Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

Ter­rie Cur­ran

→ Gas­troin­testi­nal dis­ease-fo­cused Phath­om Phar­ma­ceu­ti­cals has shak­en up its lead­er­ship team. The com­pa­ny has tapped for­mer Cel­gene ex­ec Ter­rie Cur­ran as CEO, suc­ceed­ing David Socks, who is tran­si­tion­ing to in­ter­im CFO. Cur­ran was pres­i­dent of Cel­gene’s glob­al in­flam­ma­tion and im­munol­o­gy fran­chise — help­ing with the sale of Ote­zla for $13.4 bil­lion to Am­gen — and has held a pre­vi­ous stint at Mer­ck. In ad­di­tion to Cur­ran, the com­pa­ny al­so wel­comed for­mer Omeros CMO Eck­hard Leifke as CMO, ex-Cel­gene ex­ec Joseph Hand as chief ad­min­is­tra­tive of­fi­cer, and for­mer gen­er­al coun­sel for Cy­cle­ri­on Ther­a­peu­tics Lar­ry Miller as gen­er­al coun­sel. They al­so re­placed Chris Slavin­sky on the board with Take­da ex­ec Asit Parikh.

Mar­tin Williams

Mar­tin Williams has tak­en the reins at Car­away Ther­a­peu­tics as the com­pa­ny’s new CEO. Most re­cent­ly, Williams served as the ex­ec­u­tive chair­man at Yu­ma Ther­a­peu­tics, which he co-found­ed. His pre­vi­ous stints in­clude roles as CEO of Tokai Phar­ma­ceu­ti­cals and CBO of Dicer­na Phar­ma­ceu­ti­cals and Syn­ta Phar­ma­ceu­ti­cals. Williams’ ap­point­ment comes af­ter the neu­rode­gen­er­a­tive dis­ease-fo­cused com­pa­ny named Cristi­na Csim­ma chair of the com­pa­ny’s board of di­rec­tors ear­li­er this year.

→ Af­ter a clean sweep of its C-suite a few months ago, Akcea has grabbed Alex Howarth to be the com­pa­ny’s new COO. Howarth, a for­mer GSK ex­ec (lead­ing GSK Ven­ture Part­ner­shipswill take charge of cor­po­rate strat­e­gy, busi­ness de­vel­op­ment, man­age­ment of stake­hold­er al­liances, le­gal and com­pli­ance.

→ San Fran­cis­co-based de­vel­op­er Nu­ve­lu­tion — which back in 2017 struck a pact and gam­bled big on a Phase III study to ap­ply Te­va’s Auste­do to Tourette syn­drome — has snagged Ronald Martell as the com­pa­ny’s pres­i­dent and CEO. Martell most re­cent­ly was founder and ex­ec­u­tive chair­man of In­dap­ta and CEO at Achieve Life Sci­ences. His ré­sumé al­so in­cludes roles at HAVAH Ther­a­peu­tics, Im­Clone Sys­tems, Roche and Genen­tech — where he was re­spon­si­ble for build­ing the com­pa­ny’s on­col­o­gy fran­chise, in­clud­ing the launch of Her­ceptin for metasta­t­ic HER-2 pos­i­tive breast can­cer and Rit­ux­an for non-Hodgkin’s lym­phoma. 

Ronald Martell

In­cep­tuawhich re­cent­ly inked an ex­clu­sive clin­i­cal tri­al sup­ply agree­ment with Ger­man on­col­o­gy gener­ics man­u­fac­tur­er Ben­dalishas named Paul Wi­tuschek as pres­i­dent of the com­pa­ny’s North Amer­i­can busi­ness. He will be based in the US. In this new role, Wi­tuschek will take on le­gal re­spon­si­bil­i­ty of the com­pa­ny’s US af­fil­i­ate and lead the North Amer­i­can busi­ness de­vel­op­ment of In­cep­tua’s three busi­ness units: Clin­i­cal Tri­al Ser­vices, Med­i­cines Ac­cess and In­cep­tua Phar­ma. Pre­vi­ous­ly, Wi­tuschek served as ex­ec­u­tive vice pres­i­dent of glob­al busi­ness de­vel­op­ment for ICON and served as VP, glob­al busi­ness de­vel­op­ment for Catal­ent Phar­ma So­lu­tions.

→ Af­ter abrupt­ly call­ing off their IPO in Au­gust and re­viv­ing it once more in Oc­to­ber, RAPT Ther­a­peu­tics has named Rod­ney Young as CFO. Most re­cent­ly Young served in the same role at Celler­ant Ther­a­peu­tics and pre­vi­ous­ly was CFO and VP of fi­nance and ad­min­is­tra­tion for Stem­Cells, where he was re­spon­si­ble for rais­ing over $200 mil­lion in fi­nanc­ing. Young’s ap­point­ment came a day be­fore the com­pa­ny inked a col­lab­o­ra­tion with South Ko­rea’s Han­mi Phar­ma­ceu­ti­cals worth $10 mil­lion up­front and up to $108 mil­lion in po­ten­tial de­vel­op­ment and sales mile­stones. 

Paul Wi­tuschek

Glen­mark spin­off Ich­nos Sci­ences, led by Gilead vet Alessan­dro Ri­va, has made two new ad­di­tions to the team with the ap­point­ments of Patrick Flani­gan as CFO and Mar­tin Wil­son as gen­er­al coun­sel. Pri­or to his new role, Flani­gan served as SVP of in­vestor re­la­tions & trea­sury for Cel­gene. Wil­son comes from Teligent where he served as gen­er­al coun­sel and has pre­vi­ous ex­pe­ri­ence from stints at En­do Phar­ma­ceu­ti­cals, Par Phar­ma­ceu­ti­cal and Scher­ing-Plough.

→ Phar­ma­cy ben­e­fit man­ag­er Prime Ther­a­peu­tics has se­cured Chris­tine Bent as the com­pa­ny’s COO. Bent joins the com­pa­ny af­ter a stint as SVP of op­er­a­tions at Al­li­na Hos­pi­tal and Clin­ics and for­mer roles at Min­neapo­lis Heart In­sti­tute and Atrius Health.

Af­ter back­ing in­fec­tious dis­ease start­up AN2 Ther­a­peu­tics and ink­ing a deal for their lead TB drug, Brii Bio­sciences has brought on GSK vet John Kraus as SVP, neu­ro­sciences ther­a­py area and Zhi­jianJamesChen as a strate­gic sci­en­tif­ic ad­vi­sor. Most re­cent­ly, Kraus served as VP, drug de­vel­op­ment ser­vices for ICON and pre­vi­ous­ly held a 12-year stint at GSK, fo­cus­ing on the neu­ro­sciences ther­a­py area unit and de­vel­op­ing treat­ments for a va­ri­ety of CNS dis­eases. Chen, a pro­fes­sor, is an in­ves­ti­ga­tor at Howard Med­ical In­sti­tute. Pre­vi­ous­ly, Chen was a se­nior sci­en­tist at Pro­Script, where he helped dis­cov­er the pro­tea­some in­hibitor Vel­cade — used to treat mul­ti­ple myelo­ma.

Zhi­jian “James” Chen

→ Neur­al ex­o­some de­vel­op­er for the treat­ment of neu­rode­gen­er­a­tive dis­eases Aruna Bio has ap­point­ed James Paskavitz as VP of re­search and de­vel­op­ment. Paskavitz most re­cent­ly served as se­nior med­ical di­rec­tor at Sage Ther­a­peu­tics. Pri­or to Sage, Paskavitz was med­ical di­rec­tor at Bio­gen, lead­ing the com­pa­ny’s Parkin­son’s dis­ease imag­ing and tech­nol­o­gy pro­gram along with fa­cil­i­tat­ing ear­ly de­vel­op­ment in Alzheimer’s, ALS and mul­ti­ple scle­ro­sis. In ad­di­tion, he has served as med­ical di­rec­tor at both Ver­tex Phar­ma­ceu­ti­cals and Parex­el.  

Ax­o­vant spin­out Arvelle Ther­a­peu­tics — part­ner to SK Bio­phar­ma, which re­cent­ly bagged an $850 mil­lion IPO in Ko­rea — has ap­point­ed for­mer ex­ec and COO of Acte­lion Ot­to Schwarz as chair to its board of di­rec­tors and as an in­de­pen­dent di­rec­tor. 

Alex Howarth

Bioa­sis Tech­nolo­gies — a com­pa­ny de­vel­op­ing the xB³ plat­form, tech­nol­o­gy for the de­liv­ery of ther­a­peu­tics across the blood-brain bar­ri­er (BBB) and the treat­ment of cen­tral ner­vous sys­tem (CNS) dis­or­ders — has an­nounced the cre­ation of the med­ical on­col­o­gy ad­vi­so­ry board with three ap­point­ments: John De­G­root, chair­man ad in­ter­im in the de­part­ment of neu­ro-on­col­o­gy at MD An­der­son; pro­fes­sor of med­i­cine at UCSF Hope Ru­go; and co­or­di­na­tor at the Hos­pi­tal Vall d’He­bron in Barcelona Javier Cortés. The board’s chair will be José Igle­sias, who has been ap­point­ed con­sul­tant CMO for the com­pa­ny and has held pre­vi­ous stints at Eli Lil­ly and Am­gen. The goals of this board will be to guide the clin­i­cal strat­e­gy and de­sign of the xB3-001 clin­i­cal pro­gram for the treat­ment of HER2+ breast can­cer and brain metas­tases. 

Evelo Bio­sciences, which de­vel­ops bi­o­log­ics, has wel­comed Juan An­dres to its board of di­rec­tors. An­dres is cur­rent­ly the chief tech­ni­cal op­er­a­tions and qual­i­ty of­fi­cer at Mod­er­na

The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their metal model, was 32.

The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pioneered directed evolution; Feng Zhang, 31 when he published his CRISPR paper.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

Decisions that once required months would be measured in hours under the Coronavirus Treatment Acceleration Program. “In many cases” trial protocols could be hammered out in less than a single day. If you had a potential solution to the crisis, the appropriate staffer would be in touch “to get studies underway quickly.”

It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

But it’s clear that for some — and quite likely many — biopharma execs, the actual agency response has not measured up to the promise. Beyond the front ranks of advanced companies in the field, like Gilead, or for drugs endorsed by President Trump, it may not even come close.

“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

GSK's Hal Bar­ron buys a $250M stake in George Scan­gos' Vir and makes a bee­line to the clin­ic with Covid-19 an­ti­bod­ies

GlaxoSmithKline is diving straight into the swirling waters of Covid-19 R&D work, and investing $250 million to grab a chunk of equity in one of the emerging stars in infectious disease research to make it official.

GSK put out word this morning that it is partnering with Vir Biotechnology $VIR, the infectious disease startup founded in the Bay Area by former Biogen CEO George Scangos. They’re planning a leap into Phase II studies for 2 preclinical antibody candidates — VIR-7831 and VIR-7832 — that have been engineered to target the SARS-CoV-2 spike protein.

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An­oth­er day, an­oth­er boat­load for biotech. Deer­field adds $840M to rush of ven­ture dol­lars

The biotech dollars just keep rolling in.

Even as the world economy faces an economic contraction unprecedented in nature, biotech venture capital firms are announcing huge new investment pots. The latest? Deerfield Management Co.

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Small mol­e­cules, bi­o­log­ics and now gene ther­a­pies: Ger­many's Evotec adds an­oth­er feath­er to its R&D cap

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

A pair of PhI­II fail­ures spells last rites for Men­lo’s once-promis­ing Mer­ck drug

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.

Af­ter putting aside a bit­ter le­gal feud, Al­ny­lam and Dicer­na chiefs make nice with an RNAi col­lab­o­ra­tion

John Maraganore and Douglas Fambrough used to be at each other’s throats as Alnylam pursued claims that its RNAi rivals at Dicerna had improperly purloined the IP it had picked up from Merck in a bargain basement fire sale.

But that was all settled up close to 2 years ago with a settlement from Dicerna’s Fambrough. And now the two are moving ahead in a close R&D partnership that makes them collaborators on a couple of key disease targets.

Gilead CEO Daniel O'Day attends a meeting with the President and other biopharma leaders at the White House on March 2, 2020 (AP Photo)

Ramp­ing up glob­al pro­duc­tion of remde­sivir, Gilead CEO Dan O’Day de­tails plans to dis­trib­ute 1.5M dos­es to fight Covid-19 — for free

Gilead is still some days away from turning the card on its first round of data on remdesivir’s ability to fight severe cases of Covid-19, but the big biotech is ramping up an emergency supply of a million courses of therapy as it starts free distribution of the drug to tens of thousands of patients under their compassionate use and expanded access program as well as clinical trials.

In his latest open letter posted over the weekend, Gilead CEO Dan O’Day outlined how the company has been successful in cutting production time on remdesivir while repurposing some of their own facilities and turning to contract manufacturers to build a near-term supply of 1.5 million doses. They are still working on efficacy and dosing, but that supply could cover 140,000 courses of treatment. That supply, he added, would be more widely available following a potential approval.