Andy Boy­er joins Te­va ex­o­dus; Achao­gen shuf­fles ex­ec­u­tive line­up

Te­va’s US chief Andy Boy­er has re­signed and is leav­ing the com­pa­ny at the end of Q1 next year, ac­cord­ing to Wells Far­go’s David Mar­ris. It has been a tur­bu­lent week at the Is­raeli gener­ics busi­ness, as new CEO Kåre Schultz un­veiled a mas­sive re­or­ga­ni­za­tion plan Thurs­day, which in­volves ax­ing 14,000 work­ers, shut­ter­ing R&D and man­u­fac­tur­ing fa­cil­i­ties and rad­i­cal­ly par­ing down $3 bil­lion in costs glob­al­ly. In a sig­nal of the in­tense fall­out, on Wednes­day, for­mer chair­man and in­ter­im CEO Yitzhak Pe­ter­burg abrupt­ly re­signed with im­me­di­ate ef­fect.

→ Next March, John Mar­tin of Gilead will tran­si­tion from ex­ec­u­tive chair­man to chair­man of the board of di­rec­tors. Mar­tin is a vet­er­an of the com­pa­ny $GILD, hav­ing served as CEO for two decades be­fore John Mil­li­gan took over. The brief an­nounce­ment did not cite a rea­son for the change, but it can be seen as a move to lessen op­er­a­tional in­volve­ment with the com­pa­ny in prepa­ra­tion for re­tire­ment.

→ Not on­ly did CMO David Apelian sell off his Achillion stock ear­li­er this month, he is now plan­ning to ex­it the New Haven, CT-based com­pa­ny at the end of the year.

→ Play­ing slow and steady, Achao­gen has an­nounced an ex­ec­u­tive switch up in the ex­ec­u­tive ranks in prepa­ra­tion for the ap­proval of its first drug, pla­zomicin. Pres­i­dent and COO Blake Wise will move to the CEO role, while cur­rent CEO Ken­neth Hillan takes the pres­i­dent po­si­tion and heads up R&D. One of the few late-stage play­ers in new an­tibi­otics, the biotech $AKAO has shown enough promise to gain in­vest­ment from the Gates Foun­da­tion. “… Blake’s ex­pe­ri­ence scal­ing and lead­ing com­mer­cial or­ga­ni­za­tions is per­fect­ly suit­ed to max­i­miz­ing this stage of growth, and val­ue, of the com­pa­ny,” said board chair­man Bryan Roberts in a state­ment. “At the same time, we are ex­treme­ly for­tu­nate to have Ken­neth in a role that ful­ly lever­ages his pas­sion and suc­cess at the in­ter­sec­tion of pre­clin­i­cal re­search and clin­i­cal drug de­vel­op­ment.”

→ Af­ter two decades at Glax­o­SmithK­line de­vel­op­ment busi­ness and pur­su­ing deals, Damien McDe­vitt has joined Aca­dia Phar­ma­ceu­ti­cals $ACAD as SVP, cor­po­rate de­vel­op­ment. The San Diego-based biotech is study­ing oth­er in­di­ca­tions for its Parkin­son’s drug Nu­plazid (pi­ma­vanserin), but al­so look­ing to “ex­plore the po­ten­tial for ex­pand­ing” their cen­tral ner­vous sys­tem port­fo­lio. In the same state­ment, the com­pa­ny not­ed that Jim Nash, SVP, tech­nol­o­gy de­vel­op­ment and op­er­a­tions, will be re­tir­ing from the com­pa­ny as of Jan­u­ary 2018. Bob Mis­chler will pick up Nash’s re­spon­si­bil­i­ties in a new role.

Pa­tri­cia Zil­liox is the new CEO at French biotech Eye­ven­sys, fol­low­ing pre­de­ces­sor Raffy Kazand­jian’s low pro­file de­par­ture in No­vem­ber (ac­cord­ing to LinkedIn). An oph­thalmic ex­pert, Zil­liox has had plen­ty of time to learn about the Paris-based com­pa­ny since join­ing its board in 2016. Pre­vi­ous­ly, she was chief drug de­vel­op­ment of­fi­cer of the Clin­i­cal Re­search In­sti­tute at the Foun­da­tion Fight­ing Blind­ness in Co­lum­bia, MD. Now, she is tasked with ad­vanc­ing Eye­ven­sys’ non-vi­ral gene ther­a­pies.

Aveo On­col­o­gy $AVEO has ap­point­ed Nikhil Mehta as its se­nior VP, reg­u­la­to­ry and qual­i­ty as­sur­ance. With big names like Bax­al­ta, Mer­ck and Shire un­der his belt, Mehta has a broad man­date to over­see all as­pects of the com­pa­ny’s reg­u­la­to­ry, qual­i­ty or tech­ni­cal op­er­a­tions. His ap­point­ment marks an­oth­er step to­wards the com­pa­ny’s quest for a do-over, as its FDA-re­ject­ed drug tivozanib scored an OK in the EU back in Au­gust.

→ En­ter­ing a new phase of growth, Kalei­do Bio­sciences has named Gen­zyme vet Al­i­son Law­ton as its pres­i­dent and COO. Af­ter a 20-plus-year run at Gen­zyme, Law­ton test­ed wa­ters at small­er biotechs like Au­ra Bio­sciences and Ova­Science be­fore join­ing the Flag­ship Ven­tures-backed start­up zoom­ing in­to the mi­cro­bio­me.

→ Rapid di­ag­nos­tics de­vel­op­er At­las Ge­net­ics has brought in Marc Jones as COO and CFO, who will team up with CEO Jef­frey Lu­ber in strate­gic di­rec­tion and ex­e­cu­tion out­side of his main func­tions. Jones and Lu­ber are old part­ners, hav­ing worked to­geth­er at Good Start Ge­net­ics in the ex­act same roles. Af­ter Good Start was ac­quired by In­vi­tae, Lu­ber got the top job at At­las al­most im­me­di­ate­ly. Now that the young com­pa­ny has ad­vanced from clin­i­cal proof of con­cept to a com­mer­cial phase, he is count­ing on his friend’s wide range of CFO ex­pe­ri­ence which al­so in­cludes T2 Biosys­tems and Ivenix.

→ Hav­ing worked on the fi­nan­cial side of things, An­drew Oh is giv­ing biotech a try as the CFO at Ru­bius Ther­a­peu­tics. An in­vestor and an­a­lyst, Oh was most re­cent­ly the chief in­vest­ment of­fi­cer and chief op­er­at­ing of­fi­cer of Leerink Phar­ma­ceu­ti­cal In­vest­ments. “Ru­bius is one of the most ex­cit­ing biotech com­pa­nies I have seen in my in­vest­ing ca­reer and has the po­ten­tial to trans­form care for peo­ple suf­fer­ing from a broad range of se­ri­ous dis­eases,” said Oh in a state­ment. “I am hon­ored to be part of a team ded­i­cat­ed to pi­o­neer­ing the next gen­er­a­tion of cel­lu­lar ther­a­pies and the de­vel­op­ment of break­through ther­a­pies for pa­tients in need.”

→ Sin­ga­pore’s Tes­sa Ther­a­peu­tics has ap­point­ed Desmond Lim as CFO. Lim joins the biotech, which fo­cus­es on cel­lu­lar im­munother­a­py for sol­id tu­mors, from out­sourc­ing com­pa­ny Hep­ta­gon.

→ At Flex­ion Ther­a­peu­tics, Scott Kel­ley has been pro­mot­ed as CMO to suc­ceed Yamo Deniz. Kel­ley moves up from VP of med­ical af­fairs, a po­si­tion he took af­ter a stint at Sanofi over­see­ing glob­al da­ta. A new as­set un­der his watch will be non-opi­oid painkiller for the knee FX-201, which Flex­ion $FLXN just ac­quired from GeneQuine Bio­ther­a­peu­tics.

→ In de­vel­op­ing AML drug Id­hi­fa, Agios had en­joyed work­ing with Cel­gene vet Jack­ie Fouse so much that it has brought her on­to its board of di­rec­tors. Since leav­ing Cel­gene, Fouse had start­ed run­ning Der­ma­vant — an­oth­er “vant” by Vivek Ra­maswamy that works on med­ical der­ma­tol­ogy.

Im­mune Phar­ma­ceu­ti­cals has re­cruit­ed John Zhang from Tesaro as VP of R&D. Zhang’s fo­cus will be on non-clin­i­cal as­pects of drug de­vel­op­ment, but will al­so pro­vide sup­port for clin­i­cal, reg­u­la­to­ry and man­u­fac­tur­ing ac­tiv­i­ties.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Vedan­ta Bio­sciences taps Big Phar­ma vet Jef­frey Sil­ber as CMO; Robert Doe­bele leaves be­hind teach­ing post at Col­orado to fo­cus on CSO job at Rain Ther­a­peu­tics

→ A Big Pharma vet has joined Cambridge, MA upstart Vedanta Biosciences to help develop and expand on its microbiome-derived bacteria portfolio.

Jeffrey Silber signed on as CMO of Vedanta after 4 years at EMD Serono as their SVP, global clinical development. Silber worked his way through the ranks at Merck in the late 1990s, eventually becoming their VP and therapeutic area head, vaccine clinical research. And after 16 years at the pharma giant, Silber moved on to AbbVie to be their VP, strategic portfolio development.

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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Sean Bo­hen's break from bio­phar­ma is over. The ex-As­traZeneca CMO has re­tired his Big Phar­ma jer­sey and is now — hap­pi­ly — run­ning a lit­tle biotech

The last I had heard about Sean Bohen, he had stepped out of his high-profile job as chief medical officer at AstraZeneca at the beginning of 2019 as CEO Pascal Soriot triggered a broad-ranging R&D shakeup. And then, earlier this week, I got a chance to catch up.

It turns out that Bohen decided at the time that he would not just jump into a new job in the booming biopharma business. As an oncologist, he had worked on the big programs at AstraZeneca, and before that he was at Genentech. That was good for a ticket to just about anyplace in the big biopharma world. But he felt it was time to stop and think things through.

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