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

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

Ku­ra co-founder heads to Asian mul­ti-na­tion­al as biotech eyes the goal posts for lead drug

Six years after Kura Oncology snagged a farnesyl transferase inhibitor from J&J and leapt straight into clinical development, one of the biotech’s founders is leaving to start a new chapter in his career.

CMO and development chief Antonio Gualberto is exiting the company, and Kura — led by longtime biotech entrepreneur Troy Wilson — is on the hunt for a replacement. Wilson credited the CMO for some key biomarker work, including the discovery of the CXCL12 pathway as a target of their lead drug tipifarnib. Those biomarkers are being relied on to define the patient population most likely to benefit from the drug.

FDA waves Epizyme's $186K rare can­cer drug through to mar­ket — now get ready for the sec­ond act

After winning the hearts of the expert panel convened by the FDA despite a bleak in-house review and a checkered development history, Robert Bazemore has steered Epizyme to its first-ever OK for a rare cancer drug.

The approval in epithelioid sarcoma sets tazemetostat, now Tazverik, up nicely for a quick expansion to follicular lymphoma — a much bigger indication for which the biotech has just submitted an NDA.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

2019 a 'trans­for­ma­tive year' for phar­ma M&A. Is that a good thing?

Big Pharma keeps getting bigger.

Fueled by the mega-mergers between Bristol-Myers Squibb and Celgene and between Allergan and AbbVie, the industry last year saw $350 billion worth of M&A, according to the new year-end report from the consultants at PwC.  That’s a more than 50% increase on 2018.

“I kind of look at 2019 as a transformational year,” report author Glen Hunzinger told Endpoints News. 

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.