Am­gen vet Marc de Garidel takes the helm at Cor­vidia; Pe­ter Green­leaf lands next CEO job at Cere­cor; Ed­ward Gu­daitis tapped to lead Acerus

Am­gen vet Marc de Garidel is tak­ing the helm at Cor­vidia Ther­a­peu­tics as the biotech wraps up a Phase II tri­al of its per­son­al­ized ther­a­py for chron­ic kid­ney dis­ease. Michael David­son, the found­ing CEO who de­signed the strat­e­gy to go af­ter small, ge­net­i­cal­ly de­fined pa­tient pop­u­la­tions, will re­main in the C-suite but fo­cus on the sci­ence. The Waltham, MA-based com­pa­ny may have launched less than two years ago, but it’s al­ready think­ing about its fu­ture com­mer­cial op­er­a­tions. De Garidel is ex­pect­ed to build the com­pa­ny much like how he helped grow Ipsen’s US op­er­a­tions as CEO.

Pe­ter Green­leaf

Pe­ter Green­leaf has found his next CEO job af­ter Su­cam­po Phar­ma’s ac­qui­si­tion by Mallinck­rodt — and he didn’t have to look far. He will have a new role at Cere­cor $CERC, where he’s been a di­rec­tor since last May. The Bal­ti­more biotech has large­ly re­cov­ered from a slump in­duced by a key mid-stage fail­ure, seal­ing a li­cens­ing deal with J&J for a de­pres­sion drug along the way. Green­leaf, a two-time CEO who’s served as pres­i­dent at As­traZeneca’s Med­Im­mune, sig­naled that he would fo­cus on grow­ing the pe­di­atric busi­ness and push­ing Cere­cor’s cen­tral ner­vous sys­tem drugs in or­phan and spe­cial­ty in­di­ca­tions. “Cere­cor is ex­pe­ri­enc­ing a time of rapid growth and I in­tend to in­te­grate its base busi­ness­es while build­ing the peo­ple, process­es, and cul­ture nec­es­sary to suc­ceed in to­day’s phar­ma­ceu­ti­cal in­dus­try,” he said. His ap­point­ment co­in­cides with the de­par­ture of Robert Mosca­to, who re­signed af­ter five months as pres­i­dent and COO.

→ Af­ter a CEO stint at out­sourc­ing firm En­zy­motec, Erez Is­raeli is jump­ing back in­to the gener­ic drug busi­ness at In­dia’s Dr Red­dy’s Lab­o­ra­to­ries. He suc­ceeds re­tir­ing COO Ab­hi­jit Mukher­jee, but will have the ad­di­tion­al role as glob­al head of gener­ic and phar­ma­ceu­ti­cal ser­vices and ac­tive in­gre­di­ents, based out of Hy­der­abad. That fits right in­to his back­ground — he spent 23 years at Te­va, work­ing his way through var­i­ous de­part­ments in­clud­ing Asia op­er­a­tions, North Amer­i­ca mar­ket­ing and sales, and glob­al qual­i­ty.

→ Fol­low­ing a five-month stint with­out a per­ma­nent CEO in place af­ter the for­mer chief ex­ec­u­tive Tom Rossi left, Acerus Phar­ma­ceu­ti­cals has fi­nal­ly filled the post. The com­pa­ny hired Ed­ward Gu­daitis, who most re­cent­ly served at Al­ler­gan as VP and coun­try man­ag­er, Cana­da. Gu­daitis is like­ly bet­ter known for his role as gen­er­al man­ag­er for Gilead Sci­ences Cana­da, where he worked for over a decade. Gu­daitis will take on two roles — pres­i­dent and CEO — at Acerus as of May 1. Acerus’ in­ter­im CEO Luc Mainville is stay­ing on to show Gu­daitis the ropes, and then will tran­si­tion back to his post on the com­pa­ny’s board.

→ Long­time CFO William O’Con­nor is re­tir­ing from The Med­i­cines Com­pa­ny, so an­oth­er ex­pe­ri­enced fi­nan­cial ex­ec, Christo­pher Vi­si­oli has been pro­mot­ed to fill his seat. Dur­ing his 13-year tenure, start­ing out as the chief ac­count­ing of­fi­cer, O’Con­nor has helped the com­pa­ny ex­e­cute its bot­tom-down re­struc­tur­ing, shed­ding non-core busi­ness­es and prod­ucts in­clud­ing the car­dio­vas­cu­lar and in­fec­tious dis­ease units. He will spend the rest of the year ad­vis­ing Vi­si­oli in clos­ing out these ear­li­er de­ci­sions — de­ci­sions that Vi­si­oli like­ly played a part in as SVP of fi­nan­cial strat­e­gy.

→ Can­cer im­munother­a­py play­er Com­pu­gen $CGEN has poached Hen­ry Ade­woye from Gilead to be its first CMO. The biotech, with its R&D fa­cil­i­ties in both Tel Aviv and South San Fran­cis­co, has been in the busi­ness of drug dis­cov­ery for a while. But now that it’s look­ing clin­i­cal test­ing for its own pipeline, ex­ecs de­cid­ed they could use some help from some­one like Ade­woye, who’s steered drugs through dif­fer­ent stages of tri­als. Be­fore join­ing Gilead, where he even­tu­al­ly be­came clin­i­cal di­rec­tor in on­col­o­gy clin­i­cal re­search, he held sim­i­lar roles at Am­gen. His first as­sign­ment: ini­ti­ate the first hu­man test­ing of COM701, which tar­gets the nov­el im­mune check­point PVRIG, lat­er in 2018.

→ Hav­ing ob­served Be­yond­Spring $BYSI as an in­vestor for two years, Ed­ward Dongheng Liu is join­ing the team as CFO. Like Be­yond­Spring, Liu — a for­mer JP Mor­gan and Jef­feries banker — has back­ground in both the US and Chi­na go­ing back to his school days. The New York-based com­pa­ny plans to sub­mit NDAs for its lead can­cer drug plinab­u­lin in Chi­na around the turn of the year, and in the US short­ly af­ter.

→ Fol­low­ing the launch of a new fa­cil­i­ty for its con­tract man­u­fac­tur­ing and de­vel­op­ment busi­ness, LakePhar­ma has re­cruit­ed David Boyle to be its CFO. Boyle comes to the South San Fran­cis­co CRO from af­ter mul­ti­ple fi­nan­cial stints in small dis­cov­ery com­pa­nies, biotechs and a med­ical de­vice de­vel­op­er, in­clud­ing Ogenx Ther­a­peu­tics and Biono­vo.

CRISPR Ther­a­peu­tics $CR­SP has tapped Shel­by Walk­er to head in­tel­lec­tu­al prop­er­ty man­age­ment as chief le­gal of­fi­cer Tyler Dy­lan-Hyde re­tires. Con­sid­er­ing the bit­ter patent fights that char­ac­ter­ized ri­val­ries be­tween ear­ly play­ers in this gene-edit­ing field, the role car­ries spe­cial im­por­tance for the biotech. In Walk­er, the team gets some­one with ex­ten­sive IP ex­pe­ri­ence across ther­a­peu­tic ar­eas — fea­tur­ing roles at Dyax, No­vo Nordisk and Bio­gen.

→ Ger­man con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion Rentschler Bio­phar­ma has hired Thomas Rösch as VP of bio­phar­ma en­gi­neer­ing and tech­nol­o­gy. In his pre­vi­ous roles at Boehringer In­gel­heim, Rösch main­tained high-lev­el over­sight and man­age­ment of a num­ber of in­ter­na­tion­al pro­duc­tion sites. He is ex­pect­ed to chan­nel those 16 years of ex­pe­ri­ence in­to his new job, where he is tasked with en­hanc­ing sites and their ca­pac­i­ty.

Frances Duffy-War­ren

→ High­light­ing its am­bi­tions for its in-house pipeline, For­ma Ther­a­peu­tics has brought in Frances Duffy-War­ren to the ex­ec­u­tive team as head of reg­u­la­to­ry af­fairs. Com­ing from a decade-long run at Acte­lion, Duffy-War­ren has pre­vi­ous­ly li­aised with reg­u­la­tors on be­half of No­var­tis, As­traZeneca and San­doz. The wide range of ther­a­peu­tics ar­eas she’s dealt with like­ly pre­pared her move in­to For­ma, which has re­search and dis­cov­ery pro­grams in on­col­o­gy, in­flam­ma­tion & im­mu­ni­ty and neu­rode­gen­er­a­tion, among oth­er dis­eases.

→ Pur­due Phar­ma, a com­pa­ny best known for mak­ing Oxy­Con­tin, has cre­at­ed a new role – head of cor­po­rate so­cial re­spon­si­bil­i­ty. The com­pa­ny has moved Lisa Miller, who used to serve as Pur­due Phar­ma’s head of risk man­age­ment and mit­i­ga­tion, in­to the post. The com­pa­ny said the opi­oid cri­sis was spurring Pur­due to make cor­po­rate so­cial re­spon­si­bil­i­ty more of a pri­or­i­ty. “Our com­mit­ment to de­vote even greater re­sources to this area close­ly fol­lows our re­cent de­ci­sion to dis­con­tin­ue sales rep­re­sen­ta­tives’ pro­mo­tion of opi­oids to pre­scribers and speak­er pro­grams as­so­ci­at­ed with our opi­oid prod­ucts,” said Pur­due’s pres­i­dent and CEO Craig Lan­dau in a state­ment. In her new role, Miller will build on the com­pa­ny’s ex­ist­ing part­ner­ships and col­lab­o­ra­tions and move for­ward the com­pa­ny’s ef­forts to ad­dress the opi­oid cri­sis “be­yond pre­ven­tion and harm re­duc­tion in­to the ar­eas of treat­ment and re­cov­ery sup­port.”

Mark Day has wooed his for­mer Bris­tol-My­ers Squibb col­league Car­o­line Hill to run R&D for Bioa­sis, the brain can­cer and neu­rode­gen­er­a­tion biotech he be­gan to lead just a year ago. The new SVP has a broad man­date over the pipeline of drugs de­signed to be de­liv­ered across the blood-brain bar­ri­er, in­clud­ing time­lines, ven­dor man­age­ment, con­sul­ta­tion and up­dates to the board. While the com­pa­ny’s head­quar­ters is in Van­cou­ver, Hill will work out of its US of­fice in Guil­ford, CT.

→ With Cather­ine Wert­jes re­tir­ing from Astel­las, Tat­jana Dragov­ic got a pro­mo­tion to lead ethics and com­pli­ance for the com­pa­ny’s glob­al op­er­a­tions. Her new role gives her broad re­spon­si­bil­i­ty for the whole de­part­ment, where she’s spent a con­sid­er­able amount of time since join­ing the phar­ma’s le­gal team in 2007.

Be The Match Bio­Ther­a­pies has made three new ap­point­ments to bol­ster the busi­ness, clin­i­cal and op­er­a­tional sides of its cell ther­a­py ser­vices. Stem cell trans­plant physi­cian Steven Devine has come on board as med­ical di­rec­tor, join­ing the oth­er two old mem­bers. As VP of new busi­ness de­vel­op­ment and sales, Chris Mc­Clain will con­tin­ue to work with the BD team that he’s con­sult­ed for the past two years. Jamie Mar­go­lis has been giv­en the new ti­tle di­rec­tor of prod­uct de­vel­op­ment op­er­a­tions, fo­cused on prod­uct de­liv­ery to clients.

John Sa­ia is the new gen­er­al coun­sel at Acel­Rx $ACRX, a Red­wood City, CA-based biotech now hus­tling its pain med to the FDA for a sec­ond time.

Clin­i­pace World­wide has named Ian Fras­er VP of op­er­a­tions for Eu­rope and Mid­dle East, task­ing him with both lead­ing ex­ist­ing clin­i­cal op­er­a­tions and of­fer­ing up new CRO ser­vices in the re­gion.

Jen­nifer Doud­na — one of the trail­blaz­ers of the CRISPR/Cas9 tech — is now an ad­vis­er to Syn­thego in its quest to bring genome en­gi­neer­ing tools to aca­d­e­m­ic and in­dus­try re­searchers.

With con­tri­bu­tion by Brit­tany Meil­ing.
Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.