→ Soft­ware de­vel­op­er Optib­ri­um has named Ian Smith as chief tech­nol­o­gy of­fi­cer. Smith joins af­ter a stint as head of tech­nol­o­gy and de­liv­ery at Hx and has for­mer­ly held roles at Mer­ck, in­clud­ing di­rec­tor of re­searcher and de­vel­op­ment an­a­lyt­ics.

→ Two long­time ex­ecs at Area 23 are tack­ing on some new jobs to their cur­rent roles to in­clude the over­sight at IPG Health com­pa­ny Mc­Cann Health NY. Re­nee Mel­las has added on the ti­tle of Mc­Cann Health New York group pres­i­dent (tak­ing over from ex­it­ing Matt Sil­ver), while Tim Hawkey will al­so be chief cre­ative of­fi­cer. Mel­las has been with Area 23 for eight and a half years, while Hawkey joined 11 and a half years ago.

Stephen Her­mitage is skip­ping out of GSK and in­to Sai Life Sci­ences as its new VP, CMC. Her­mitage was with GSK for 24 years, cul­mi­nat­ing in his role as a de­part­ment head and a mem­ber of the glob­al chem­i­cal de­vel­op­ment lead­er­ship team.

Alessan­dra Ce­sano

Bob Dug­gan and his co-CEO Maky Zan­ganeh have ex­pand­ed the board of di­rec­tors once again at Sum­mit Ther­a­peu­tics, ap­point­ing Alessan­dra Ce­sano. The Bio­gen, Am­gen and GSK vet is the cur­rent CMO of Cana­di­an prostate can­cer biotech ES­SA Phar­ma. Robert Booth, one of Dug­gan’s board mem­bers from the Phar­ma­cyclics days, joined the board at Sum­mit in Oc­to­ber.

Sanofi I/O part­ner Ada­gene has elect­ed ex-Mer­ck chief strat­e­gy of­fi­cer Cuong Do to the board of di­rec­tors. Now the pres­i­dent and CEO at BioVie, Do was pres­i­dent of the glob­al strat­e­gy group at Sam­sung from 2015-20.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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