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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma. 

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.