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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.

Nick Plugis, Avak Kahvejian, Cristina Rondinone, Milind Kamkolkar and Chad Nusbaum. (Cellarity)

Cel­lar­i­ty, Flag­ship's $50M bet on net­work bi­ol­o­gy, mar­ries ma­chine learn­ing and sin­gle-cell tech for drug dis­cov­ery

Cellarity started with a simple — but far from easy — idea that Avak Kahvejian and his team were floating around at Flagship Pioneering: to digitally encode a cell.

As he and his senior associate Nick Plugis dug deeper into the concept, they found that most of the models others have developed take a bottom-up approach, where they assemble the molecules inside cells and the connections between them from scratch. What if they opt for a top-down approach, aided by single-cell transcriptomics and machine learning, to gauge the behavior of the entire cellular network?

Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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