Peer Re­view: Leav­ing Cere­cor af­ter a year, Pe­ter Green­leaf starts a new CEO chap­ter at Au­rinia — out to slay Resta­sis

Pe­ter Green­leaf

→ A year af­ter or­ches­trat­ing Su­cam­po Phar­ma’s sale to Mallinck­rodt, Pe­ter Green­leaf is still in hot de­mand. Au­rinia has poached him from the helm of Cere­cor, where he’s helped lay a foun­da­tion for a new pipeline for or­phan neu­ro­log­i­cal dis­or­ders in the past year.

At Au­rinia, the new CEO will shift gears to oph­thal­mol­o­gy and im­munol­o­gy as the Cana­di­an biotech launch­es an am­bi­tious chal­lenge to Al­ler­gan’s best-sell­ing dry eye drug Resta­sis. In a Phase II head-to-head read out weeks ago, Au­rinia’s vo­closporin demon­strat­ed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment on ef­fi­ca­cy com­pared to Resta­sis — a sur­pris­ing win on a sec­ondary end­point. The pri­ma­ry end­point of beat­ing the block­buster drug’s tol­er­a­bil­i­ty score was not met.

Au­rinia is keen­ly plan­ning a larg­er Phase II/III tri­al, and Green­leaf — “a thought­ful and de­ci­sive leader” ac­cord­ing to H C Wain­wright an­a­lysts — al­so led His­to­gen­ics and As­traZeneca’s big Med­Im­mune unit. As Au­rinia keen­ly plans a larg­er Phase II/III tri­al for vo­closporin, he will play a key role across clin­i­cal, busi­ness de­vel­op­ment and com­mer­cial op­er­a­tions.

The com­pa­ny’s main fo­cus is its lu­pus pro­gram, for which late-stage da­ta are ex­pect­ed by the end of 2019.

“I am very ex­cit­ed to lead the com­pa­ny at this piv­otal time and through sev­er­al crit­i­cal dat­a­points over the next year in­clud­ing Phase III tri­al re­sults by the end of 2019, fol­lowed by the planned reg­u­la­to­ry sub­mis­sion and prepa­ra­tions for the po­ten­tial com­mer­cial­iza­tion of vo­closporin dur­ing 2020,” Green­leaf said in a state­ment.

→ Hong Kong-based Uni-Bio Sci­ence has tapped a sea­soned fi­nan­cial ex­ec to steer the ship. This is Zhao Zhi Gang’s first try at be­ing a biotech CEO, hav­ing start­ed his ca­reer as an ac­coun­tant and moved up to CFO roles at Chi­na’s life sci­ences com­pa­nies, most re­cent­ly Sim­cere Phar­ma. HKEX-list­ed Uni-Bio Sci­ence made its mon­ey in man­u­fac­tur­ing but is work­ing on new drugs for di­a­betes, oph­thal­mol­o­gy and der­ma­tol­ogy.

→ A year af­ter leav­ing Astel­las to join Alk­er­mes $ALKS, Jim Robin­son is re­sign­ing from the CNS biotech. Robin­son, who will re­main pres­i­dent and COO for one more week, called it an “ex­ceed­ing­ly dif­fi­cult de­ci­sion” trig­gered by per­son­al rea­sons. His tenure co­in­cid­ed with a tough year for Alk­er­mes, which was bat­tered with re­peat­ed FDA ob­jec­tions to its de­pres­sion drug ALKS-5461.

Gary Alt­man is em­bark­ing on his next com­pa­ny-shap­ing mis­sion as CEO of IGF On­col­o­gy, which is de­vel­op­ing a con­ju­gate of methotrex­ate and a pro­pri­etary re­com­bi­nant pro­tein de­riv­a­tive of in­sulin-like growth fac­tor-1 (IGF-1) for myelodys­plas­tic syn­drome. A for­mer CEO of Pro­vista Di­ag­nos­tics and COO of Hu­man Longevi­ty, Alt­man’s longest run­ning role is prin­ci­pal of his own con­sult­ing firm with as­sign­ments in­clud­ing turn­arounds, star­tups and M&A, ac­cord­ing to his LinkedIn pro­file.

An­drew Southan’s quick as­cent at CRO Metri­on Bio­sciences has cul­mi­nat­ed in a pro­mo­tion to CEO. Hav­ing joined the ion chan­nel con­tract re­search and drug dis­cov­ery com­pa­ny as head of com­mer­cial op­er­a­tions in 2016, be­come COO in 2017 and joined the board of di­rec­tors in 2018, Southan — an alum of Charles Riv­er Lab­o­ra­to­ries pledges to ex­pand the UK com­pa­ny’s glob­al rep­u­ta­tion.

→ Leav­ing the stage at En­do­cyte af­ter the cur­tains are drawn fol­low­ing No­var­tis’ $2.1 bil­lion buy­out for the ra­dio­phar­ma­ceu­ti­cals com­pa­ny, Michael Sher­man has land­ed his next CEO job at Chimerix $CM­RX. And he’s bring­ing a friend with him: Michael An­dri­ole, En­do­cyte’s CFO, will be scout­ing deals for the Chimerix’s an­tivi­rals as its chief busi­ness of­fi­cer. His ap­point­ment comes af­ter Michelle Berrey — the woman who re­placed Chimerix CEO Ken­neth Moch in 2014 af­ter the com­pa­ny no­to­ri­ous­ly sparked a vi­ral protest move­ment af­ter a dy­ing child was ini­tial­ly de­nied com­pas­sion­ate use of its ex­per­i­men­tal treat­ment — stepped down for undis­closed rea­sons.

Robert Zeldin wrapped a brief CMO stint at Ac­celeron just as the biotech and its part­ner Cel­gene sub­mit­ted an NDA for billed block­buster lus­pa­ter­cept. “We spoke to man­age­ment and learned that the CMO’s de­par­ture was due to lack of cul­tur­al fit,” Cowen’s Yaron Wer­ber wrote in a note, adding that “he did not have a ma­jor role in de­sign­ing on­go­ing stud­ies.” Zeldin moved to Ac­celeron af­ter his for­mer em­ploy­er, Abl­ynx, was ac­quired by Sanofi.

Scott Plevy

Syn­log­ic has poached gas­troen­terol­o­gy ex­pert Scott Plevy from Janssen to lead its re­search en­deav­ors. As CSO, Plevy will dri­ve de­vel­op­ment of Syn­log­ics’ plat­form, which reengi­neers bac­te­ria in­to “liv­ing med­i­cines” with po­ten­tial to treat meta­bol­ic dis­eases, im­mune-me­di­at­ed dis­eases and can­cer.

→ The re­gen­er­a­tive spe­cial­ists at Sur­rozen is wel­com­ing Trudy Van­hove to their team as CMO. Most re­cent­ly at Jazz Phar­ma, she will help se­lect and move Sur­rozen bi-spe­cif­ic an­ti­bod­ies in­to clin­i­cal de­vel­op­ment — some­thing that the Bay Area biotech re­cent­ly banked $50 mil­lion to do. Sur­rozen’s key ca­pac­i­ty has to do with se­lec­tive mod­u­la­tion of the Wnt path­way, a crit­i­cal part of tis­sue re­pair that’s al­so pur­sued by the biotech uni­corn Sa­mumed.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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