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.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.