Seek­ing greater gen­der di­ver­si­ty, Al­ny­lam pro­motes four fe­male lead­ers; Paul Hast­ings starts post-On­coMed ca­reer as CEO of stealthy Nkar­ta

Leila Jali­nous

→ Con­sis­tent with a goal to fos­ter gen­der di­ver­si­ty in its lead­er­ship ranks, Al­ny­lam has pro­mot­ed four fe­male lead­ers to VP lev­el. Kel­ly Bier­ly is now VP, com­mer­cial coun­sel, pro­vid­ing le­gal sup­port — as she’s done at Ver­tex and Aveo On­col­o­gy — across busi­ness, med­ical and pa­tient af­fairs. Bio­gen and Sanofi vet Leila Jali­nous has as­sumed the role of VP, pro­gram & al­liance man­age­ment with cor­re­spond­ing ex­pan­sion of du­ties from in port­fo­lio strat­e­gy. Ex-Pfiz­er staffer Dawn Jarvis takes the VP po­si­tion in hu­man re­sources, while Mar­i­anne Sweetser, pre­vi­ous­ly of Bio­gen, moves up from di­rec­tor of clin­i­cal drug safe­ty to se­nior dis­tin­guished in­ves­ti­ga­tor.

Paul Hast­ings

→ Re­mem­ber when Paul Hast­ings re­signed as On­coMed’s CEO and said he was mov­ing to new pro­fes­sion­al op­por­tu­ni­ties? We now know, thanks to re­port­ing by the San Fran­cis­co Busi­ness Times, that he has land­ed the top role at a stealthy South San Fran­cis­co start­up called Nkar­ta. A joint ven­ture found­ed in 2015 by SR One, New En­ter­prise As­so­ci­ates and No­vo Ven­tures, Nkar­ta deals with can­cer, a fa­mil­iar ter­rain for Hast­ings. What dis­tin­guish­es them is a tech­nol­o­gy de­vel­oped by founder Dario Cam­pana of St Jude Chil­dren’s Re­search Hos­pi­tal, which uti­lizes NK cells in a next-gen al­lo­gene­ic cel­lu­lar im­munother­a­py plat­form.

→ Af­ter an 11-year run as CEO, Dar­rin Dis­ley has stepped down from UK gene edit­ing and mod­u­la­tion firm Hori­zon Dis­cov­ery Group. Board chair­man Ian Gilham and CFO/deputy CEO Richard Vel­la­cott will team up at the helm in the in­ter­im, as­sum­ing the roles of ex­ec­u­tive chair­man and CEO re­spec­tive­ly. Dis­ley, a re­spect­ed and in­flu­en­tial biotech ex­ec in the Cam­bridge, UK life sci­ence scene, steered the com­pa­ny through an IPO and sev­er­al ac­qui­si­tions. He’s now pur­su­ing oth­er busi­ness in­ter­ests while his for­mer col­leagues hunt for a new chief.

Sig­ur­dur (Sig­gi) Olaf­s­son

→ Hop­ing to turn its fi­nan­cial per­for­mance around, gener­ic mak­er Hik­ma has re­cruit­ed ex-Te­va ex­ec Sig­ur­dur Olaf­s­son to lead as CEO. Said Dar­wazah, the board chair­man who used to have the job, will man­age his work as ex­ec­u­tive chair­man. An Ac­tavis vet, Olaf­s­son had a taste of phar­ma at Pfiz­er R&D but spent most of his ca­reer in the gener­ic busi­ness, cul­mi­nat­ing in the pres­i­dent and CEO role of Te­va’s glob­al gener­ic med­i­cines group. He is tasked with dri­ving Hik­ma’s cor­po­rate strat­e­gy and grow­ing its glob­al busi­ness — ini­tial­ly from the US but even­tu­al­ly at Hik­ma’s head of­fice in Lon­don.

Michael Hay­den, the Te­va R&D chief who head­ed out dur­ing a mas­sive re­struc­tur­ing in De­cem­ber, has joined Vic­to­ria, British Co­lum­bia-based Au­rinia Phar­ma’s $AUPH board of di­rec­tors. Hay­den said he’s par­tic­u­lar­ly ex­cit­ed about Au­rinia’s lead pro­gram for lu­pus nephri­tis, a dis­ease that he’s at­tempt­ed to tack­le at As­pre­va, which was one of three biotechs he co-found­ed.

→ Cell ther­a­py up­start Ru­bius Ther­a­peu­tics has con­vinced Spencer Fisk to jump ship from No­var­tis to head man­u­fac­tur­ing for the Cam­bridge, MA-based biotech. Launched by Flag­ship Ven­ture­Labs, the com­pa­ny is pi­o­neer­ing a new tech called red cell ther­a­peu­tics, the first wave of which will soon en­ter clin­i­cal de­vel­op­ment. Pri­or to No­var­tis, where he helped de­vel­op and reg­is­ter the phar­ma gi­ant’s first CAR-T Kym­ri­ah, Fisk built up ex­pe­ri­ence with man­u­fac­tur­ing and process de­vel­op­ment at Mer­ck and Scher­ing Plough. CEO David Ep­stein, for­mer­ly the phar­ma chief at No­var­tis, said the ex­ecs “have been thrilled with the lev­el of tal­ent we’ve been able to at­tract to the man­age­ment team.”

Kris­tine Ball

Men­lo Ther­a­peu­tics CFO Kris­tine Ball has de­cid­ed to lend her ex­per­tise to fel­low Cal­i­for­nia up­start Forty Sev­en by join­ing the board of di­rec­tors and chair­ing of the au­dit com­mit­tee. A vet­er­an biotech ex­ec with mul­ti-mil­lion fi­nanc­ing rounds un­der her belt, Ball got her start at Ernst & Young’s life sci­ence au­dit prac­tice.

→ As Iterum Ther­a­peu­tics ac­cel­er­ates the de­vel­op­ment of its lead an­ti-in­fec­tive su­lopen­em, it has brought on Shire vet Jeff Schaffnit as its first chief com­mer­cial of­fi­cer. Hav­ing led com­mer­cial strat­e­gy for Ab­bott’s oral an­tibi­otics Bi­ax­in and Om­nicef, Schaffnit was most re­cent­ly a head of pa­tient en­gage­ment at Shire, lead­ing pa­tient ser­vices and ad­vo­ca­cy across the en­tire rare dis­ease port­fo­lio. He will now lever­age those skills to mar­ket both oral and IV for­mu­la­tions of su­lopen­em.

→ At­tract­ed to new tech in bone cell ther­a­py, Jean Stéphenne is join­ing Bel­gium’s Bone Ther­a­peu­tics as chair­man of the board, re­plac­ing Steve Swin­son. Stéphenne has kept his hands full with board ap­point­ments since re­tir­ing from the top job at GSK Vac­cines, where he worked on R&D at es­sen­tial­ly every lev­el over his 40-year tenure. The most high-pro­file biotech he’s re­cent­ly chaired is TiGenix, a stem cell ther­a­py de­vel­op­er al­so from Stéphenne’s na­tive Bel­gium, which was the sub­ject of a $630 mil­lion ac­qui­si­tion by Take­da, kick­ing off a busy M&A sea­son pre-JPM.

Sue Dil­lon has left her po­si­tion as glob­al ther­a­peu­tic area head for im­munol­o­gy in the Janssen Phar­ma­ceu­ti­cals unit of J&J to launch a new biotech called Aro Bio­ther­a­peu­tics. Her co-founder and CSO is Karyn O’Neil, the for­mer ven­ture leader for Cen­tyrex, an­oth­er J&J unit.

→ In an­oth­er case of phar­ma mi­gra­tion to biotech, Marc Schwabish has giv­en up Bay­er’s US phar­ma busi­ness de­vel­op­ment unit for the chance to run busi­ness de­vel­op­ment and US op­er­a­tions at Fu­sion Phar­ma­ceu­ti­cals. He will have broad au­thor­i­ty over li­cens­ing, part­ner­ing, com­mer­cial­iza­tion, and fi­nanc­ing ac­tiv­i­ties in­volv­ing the Cana­di­an biotech’s al­pha-par­ti­cle ra­dio­ther­a­peu­tics for can­cer. While Fu­sion is tak­ing its lead pro­gram, FPX-01 in­to the clin­ic this year, Schwabish — a for­mer banker who did a num­ber of deals for Ei­sai — will like­ly be busy scout­ing tar­get­ing mol­e­cules for in-li­cens­ing, seek­ing in­ter­est in Fu­sion’s tech plat­form and form­ing new part­ner­ships.

Pfiz­er vet John Davis has joined the mi­gra­tion out of Big Phar­ma and in­to biotech. He’s tak­en a new job as CMO at Ma­gen­ta.

Ronald Winowiec­ki has been for­mal­ly named the CFO of Per­ri­go, where he will con­tin­ue to sup­port new CEO Uwe Röhrhoff like he has since be­com­ing act­ing CFO ex­act­ly a year ago. Winowiec­ki joined the over-the-counter and gener­ic drug com­pa­ny in 2008 and has held sev­er­al fi­nan­cial man­age­ment roles since.

→ Finnish biotech Bio­hit is search­ing for a new CFO as Niklas Nord­ström joins an­oth­er com­pa­ny.

→ With sev­er­al ni­tric ox­ide pro­grams slat­ed to read out this year and a few oth­ers await­ing fi­nanc­ing, AIT Ther­a­peu­tics has ap­point­ed two new mem­bers to its ex­ec­u­tive team. Join­ing from the res­pi­ra­to­ry ther­a­py de­part­ment at Stollery Chil­dren’s Hos­pi­tal, Mark Rimkus is the new VP of clin­i­cal af­fairs re­spon­si­ble for tri­al man­age­ment, qual­i­ty sys­tems de­vel­op­ment and de­vice de­sign/test­ing. Queen’s Uni­ver­si­ty pro­fes­sor Ab­di Ghaf­fari will work fur­ther up­stream as the VP of re­search, pro­vid­ing the com­pa­ny with pre­clin­i­cal ex­per­tise to fur­ther de­vel­op the plat­form. The biotech strives to of­fer in­haled treat­ments for se­ri­ous lung in­fec­tions and pul­monary hy­per­ten­sion in both hos­pi­tal and com­mer­cial set­tings.

Oron Ya­co­by Zee­vi is the new CSO at OWC Phar­ma­ceu­ti­cal Re­search Corp over­see­ing its pipeline of cannabi­noid-based ther­a­pies. She comes to OWC from Neu­ro­derm, where she served as VP of re­search, R&D and even­tu­al­ly CSO un­til the biotech was sold to Mit­subishi Tan­abe Phar­ma for $1.1 bil­lion. Her pre­de­ces­sor, Yehu­da Baruch, will tran­si­tion to the role of chief med­ical and reg­u­la­to­ry of­fi­cer.

Cannabics Phar­ma­ceu­ti­cals $CN­BX, a US biotech with an R&D base in Tel Aviv, has hired Yasha Borstein to spear­head the de­sign and im­ple­men­ta­tion of a da­ta gov­er­nance pol­i­cy. As chief da­ta of­fi­cer, Borstein will sup­port the bioin­for­mat­ic tools that play an im­por­tant role in Cannabics’ cannabis-based per­son­al­ized an­ti-can­cer di­ag­nos­tics and pal­lia­tive treat­ments.

→ Toron­to’s Eas­t­on Phar­ma­ceu­ti­cals has ap­point­ed Daniel Ba­gi as a di­rec­tor and pres­i­dent of busi­ness de­vel­op­ment. A suc­ces­sor to Car­la Pepe, Ba­gi had pre­vi­ous­ly ne­go­ti­at­ed sub-li­cens­ing deals for Eas­t­on.

→ Laser fo­cused on be­gin­ning PhI­II en­roll­ment for its lac­tose in­tol­er­ance drug, Rit­ter Phar­ma­ceu­ti­cals has added famed gas­troen­terol­o­gist William Chey to its med­ical ad­vi­so­ry board.

→ Three long­time di­rec­tors are re­tir­ing from the board of Are­na Phar­ma $AR­NA: law pro­fes­sor Scott Bice, ex-IDEC CFO Phillip Schnei­der and Bio­gen vet Chris­tine White have all in­di­cat­ed plans to leave around June.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.