Medi­vir taps ex-Aca­dia chief Uli Hack­sell as in­ter­im CEO; Mer­ck on­boards chief dig­i­tal of­fi­cer

Leone Pat­ter­son

→ Fol­low­ing a five-month search for a full-time chief ex­ec­u­tive, Ad­verum Biotech­nolo­gies $AD­VM has de­cid­ed in­ter­im CEO Leone Pat­ter­son is the best can­di­date for the job af­ter all. Pat­ter­son, who first joined Ad­verum in 2016, is now re­spon­si­ble for scal­ing its nascent clin­i­cal op­er­a­tion. The gene ther­a­py com­pa­ny will now search for a CFO in­stead to take over Pat­ter­son’s old re­spon­si­bil­i­ties.

Uli Hack­sell

→ As Medi­vir $MVIR places a re­newed fo­cus on clin­i­cal de­vel­op­ment, it’s tapped board mem­ber Uli Hack­sell as act­ing CEO, less than two years af­ter pro­mot­ing for­mer BD head Chris­tine Lind to the role. “The Board of Di­rec­tors has worked on a plan that will con­cen­trate Medi­vir’s at­ten­tion on the com­pa­ny’s ro­bust clin­i­cal pipeline com­posed of trans­for­ma­tive can­cer drugs with mul­ti-bil­lion dol­lar sales po­ten­tial,” said Hack­sell, pre­vi­ous­ly CEO of Aca­dia Phar­ma, in a state­ment.

→ Cam­bridge, UK-based al­ler­gy med de­vel­op­er Ca­mal­ler­gy has named biotech vet Bax­ter Phillips as CEO, tak­ing over from co-founder Sher­den Tim­mins, who now moves to a new COO role. Phillips brings fresh ex­pe­ri­ence from the helm of Neu­ro­gas­trx, as well as a deal­mak­ing record at Am­pliPhi Bio­sciences and De­pomed.

Tetra Bio-Phar­ma has for­mal­ly in­stalled its CSO Guy Cham­ber­land as per­ma­nent CEO, build­ing on “tremen­dous mo­men­tum” he’s es­tab­lished for the cannabi­noid-based drug com­pa­ny. While serv­ing at the helm on an in­ter­im ba­sis, Cham­ber­land was cred­it­ed with boost­ing the com­pa­ny’s share price and de­vis­ing a reg­u­la­to­ry strat­e­gy in both Cana­da and the US.

Jonathan Gold­man has land­ed his next CEO job at Abzena, con­tin­u­ing his work in the bi­o­log­ics out­sourced ser­vices field af­ter his last com­pa­ny, Ap­tu­it, was bought out by Evotec. Suc­ceed­ing John Burt, Gold­man is tasked with “es­tab­lish­ing new part­ner­ships with clients, build­ing in­ter­nal man­u­fac­tur­ing ca­pac­i­ty and pur­su­ing strate­gic ac­qui­si­tions.”

→ De­spite gar­ner­ing the avid at­ten­tion of a line­up of both big and re­mark­able de­vel­op­ment part­ners, F-star nev­er raised much cash for its op­er­a­tions from in­vestors. But that might change with the ap­point­ment of Eliot Forster, the high-pro­file biotech ex­ec who re­cent­ly left the helm at Im­muno­core, as he steps up to the CEO’s job. He’s tak­ing the top spot at a time the biotech is march­ing to­ward its first clin­i­cal de­vel­op­ment work on an in-house pipeline — putting the com­pa­ny at the cross­roads.

→ Trav­el­ing down what now seems like an in­creas­ing­ly pop­u­lar path, Mer­ck $MRK has re­cruit­ed a Nike ex­ec to be its chief in­for­ma­tion and dig­i­tal of­fi­cer. As a mem­ber of the ex­ec com­mit­tee, Jim Sc­hole­field will call the shots over Mer­ck’s in­for­ma­tion tech­nol­o­gy and dig­i­tal strat­e­gy.

→ Fresh off the heels of an R&D re­or­ga­ni­za­tion an­nounced last month, Dan­ish drug­mak­er No­vo Nordisk has ap­point­ed As­traZeneca’s Lu­dovic Helf­gott as ex­ec­u­tive vice pres­i­dent of its fledg­ling bio­phar­ma busi­ness. Helf­gott is set to re­place com­pa­ny vet­er­an and for­mer No­vo CFO Jes­per Brandgaard in April next year, who is re­tir­ing fol­low­ing a twen­ty-year stint with the Dan­ish com­pa­ny best known for its raft of di­a­betes treat­ments.

Kit­ty Yale

Kit­ty Yale is tak­ing her clin­i­cal R&D ex­per­tise to up­start biotech Akero Ther­a­peu­tics, new­ly re­lo­cat­ed to San Fran­cis­co af­ter fel­low Gilead vet An­drew Cheng was ap­point­ed CEO last month. As chief de­vel­op­ment of­fi­cer, she will steer Akero’s lead pro­gram for NASH in­to a Phase II planned for next year.

→ In an­tic­i­pa­tion of sev­er­al reg­u­la­to­ry fil­ings, Spec­trum Phar­ma­ceu­ti­cals $SP­PI has scooped Fran­cois Lebel from Zio­pharm On­col­o­gy to be its CMO. Lebel, a sea­soned on­col­o­gy drug de­vel­op­ment ex­ec with stints at Bax­ter and Med­Im­mune, will have ex­ten­sive re­spon­si­bil­i­ties cov­er­ing both clin­i­cal af­fairs and busi­ness de­vel­op­ment ac­tiv­i­ties.

David King has re­signed as CSO of aTyr Phar­ma $LIFE to start his own biotech “in a non-com­pet­i­tive area and in bi­ol­o­gy dis­tinct from” the im­muno­log­i­cal path­ways aTyr is pur­su­ing, the com­pa­ny em­pha­sizes. He will help with the tran­si­tion and re­cruit­ment of a new leader un­til the end of the year.  

Mus­tang Bio $MBIO has wooed Mar­ti­na Ser­sch, for­mer­ly of Am­gen, Genen­tech and Pfiz­er, to be its CMO. In the role, she will over­see pro­grams in im­muno-on­col­o­gy— a field she’s in­ti­mate­ly fa­mil­iar with — as well as a rare dis­ease gene ther­a­py.

→ Look­ing to bake com­mer­cial and re­im­burse­ment plans in­to its late-stage clin­i­cal work, Tyme has re­cruit­ed ex-Cel­gene sales ex­ec Michele Ko­rfin as chief com­mer­cial of­fi­cer. Ko­rfin joins the can­cer biotech from Kite Phar­ma, where she helped map the mar­ket ac­cess strat­e­gy, in­clud­ing pay­er re­la­tions and re­im­burse­ment, for the pi­o­neer­ing CAR-T ther­a­py Yescar­ta.

Abeona Ther­a­peu­tics $ABEO is bring­ing in João Sif­fert as head of R&D and chief med­ical of­fi­cer, free­ing Juan Ruiz up to be­come the head of Eu­ro­pean med­ical af­fairs. Jump­ing from a sim­i­lar role at Nes­tle Health Sci­ence, Sif­fert will be wel­comed along­side new gen­er­al coun­sel Neena Patil.

→ Af­ter a 10-year tenure at Janssen — pre­ced­ed by stints at Bio­gen and Glax­o­SmithK­lineAdam Hack­er is join­ing the small team at Au­to­lus. As SVP for reg­u­la­to­ry af­fairs and qual­i­ty, he is charged with dri­ving more of the biotech’s T cell ther­a­pies through the clin­ic.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Novavax site in Gaithersburg, MD. Novavax

Beef­ing up its new gene ther­a­py unit, Catal­ent inks $18M deal to snap up No­vavax fa­cil­i­ties

Catal­ent’s hunt for rapid growth on the gene ther­a­py front — ce­ment­ed with a $1.2 bil­lion ac­qui­si­tion of Paragon Bio­sciences two months ago — has led them to the vac­cine mak­ers at No­vavax.

With an $18 mil­lion pay­ment, Paragon is tak­ing over two No­vavax sites in Gaithers­burg, MD, in­clud­ing more than 100 of the em­ploy­ees al­ready work­ing there. That’s in ad­di­tion to a sig­nif­i­cant re­duc­tion in op­er­at­ing costs, says the com­pa­ny, as No­vavax shifts to re­ly on Paragon for GMP ma­te­ri­als in clin­i­cal tri­als and, even­tu­al­ly, com­mer­cial sup­ply of their prod­ucts.

Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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