FSD Phar­ma scoops GW Phar­ma ex­ec to guide cannabi­noid de­vel­op­ment; Zealand Phar­ma is look­ing for a new CEO

→ Just a month af­ter GW Phar­ma­ceu­ti­cals launched its pi­o­neer­ing cannabis-de­rived drug in the US, its head of mar­ket­ing has jumped to lead FSD Phar­ma, a Cana­di­an biotech that wants to fol­low GW’s foot­steps. Ru­pert Haynes will set up his own CEO of­fice in the UK, where he’s been based. FSD’s pipeline will con­sist large­ly of pain, mi­graine and CNS treat­ments like Tourette syn­drome, ob­tained through a re­cent ac­qui­si­tion of Is­rael’s Ther­a­pix.

Nick Sta­ples

→ Now that Ar­tios Phar­ma has closed its $84 mil­lion de­vel­op­ment round, chief busi­ness of­fi­cer Nick Sta­ples is mov­ing on to be­come CEO at Lo­cate Bio. The Uni­ver­si­ty of Not­ting­ham spin­out emerged from stealth mode ear­li­er this year with £2 mil­lion ded­i­cat­ed to hir­ing and ap­ply­ing its drug de­liv­ery sys­tem and gene edit­ing tech in or­tho­pe­dic re­gen­er­a­tive med­i­cine. Robin Quirk, who filled the role ad in­ter­im, is now COO.

→ Fol­low­ing a cou­ple of ca­reer de­tours via Bioven­tus and Ethicon, Sam­son Tom has re­turned to Osiris Ther­a­peu­tics $OSIR. As pres­i­dent and CEO, Tom will over­see both R&D and com­mer­cial­iza­tion of Osiris’ wound care, or­tho­pe­dics, and sports meds. In­ter­im CEO Ja­son Keefer will tran­si­tion to the CCO role.

Britt Meel­by Jensen

Zealand Phar­ma is los­ing CEO Britt Meel­by Jensen to a “non-com­pet­ing com­pa­ny” out­side its na­tive Den­mark. Jensen’s four years at the helm was marked by sev­er­al fundrais­ing ef­forts to fi­nance its new fo­cus on rare dis­ease, in­clud­ing a $77 mil­lion IPO and a $205 mil­lion roy­al­ties sale to long­time part­ner Sanofi. The search is now on for her suc­ces­sor.

→ Just 6 months af­ter land­ing the top job at Abeona Ther­a­peu­tics $ABEO, CEO Carsten Thiel has been un­cer­e­mo­ni­ous­ly boot­ed from the ex­ec­u­tive suite, ac­cused of un­spec­i­fied “per­son­al mis­con­duct” in­volv­ing his in­ter­ac­tions with col­leagues at the com­pa­ny. Ac­cord­ing to Abeona, a cell and gene ther­a­py start­up, “Thiel’s ter­mi­na­tion fol­lows an in­ves­ti­ga­tion by in­de­pen­dent mem­bers of the Com­pa­ny’s Board of Di­rec­tors and ex­ter­nal coun­sel in­to al­le­ga­tions of mis­con­duct to­wards col­leagues that the Board con­clud­ed vi­o­lat­ed the Com­pa­ny’s Code of Busi­ness Con­duct and Ethics and was in­con­sis­tent with its ex­pec­ta­tions for Abeona’s CEO.” He’s be­ing re­placed on an in­ter­im ba­sis by an­oth­er new staffer: R&D chief João Sif­fert, who was brought in just a few weeks ago.

→ No­var­tis-backed Al­tim­mune has tapped Vipin Garg to suc­ceed out­go­ing pres­i­dent and CEO Bill En­right, en­trust­ing him with grow­ing the vac­cine pipeline and ex­plor­ing part­ner­ships. Be­tween the helms of Neos Ther­a­peu­tics and Tranzyme Phar­ma, Garg has run both dis­cov­ery-stage and com­mer­cial op­er­a­tions.

→ Hav­ing as­sem­bled a large­ly pre­clin­i­cal pipeline of gene ther­a­pies through a cou­ple of li­cens­ing pacts, Ax­o­vant is ex­pand­ing the crew charged with ex­e­cut­ing its high-stakes turn­around mis­sion. All five ex­ecs com­ing on board are sea­soned vets from big-name bio­phar­ma com­pa­nies, with ex­per­tise rang­ing from man­u­fac­tur­ing and tech­ni­cal op­er­a­tions to reg­u­la­to­ry af­fairs and com­mer­cial­iza­tion.

  • Greg MacMichael, SVP of tech­ni­cal op­er­a­tions, was the for­mer glob­al head of cell and gene ther­a­py tech­ni­cal de­vel­op­ment and man­u­fac­tur­ing at No­var­tis
  • Parag Meswani, SVP of com­mer­cial strat­e­gy and op­er­a­tions, joins from Spark Ther­a­peu­tics — a US pi­o­neer of the field
  • Paul Ko­rner, SVP of clin­i­cal de­vel­op­ment, held the VP of med­ical strat­e­gy and clin­i­cal de­vel­op­ment role at Sarep­ta Ther­a­peu­tics, an­oth­er emerg­ing gene ther­a­py play­er
  • Greg Stew­art, SVP of vec­tor de­liv­ery and op­ti­miza­tion, had a stint at neu­rol­o­gy-fo­cused Voy­ager Ther­a­peu­tics
  • Sean O’Bryan, VP of reg­u­la­to­ry af­fairs, jumps from the same role at Lyso­gene

Im­muno­Gen is part­ing ways with David John­ston in the af­ter­math of a ju­ry ver­dict that found the CFO li­able for se­cu­ri­ties fraud at a pre­vi­ous com­pa­ny. The SEC con­vinced the ju­ry that John­ston had played an ac­tive role in a scheme to mis­lead in­vestors of Aveo On­col­o­gy, push­ing the line that tivozanib was head­ed for the mar­ket — fail­ing to tell them of the many big is­sues that the FDA had about their tri­al de­sign and how it was de­scribed to in­vestors. Im­muno­Gen CEO Mark Enyedy will step in with the fi­nan­cial and in­vestor re­la­tions work when John­ston leaves at year-end.

Car­lo In­cer­ti

Sanofi Gen­zyme vet Car­lo In­cer­ti is mak­ing the leap to VC life as op­er­at­ing part­ner at For­bion. Cur­rent­ly SVP, CMO and head of glob­al med­ical af­fairs of the French drug­mak­er’s rare dis­ease unit, In­cer­ti will lend a hand to the com­pa­ny build­ing work to be bankrolled by For­bion’s lat­est €360 mil­lion fund and lever­age his net­work to help star­tups in the port­fo­lio.

Thomas Jung

→ Fresh off a $46 mil­lion round led by For­bion, In­fla­zome has tapped Thomas Jung to spear­head its clin­i­cal chal­lenge to prove NL­RP3 is a great an­ti-in­flam­ma­to­ry tar­get. Jung pre­vi­ous­ly spent 13 years do­ing im­muno­log­i­cal re­search at No­var­tis — one of In­fla­zome’s found­ing in­vestors — with the no­table ex­pe­ri­ence of lead­ing de­vel­op­ment for the ill-fat­ed canakinum­ab.   

→ Ahead of an FDA de­ci­sion on its key drug Jakafi’s use in graft vs. host dis­ease, In­cyte $IN­CY has lost its chief sci­en­tif­ic of­fi­cer Reid Hu­ber to promi­nent health­care ven­ture firm Third Rock, but is bring­ing in Janssen’s Dashyant Dhanak to fill the gap.

Dhanak will need to get his act to­geth­er be­fore the up­com­ing Amer­i­can So­ci­ety of Hema­tol­ogy (ASH) con­fer­ence slat­ed for this week­end, where In­cyte is mak­ing mul­ti­ple da­ta pre­sen­ta­tions, in­clud­ing up­dat­ed da­ta for Jakafi in com­bi­na­tion with its PI3K-delta in­hibitor IN­CB50465 in pa­tients with myelofi­bro­sis. This com­bi­na­tion is ex­pect­ed to play a crit­i­cal role in ex­pand­ing the Jakafi fran­chise in myelo­pro­lif­er­a­tive neo­plasms, a group of rare dis­or­ders of the bone mar­row that cause an in­crease in the num­ber of blood cells.

Dhanak joins In­cyte as CSO and ex­ec­u­tive VP from J&J’s $JNJ Janssen, where he most re­cent­ly served as glob­al head, dis­cov­ery sci­ences. Be­fore Janssen, he spent a quar­ter of a cen­tu­ry at Glax­o­SmithK­line $GSK. Mean­while, Hu­ber, who was a found­ing mem­ber of In­cyte’s sci­en­tif­ic team, is join­ing Third Rock as a part­ner af­ter 16 years with the drug­mak­er.

Philip Gutry is the new chief busi­ness of­fi­cer at Kro­nos Bio, charged with man­ag­ing al­liances, ex­pand­ing clin­i­cal op­por­tu­ni­ties and beef­ing up the can­cer pipeline. A for­mer BD ex­ec at Re­gen­eron and a prin­ci­pal at MPM Cap­i­tal, Gutry’s re­sume al­so fea­tured a stint at Gilead Sci­ences, where Kro­nos CEO Nor­bert Bischof­berg­er led R&D for 30 years.

Con­stel­la­tion Phar­ma­ceu­ti­cals has giv­en Patrick Tro­jer a pro­mo­tion to mark his 10-year an­niver­sary with the biotech. The new CSO was one of the found­ing sci­en­tists who built the team that even­tu­al­ly came up with Con­stel­la­tion’s two clin­i­cal and oth­er pre­clin­i­cal as­sets, all aimed at mod­u­lat­ing gene ex­pres­sion.

Are­na Phar­ma­ceu­ti­cals $AR­NA has hired Robert Lisic­ki away from Re­gen­eron af­ter on­ly six months as VP car­dio-meta­bol­ic and in­flam­ma­tion. Lisic­ki is tak­ing on the chief com­mer­cial of­fi­cer at a time Are­na is mak­ing a sec­ond shot at com­mer­cial suc­cess — co-head­lined by a PAH drug that Unit­ed Ther­a­peu­tics has bought in­to — af­ter a near-death ex­pe­ri­ence with its di­et pill. A new SVP of med­ical af­fairs, Paul Au­d­hya, has al­so been on board in an ef­fort to es­tab­lish a pres­ence in Boston, the San Diego com­pa­ny not­ed.

→ Cap­ping a year of pos­i­tive piv­otal da­ta roll­out — trig­ger­ing spikes in its volatile stock price Foamix $FOMX has re­cruit­ed Jazz Phar­ma ex­ec Matt Wi­ley as its chief com­mer­cial of­fi­cer. The Is­raeli der­ma­tol­ogy biotech is start­ing to plan launch­es of FMX101 for ac­ne and FMX103 for rosacea as it gears up reg­u­la­to­ry fil­ings.

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
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 costs in com­pa­ny-wide re­org

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy reveal tomorrow 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, 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.

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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.”

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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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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.