Ver­tex COO Ian Smith oust­ed due to 'per­son­al be­hav­ior'; CFO Mats Blom ex­its Zealand Phar­ma; Ka­trine Bosley abrupt­ly ends Ed­i­tas reign

Ver­tex has oust­ed com­pa­ny COO and in­ter­im CFO Ian Smiththeir $6 mil­lion man — for per­son­al con­duct un­be­com­ing an ex­ec­u­tive at the com­pa­ny. The cys­tic fi­bro­sis drug de­vel­op­er says Smith’s ter­mi­na­tion “is the re­sult of per­son­al be­hav­ior that vi­o­lat­ed Ver­tex’s Code of Con­duct and val­ues and is un­re­lat­ed to the Com­pa­ny’s fi­nan­cial and busi­ness per­for­mance.” Chief ac­count­ing of­fi­cer Paul Sil­va will now step in as in­ter­im CFO while Ver­tex looks for a re­place­ment.

→ The cross pol­li­na­tion of ex­ec­u­tives be­tween Roche and its big biotech sub­sidiary Genen­tech is con­tin­u­ing to­day with news that the South San Fran­cis­co branch of the fam­i­ly is reel­ing back one of its for­mer ex­ecs in Basel to take the top job. Alexan­der Hardy, who start­ed at Genen­tech way back in 2005, will be tak­ing the helm March 1. He’s cur­rent­ly the head of glob­al prod­uct strat­e­gy at the big HQ base in Switzer­land, a job he land­ed af­ter a 2-year stint as head of Asia Pa­cif­ic. Hardy is tak­ing the place of Bill An­der­son, who moved to Switzer­land to be­come CEO of Roche Phar­ma­ceu­ti­cals Jan­u­ary 1 as Daniel O’Day made his move to Gilead.

Ka­trine Bosley

→ For close to 5 years now Ka­trine Bosley has led Ed­i­tas Med­i­cine $ED­IT through good times and bad, right to the thresh­old of dos­ing its first pa­tient in the pre­mier clin­i­cal study for its ground­break­ing gene-edit­ing tech. But the high-pro­file biotech CEO is un­ex­pect­ed­ly re­sign­ing from the com­pa­ny and abrupt­ly sev­er­ing her ties with the board as well. Ed­i­tas board mem­ber Cyn­thia Collins — the for­mer CEO at Hu­man Longevi­ty — is step­ping up to hold the post on an in­ter­im ba­sis, while the biotech looks for a re­place­ment.

→ Al­most two months af­ter Zealand Phar­ma an­nounced Britt Meel­by Jensen’s de­par­ture from the helm, the Copen­hagen-based com­pa­ny is see­ing off its CFO as well. Mats Blom’s re­main­ing tenure will over­lap briefly with that of new­ly ap­point­ed in­ter­im CEO Adam Steens­berg, who’s been serv­ing as EVP and chief med­ical and de­vel­op­ment of­fi­cer.

→ Days af­ter bag­ging a $100 mil­lion Se­ries B, Or­biMed-backed Apol­lomics has brought in two ex­ecs to prep for a year to be marked by a move from Hangzhou, Chi­na to Fos­ter City, CA and con­tin­ued ac­tiv­i­ties in its im­muno-on­col­o­gy pipeline. Wil­son Che­ung, for­mer­ly of KBP Bio­Sciences, is join­ing as CFO while biotech vet­er­an De­bra Thoma Vall­ner was named SVP, de­vel­op­ment op­er­a­tions. Most re­cent­ly at eF­FEC­TOR Ther­a­peu­tics, Vall­ner will now play a role in de­vel­op­ment strat­e­gy, pro­to­col de­sign, and the clin­i­cal tri­al port­fo­lio.

Anup Mar­da

Anup Mar­da has left a 17-year ca­reer at Bris­tol-My­ers Squibb to be­come CFO of Ca­balet­ta Bio, a Penn spin­out look­ing to jump­start hu­man stud­ies of a new-mod­el CAAR T cell ther­a­py aimed at au­toim­mune dis­eases

→ New York-based Neu­ro­gene has con­vinced Uni­ver­si­ty of Ed­in­burgh re­searcher Stu­art Cobb to spend half of his time lead­ing re­search for its nascent gene ther­a­py pipeline. He will help deep­en “ex­ist­ing aca­d­e­m­ic col­lab­o­ra­tions, es­tab­lish ad­di­tion­al part­ner­ships and pro­vide strate­gic guid­ance on nov­el tech­nolo­gies,” said CEO Rachel McMinn.

→ Hav­ing served as a “trust­ed ad­vi­sor” to the ex­ec­u­tive team at Flex­ion Ther­a­peu­tics $FLXN for the past nine years through a drug ap­proval and some buy­out buzz, Christi­na Will­w­erth has earned a spot in the C-suite. As chief strat­e­gy of­fi­cer, she will con­tin­ue some of the plan­ning and pri­or­i­ty set­ting work she took up as SVP of pro­gram man­age­ment and strat­e­gy, with ad­di­tion­al re­spon­si­bil­i­ties for port­fo­lio and hu­man re­sources.

Sanofi may have walked away from their re­search pact, but MyoKar­dia $MYOK is forg­ing ahead with com­mer­cial­iza­tion plans for its heart drug, ap­point­ing William Fairey as chief com­mer­cial of­fi­cer. An alum­ni of Acte­lion, Fairey was most re­cent­ly COO at Chemo­Cen­tryx. He will now plot the po­ten­tial launch mava­camten, which tar­gets the so-far un­tapped con­di­tion of ob­struc­tive hy­per­trophic car­diomy­opa­thy.

Jo­han Luth­man

→ With some pos­i­tive Phase II da­ta on its PTSD drug in hand, Lund­beck has re­cruit­ed Jo­han Luth­man to car­ry it — as well as the rest of the pipeline — for­ward as EVP and head of R&D. The ap­point­ment trig­gers a re­lo­ca­tion to Den­mark for Luth­man, a Swede who’s been liv­ing the in the US fol­low­ing a string of neu­rol­o­gy R&D roles at Ei­sai, Mer­ck, As­traZeneca and oth­ers.

→ As Sang­amo Ther­a­peu­tics $SG­MO braces for a “sig­nif­i­cant flow of clin­i­cal da­ta” from its gene edit­ing pro­grams, the Rich­mond, CA-based com­pa­ny has tapped Adri­an Woolf­son for the EVP of R&D po­si­tion. Woolf­son brings a back­ground in im­muno-on­col­o­gy, with a re­sume span­ning ge­net­ic can­cer vac­cine biotech Nous­com and Pfiz­er.

New boards have been es­tab­lished for Iron­wood and its biotech spin­out Cy­cle­ri­on. In­dus­try vet Julie McHugh will chair the Iron­wood board while Cy­cle­ri­on named Mar­sha Fanuc­ci — an ex-Gen­zyme/Mil­len­ni­um ex­ec — to the head of their new board.

Liz Bar­rett

Liz Bar­rett and George Golumbes­ki has joined the board of Sage Ther­a­peu­tics, lend­ing some heavy­weight sup­port for its cen­tral ner­vous sys­tem fo­cused pipeline, led by a post­par­tum de­pres­sion drug. While both Bar­rett and Golumbes­ki are work­ing in the can­cer field — Bar­rett as CEO of Uro­Gen af­ter a high-pro­file ex­it from No­var­tis and Golumbes­ki as pres­i­dent of can­cer de­tec­tion start­up Grail Cel­gene vet Golumbes­ki notes that his ca­reer start­ed in the CNS space.

→ As In­tel­lia Ther­a­peu­tics $NT­LA con­tin­ues down a path to first-in-hu­man stud­ies of its gene edit­ing tech, it will be get­ting ad­vice from Vi­da Ven­tures founder Fred Co­hen, its lat­est board di­rec­tor.

→ Hav­ing re­cent­ly closed an $85 mil­lion raise backed in part by GV, Schrödinger is ap­point­ing one of its ven­ture part­ners — and a fa­mil­iar face — to its board. Be­fore join­ing the fund for­mer­ly known as Google Ven­tures, Rosana Kapeller was found­ing CSO at Nim­bus, which ap­plied Schrödinger’s com­pu­ta­tion­al tech­nolo­gies in drug dis­cov­ery.

UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $200 million financing illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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Dai­ichi Sankyo sinks $200M in­to new gene ther­a­py tech from Ul­tragenyx

In a leap to the gene therapy space, Daiichi Sankyo has dropped $200 million to access Ultragenyx’s manufacturing technology, providing the rare disease biotech with plenty of cash and a stock boost amid a general cash crunch.

For $125 million in cash and a $75 million equity investment, Daiichi Sankyo has bought a non-exclusive license to the IP around two platforms with which it plans to develop AAV-based gene therapy products. The Japanese pharma is purchasing the stock $RARE at $60 per share, more than a third above its current price of $44.43.

Arie Belldegrun, Endpoints @ JPM20 Breakfast Panel. Photography by Jeff Rumans.

Mo­tion de­nied: Gilead still on the hook for $1.5B in dam­ages over CAR-T patent dis­pute with Bris­tol My­ers Squibb

Gilead’s bid to overturn a jury verdict that ordered it to pay Bristol Myers Squibb about $752 million for CAR-T patents owned by its subsidiary Juno Therapeutics has ended in vain.

The ruling leaves Gilead vulnerable to an even bigger $1.5 billion payment that Bristol is now demanding — adding fuel to the fiery criticism some analysts are already heaping on its $11.9 billion Kite buyout.

In a 30-page document unsealed on Monday, Judge James Otero of the district court in Los Angeles struck down several different arguments for a new decision. Here are Morgan Stanley analysts’ takeaways:
The court, in particular, denied Kite’s contentions (1) that Juno’s patent is invalid, (2) the damages award was unreasonable, and (3) that a new trial should take place. The court also denied Kite’s argument that its infringement was not willful.
Gilead is likely to appeal to the federal circuit, they noted, but the odds are not in their favor as the same standard for evidence will be applied in that court. Appeals typically take 16 months.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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