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.

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.

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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.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Roche cracks Chi­na's ADC mar­ket open as Kad­cy­la scores its first breast can­cer OK in the coun­try

Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.

The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.

Pascal Soriot, Getty

Pas­cal So­ri­ot and As­traZeneca com­mit to car­bon neu­tral­i­ty by 2025. Where's the rest of Phar­ma?

Pascal Soriot has spent more than 20 years at the top of an industry recently found to emit more carbon than the automotive industry.

He called himself a “global citizen,” and traveled often across three-plus continents. While CEO of AstraZeneca, he commissioned a flight service — media-dubbed AstraZeneca airlines — from Cambridge to the company’s other European hub in Gothenburg. He made few, if any, public statements on the environment or his companies’ impact on it.

Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Fresh tri­al da­ta for­ti­fy po­si­tion of Roche's oral ther­a­py in spinal mus­cu­lar at­ro­phy bat­tle­ground

With an FDA decision date looming, Roche on Wednesday unveiled positive pivotal data on its blockbuster-bound oral spinal muscular atrophy (SMA) drug in patients with the most severe form of the muscle-wasting disease.

The FDA is set to make its decision on the therapy, risdiplam, by May 24. It is expected to compete with Biogen’s Spinraza and Novartis’ Zolgensma.

Partnered with PTC Therapeutics, the Roche drug was tested in 41 patients aged 1-7 months with type 1 SMA, a rare genetic muscle-wasting disease. The trial, dubbed FIREFISH, measured efficacy via the proportion of infants sitting without support after 12 months of treatment, and longer.