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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma. 

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.