Bio­gen ex­ec Paul McKen­zie heads to CSL as COO; Pul­ma­trix CEO re­signs

Paul McKen­zie

→ Af­ter Bio­gen’s re­cent cat­a­stro­phe with ad­u­canum­ab, Paul McKen­zie, the com­pa­ny’s EVP for phar­ma­ceu­ti­cal op­er­a­tions and tech­nol­o­gy (and mem­ber of its ex­ec­u­tive com­mit­tee), jumped ship. He’s now head­ing to the Aus­tralia-based gi­ant CSL as its COO. His new job en­tails man­ag­ing CSL’s glob­al sup­ply chain. McKen­zie’s last day is May 29.

David Schi­lan­sky

→ French bio­phar­ma­ceu­ti­cal firm DBV Tech­nolo­gies an­nounced on Tues­day the de­par­ture of its deputy CEO and prin­ci­pal fi­nan­cial of­fi­cer, David Schi­lan­sky. Schi­lan­sky will re­main with the com­pa­ny through Au­gust 2019. While a search is un­der­way for a new CFO the role of deputy CEO will not be filled af­ter Schi­lan­sky’s de­par­ture. Shi­lan­sky has been with the al­ler­gy spe­cial­ist since 2011, at one point serv­ing as COO.

Robert Clarke

Pul­ma­trix CEO Robert Clarke stepped down from his po­si­tion on Thurs­day and will be im­me­di­ate­ly suc­ceed­ed by cur­rent CBO Ted Raad. Clarke will stay with the dry pow­der in­haler de­vel­op­er as an ad­vi­sor un­til Au­gust 14, 2019. Clarke was ap­point­ed CEO in 2012.

Ted Raad

Clarke said, “Af­ter fif­teen years at Pul­ma­trix grow­ing with the or­ga­ni­za­tion from Head of R&D to CSO and ul­ti­mate­ly to CEO, I’ve had the op­por­tu­ni­ty to see every as­pect of the com­pa­ny’s busi­ness. With the Pul­ma­zole pro­gram part­nered with Cipla Tech­nolo­gies, and a strong bal­ance sheet for fu­ture de­vel­op­ment, I be­lieve that the busi­ness is now head­ing in­to a promis­ing phase of its evo­lu­tion un­der Ted’s ca­pa­ble lead­er­ship.”

Michael Ca­vanaugh

→  Michael Ca­vanaugh will step up as in­ter­im CEO for Vi­tal­i­ty Bio­phar­ma and cur­rent con­troller and coun­sel of the com­pa­ny, Richard McKil­li­gan, will be pro­mot­ed to CFO and coun­sel. Ca­vanaugh will step in to re­place CEO and di­rec­tor Robert Brooke, who co-found­ed the com­pa­ny to pur­sue cannabi­noid pro­drugs.

Mi­ka Derynck

Amu­nix is fur­ther ex­pand­ing its ex­ec­u­tive team with the ap­point­ment of Mi­ka Derynck as CMO, Dar­cy Mootz as CBO and Yvonne Li as SVP of fi­nance. Ear­li­er this year, Amu­nix ap­point­ed Ang­ie You as CEO and brought on Fra­zier Life Sci­ences as a ma­jor­i­ty share­hold­er to fund and di­rect dis­cov­ery of nov­el pro­tein ther­a­peu­tics on its tech plat­form.

Ang­ie You

The new hires “bring a wealth of skills and ex­pe­ri­ences that will help ac­cel­er­ate the growth of the com­pa­ny,” said You “Their re­cruit­ment speaks to the promise of our Pro-XTEN plat­form in ad­dress­ing the key chal­lenge of on-tar­get, off-tu­mor tox­i­c­i­ty with T-cell en­gagers and cy­tokines.”

Wende Chen

Ever­est Med­i­cines wel­comed Wende Chen as chief com­mer­cial of­fi­cer of the com­pa­ny. Chen will al­so serve as an op­er­at­ing part­ner for Ever­est’s found­ing in­vestor, CBC Group, for­mer­ly known as C-Bridge Cap­i­tal. He is tasked with de­vis­ing strate­gies for Ever­est’s port­fo­lio of drugs, in-li­censed from glob­al part­ners and tar­get­ed to Asian mar­kets. Pre­vi­ous­ly, Chen served as vice pres­i­dent of cor­po­rate af­fairs, mar­ket ac­cess and chan­nel man­age­ment at Roche Phar­ma Chi­na.

Wendy Winck­ler

→ Six months af­ter woo­ing Car­o­line Loew from Bris­tol-My­ers Squibb to the helm, Glympse Bio has re­cruit­ed an­oth­er Big Phar­ma vet to its quest for dis­ease-mon­i­tor­ing sen­sors. New CSO Wendy Winck­ler joins from the No­var­tis In­sti­tutes for Bio­med­ical Re­search, where she di­rect­ed next-gen di­ag­nos­tics projects. Spun out of Sangee­ta Bha­tia’s lab at MIT and backed by Arch as well as Po­laris, Glympse Bio is get­ting ready to en­ter the clin­ic with its tech, which both de­tects dis­eases (like NASH and can­cer) and mon­i­tor pa­tients’ re­sponse to drugs.

→ Leav­ing be­hind a 17-year ca­reer at DuPont, William Fee­hery is the new CEO of Cer­tara, a provider of mod­el-in­formed drug de­vel­op­ment, reg­u­la­to­ry sci­ence, re­al-world ev­i­dence and mar­ket ac­cess ser­vices. He re­places Ed­mun­do Mu­niz, who was cred­it­ed for cast­ing a glob­al vi­sion over the past five years that Fee­hery will see to fruition.

Chris­tine Bel­lon

Beam Ther­a­peu­tics made sev­er­al lead­er­ship ap­point­ments to strength­en its man­age­ment team. The gene edit­ing biotech says that Chris­tine Bel­lon has joined as se­nior vice pres­i­dent and chief le­gal of­fi­cer; Su­san O’Con­nor has joined as chief hu­man re­sources of­fi­cer; and Suzanne Flem­ing has joined as se­nior vice pres­i­dent, fi­nance. In ad­di­tion, the com­pa­ny an­nounced that Court­ney Wal­lace has been pro­mot­ed to se­nior vice pres­i­dent and head of busi­ness de­vel­op­ment and strat­e­gy.

Su­san O’Con­nor

Tetra Nat­ur­al Health, a sub­sidiary of Tetra Bio-Phar­ma, said that it had ap­point­ed sev­er­al in­di­vid­u­als to its new board of di­rec­tors. An­dre Ran­court will be­come chair­man, while Greg Dro­han, Guy Cham­ber­land and Richard Giguère al­so joined the board ef­fec­tive Wednes­day. The com­pa­ny al­so an­nounced the ap­point­ment of Chris MacLean as COO, who is al­so COO of Panag Phar­ma and will con­tin­ue to hold the po­si­tion.

→ On Tues­day, Tetra Bio-Phar­ma an­nounced the re­tire­ment of its CFO Bernard Lessard and post­ed the ap­point­ment of Sabi­no Di Pao­la as his re­place­ment, which be­came ef­fec­tive Wednes­day.

Bi­jan Ne­jad­nik is head­ing to San­Bio as CMO of the com­pa­ny, tasked with lead­ing reg­u­la­to­ry af­fairs for its re­gen­er­a­tive med­i­cines by lever­ag­ing his vast ex­pe­ri­ence ac­crued over a long ca­reer span­ning J&J, Jazz Phar­ma, Gale­na Bio­phar­ma and Eu­re­ka Ther­a­peu­tics. Damien Bates, who un­til Wednes­day served as CMO of the com­pa­ny, will con­tin­ue to be with the com­pa­ny and in­stead, hold the po­si­tion of se­nior ad­vi­sor.

Ac­cept­ing the po­si­tion of CMO, Ne­jad­nik com­ment­ed, “I have been in­volved in the de­vel­op­ment of many new phar­ma­ceu­ti­cal drugs with a view to meet­ing un­met med­ical needs that lack ef­fec­tive treat­ment. San­Bio is a pi­o­neer in drug de­vel­op­ment for pa­tients suf­fer­ing cen­tral ner­vous sys­tem dis­or­ders. I un­der­stand that the de­vel­op­ment of SB623 has al­ready come close to the stage of prod­uct launch in Japan; tak­ing ad­van­tage of my past ex­pe­ri­ences, I will do my best to bring SB623 to pa­tients world­wide as soon as pos­si­ble.”

Christo­pher Heery

Christo­pher Heery stepped up as the new CMO of Pre­ci­sion Bio­sciences. Pre­vi­ous­ly, Heery served as CMO at Bavar­i­an Nordic. Chief de­vel­op­ment of­fi­cer, David Thom­son, com­ment­ed, “Chris brings a high­ly unique and sought-af­ter skill set to Pre­ci­sion Bio­Sciences. He has been a trans­la­tion­al clin­i­cal tri­al­ist at one of the world’s pre­em­i­nent re­search in­sti­tu­tions, NCI, where his first-in-hu­man im­munother­a­py clin­i­cal tri­als in­clud­ed a Phase I study of an an­ti-PD-L1 treat­ment (avelum­ab) that is now ap­proved for use in the Unit­ed States. Chris’s most re­cent ex­pe­ri­ence as Chief Med­ical Of­fi­cer at Bavar­i­an Nordic has giv­en him a strong un­der­stand­ing of reg­u­la­to­ry re­quire­ments, clin­i­cal tri­al over­sight, and lead­er­ship that will al­low him to play a key role in help­ing Pre­ci­sion Bio­Sciences build a suc­cess­ful clin­i­cal or­ga­ni­za­tion.”

→ Hav­ing re­cent­ly wrapped up a Phase I study for its neu­ro­pro­tec­tion drug, Barcelona’s Bionure is step­ping up its clin­i­cal game with a new leader. As CMO, Lu­cia Sep­tien will help fi­nal­ize and ex­e­cute Phase II plans for BN201, a po­ten­tial treat­ment for acute op­tic neu­ri­tis and mul­ti­ple scle­ro­sis. Sep­tien jumps from DBV Tech­nolo­gies, where she held the same role fol­low­ing pre­vi­ous stints at Pfiz­er, GSK and Ipsen.

An­tho­ny Pe­traglia

Geron is con­tin­u­ing to build its de­vel­op­ment team by adding two new se­nior lead­er­ship ap­point­ments. Ying Wan was an­nounced as vice pres­i­dent, bio­met­rics, while Patrick Mur­phy was an­nounced as vice pres­i­dent, man­u­fac­tur­ing. Both po­si­tions will sup­port the com­pa­ny’s late-stage clin­i­cal de­vel­op­ment, which in­cludes the “planned open­ing of the Phase III clin­i­cal tri­al of ime­tel­stat in low­er risk myelodys­plas­tic syn­dromes for screen­ing and en­roll­ment by mid-year 2019.”

Geo­cann an­nounced the ap­point­ment of An­tho­ny Pe­traglia as CMO of the com­pa­ny as well as chair­man of the sci­en­tif­ic and med­ical ad­vi­so­ry board. Pe­traglia is a neu­ro­sur­geon at Rochester Re­gion­al Health and serves as the ex­ec­u­tive di­rec­tor of the hos­pi­tal’s con­cus­sion pro­gram. In his new role, Pe­traglia will work close­ly with the com­pa­ny’s glob­al part­ner tech­nol­o­gy ex­change, in­clud­ing Zurich, Switzer­land-based Vesi­fact AG, as well as the or­ga­ni­za­tion’s sci­en­tif­ic and med­ical ad­vi­so­ry board com­prised of physi­cians, nurs­es and prod­uct for­mu­la­tors.


Am­ber Tong con­tributed re­port­ing

Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.
The biotech started by putting together an “arsenal” of technologies aimed at making cell therapies for cancer much, much better than the rather crude first-generation drugs that hit the market from Novartis and Kite.
Their drugs have become the baseline against which all others are being measured.
“The technology set we’re developing is independent of the chassis,” Drazan tells me. “It doesn’t have to be autologous (extracted from the patient) or allogeneic (off the shelf). It doesn’t have to be a T cell, it could be a B cell.” But they are starting out on the autologous side, where they have the most knowledge and insight into manufacturing techniques.
It also doesn’t have to be close to the clinic.
Drazan expects the biotech will be working its way through preclinical operations for “a few years,” with enough money from the $85 million launch round to get into humans.
By today’s superheated fundraising standards, that’s not a huge amount of cash. Lyell, another cell therapy 2.0 startup we featured last week, raised $600 million in a year, including a big chunk of cash from GlaxoSmithKline. Drazan is interested in dealmaking as well, but he also knows he has the cash necessary to support the company for a good run — a key part of what it takes to bring together a stellar team of top players.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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UCB tries to win some re­spect in the crowd­ed pso­ri­a­sis mar­ket with a dual IL-17 ap­proach — and it won't be easy

For a pharma company with about $5 billion in revenue, a couple of respectably sized blockbuster drugs on the market and some high-profile partners like Amgen, Belgium’s UCB has kept an unusually low profile on the pipeline side of things over the years.
Until now.
Just days after striking a $2.1 billion deal to buy Ra Pharmaceuticals and its C5 rival to Soliris, UCB is posting positive top-line Phase III results for a dual IL-17 inhibitor that it’s steering into one of the most competitive commercial spaces in the industry. And despite plenty of obvious challenges as they struggle to roll out Evenity with Amgen and patent expirations loom on its franchise drugs, including Cimzia, the company just may be ready to tackle some of the biggest players on the planet.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.
We don’t know the PASI90 and IGA scores — but UCB knows that with the kind of heavyweight competition it faces with Novartis and others, marginal gains for patients won’t stack up. So we’ll be watching for the hard numbers. And there’s another head-to-head with Cosentyx that will play a big role in pushing up analysts’ projections on peak sales, which currently fall well short of blockbuster status.
UCB hasn’t exactly been in the spotlight for the last few years, but it’s in a position now that the company has to win some respect in R&D, with blockbuster projects that can keep investors’ attention at a time the industry is experiencing booming R&D development efforts around the planet.
It hasn’t been easy. There was a setback on a lupus drug partnered with Biogen. But there have been some advances, with a deal to buy Proximagen’s NDA-ready nasal spray therapy USL261, designed as a rescue therapy for acute repetitive seizures, for $150 million in cash and another $220 million in sales and regulatory milestones. There was even a report that the company was kicking the deflated tires at Acorda, though nothing came of that.
Late last year UCB also committed to spend up to £200 million on a new R&D hub in the UK.
That may not translate into a lot of excitement right now, but they’re trying. And there’s a subtle promise that more deals may be in the works.

CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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UP­DAT­ED: Alex­ion pays $930M to buy out Achillion and its promis­ing com­pan­ion drug to Soliris

After a series of stock-crunching setbacks over the years, Achillion enjoyed a turn in the sun a few weeks ago as the FDA blessed their lead drug danicopan (ACH-4471) — a complementary therapy for PNH patients taking Alexion’s Soliris — with a breakthrough drug designation after taking a look at some solid supporting Phase II data.

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