Andy Boy­er joins Te­va ex­o­dus; Achao­gen shuf­fles ex­ec­u­tive line­up

Te­va’s US chief Andy Boy­er has re­signed and is leav­ing the com­pa­ny at the end of Q1 next year, ac­cord­ing to Wells Far­go’s David Mar­ris. It has been a tur­bu­lent week at the Is­raeli gener­ics busi­ness, as new CEO Kåre Schultz un­veiled a mas­sive re­or­ga­ni­za­tion plan Thurs­day, which in­volves ax­ing 14,000 work­ers, shut­ter­ing R&D and man­u­fac­tur­ing fa­cil­i­ties and rad­i­cal­ly par­ing down $3 bil­lion in costs glob­al­ly. In a sig­nal of the in­tense fall­out, on Wednes­day, for­mer chair­man and in­ter­im CEO Yitzhak Pe­ter­burg abrupt­ly re­signed with im­me­di­ate ef­fect.

→ Next March, John Mar­tin of Gilead will tran­si­tion from ex­ec­u­tive chair­man to chair­man of the board of di­rec­tors. Mar­tin is a vet­er­an of the com­pa­ny $GILD, hav­ing served as CEO for two decades be­fore John Mil­li­gan took over. The brief an­nounce­ment did not cite a rea­son for the change, but it can be seen as a move to lessen op­er­a­tional in­volve­ment with the com­pa­ny in prepa­ra­tion for re­tire­ment.

→ Not on­ly did CMO David Apelian sell off his Achillion stock ear­li­er this month, he is now plan­ning to ex­it the New Haven, CT-based com­pa­ny at the end of the year.

→ Play­ing slow and steady, Achao­gen has an­nounced an ex­ec­u­tive switch up in the ex­ec­u­tive ranks in prepa­ra­tion for the ap­proval of its first drug, pla­zomicin. Pres­i­dent and COO Blake Wise will move to the CEO role, while cur­rent CEO Ken­neth Hillan takes the pres­i­dent po­si­tion and heads up R&D. One of the few late-stage play­ers in new an­tibi­otics, the biotech $AKAO has shown enough promise to gain in­vest­ment from the Gates Foun­da­tion. “… Blake’s ex­pe­ri­ence scal­ing and lead­ing com­mer­cial or­ga­ni­za­tions is per­fect­ly suit­ed to max­i­miz­ing this stage of growth, and val­ue, of the com­pa­ny,” said board chair­man Bryan Roberts in a state­ment. “At the same time, we are ex­treme­ly for­tu­nate to have Ken­neth in a role that ful­ly lever­ages his pas­sion and suc­cess at the in­ter­sec­tion of pre­clin­i­cal re­search and clin­i­cal drug de­vel­op­ment.”

→ Af­ter two decades at Glax­o­SmithK­line de­vel­op­ment busi­ness and pur­su­ing deals, Damien McDe­vitt has joined Aca­dia Phar­ma­ceu­ti­cals $ACAD as SVP, cor­po­rate de­vel­op­ment. The San Diego-based biotech is study­ing oth­er in­di­ca­tions for its Parkin­son’s drug Nu­plazid (pi­ma­vanserin), but al­so look­ing to “ex­plore the po­ten­tial for ex­pand­ing” their cen­tral ner­vous sys­tem port­fo­lio. In the same state­ment, the com­pa­ny not­ed that Jim Nash, SVP, tech­nol­o­gy de­vel­op­ment and op­er­a­tions, will be re­tir­ing from the com­pa­ny as of Jan­u­ary 2018. Bob Mis­chler will pick up Nash’s re­spon­si­bil­i­ties in a new role.

Pa­tri­cia Zil­liox is the new CEO at French biotech Eye­ven­sys, fol­low­ing pre­de­ces­sor Raffy Kazand­jian’s low pro­file de­par­ture in No­vem­ber (ac­cord­ing to LinkedIn). An oph­thalmic ex­pert, Zil­liox has had plen­ty of time to learn about the Paris-based com­pa­ny since join­ing its board in 2016. Pre­vi­ous­ly, she was chief drug de­vel­op­ment of­fi­cer of the Clin­i­cal Re­search In­sti­tute at the Foun­da­tion Fight­ing Blind­ness in Co­lum­bia, MD. Now, she is tasked with ad­vanc­ing Eye­ven­sys’ non-vi­ral gene ther­a­pies.

Aveo On­col­o­gy $AVEO has ap­point­ed Nikhil Mehta as its se­nior VP, reg­u­la­to­ry and qual­i­ty as­sur­ance. With big names like Bax­al­ta, Mer­ck and Shire un­der his belt, Mehta has a broad man­date to over­see all as­pects of the com­pa­ny’s reg­u­la­to­ry, qual­i­ty or tech­ni­cal op­er­a­tions. His ap­point­ment marks an­oth­er step to­wards the com­pa­ny’s quest for a do-over, as its FDA-re­ject­ed drug tivozanib scored an OK in the EU back in Au­gust.

→ En­ter­ing a new phase of growth, Kalei­do Bio­sciences has named Gen­zyme vet Al­i­son Law­ton as its pres­i­dent and COO. Af­ter a 20-plus-year run at Gen­zyme, Law­ton test­ed wa­ters at small­er biotechs like Au­ra Bio­sciences and Ova­Science be­fore join­ing the Flag­ship Ven­tures-backed start­up zoom­ing in­to the mi­cro­bio­me.

→ Rapid di­ag­nos­tics de­vel­op­er At­las Ge­net­ics has brought in Marc Jones as COO and CFO, who will team up with CEO Jef­frey Lu­ber in strate­gic di­rec­tion and ex­e­cu­tion out­side of his main func­tions. Jones and Lu­ber are old part­ners, hav­ing worked to­geth­er at Good Start Ge­net­ics in the ex­act same roles. Af­ter Good Start was ac­quired by In­vi­tae, Lu­ber got the top job at At­las al­most im­me­di­ate­ly. Now that the young com­pa­ny has ad­vanced from clin­i­cal proof of con­cept to a com­mer­cial phase, he is count­ing on his friend’s wide range of CFO ex­pe­ri­ence which al­so in­cludes T2 Biosys­tems and Ivenix.

→ Hav­ing worked on the fi­nan­cial side of things, An­drew Oh is giv­ing biotech a try as the CFO at Ru­bius Ther­a­peu­tics. An in­vestor and an­a­lyst, Oh was most re­cent­ly the chief in­vest­ment of­fi­cer and chief op­er­at­ing of­fi­cer of Leerink Phar­ma­ceu­ti­cal In­vest­ments. “Ru­bius is one of the most ex­cit­ing biotech com­pa­nies I have seen in my in­vest­ing ca­reer and has the po­ten­tial to trans­form care for peo­ple suf­fer­ing from a broad range of se­ri­ous dis­eases,” said Oh in a state­ment. “I am hon­ored to be part of a team ded­i­cat­ed to pi­o­neer­ing the next gen­er­a­tion of cel­lu­lar ther­a­pies and the de­vel­op­ment of break­through ther­a­pies for pa­tients in need.”

→ Sin­ga­pore’s Tes­sa Ther­a­peu­tics has ap­point­ed Desmond Lim as CFO. Lim joins the biotech, which fo­cus­es on cel­lu­lar im­munother­a­py for sol­id tu­mors, from out­sourc­ing com­pa­ny Hep­ta­gon.

→ At Flex­ion Ther­a­peu­tics, Scott Kel­ley has been pro­mot­ed as CMO to suc­ceed Yamo Deniz. Kel­ley moves up from VP of med­ical af­fairs, a po­si­tion he took af­ter a stint at Sanofi over­see­ing glob­al da­ta. A new as­set un­der his watch will be non-opi­oid painkiller for the knee FX-201, which Flex­ion $FLXN just ac­quired from GeneQuine Bio­ther­a­peu­tics.

→ In de­vel­op­ing AML drug Id­hi­fa, Agios had en­joyed work­ing with Cel­gene vet Jack­ie Fouse so much that it has brought her on­to its board of di­rec­tors. Since leav­ing Cel­gene, Fouse had start­ed run­ning Der­ma­vant — an­oth­er “vant” by Vivek Ra­maswamy that works on med­ical der­ma­tol­ogy.

Im­mune Phar­ma­ceu­ti­cals has re­cruit­ed John Zhang from Tesaro as VP of R&D. Zhang’s fo­cus will be on non-clin­i­cal as­pects of drug de­vel­op­ment, but will al­so pro­vide sup­port for clin­i­cal, reg­u­la­to­ry and man­u­fac­tur­ing ac­tiv­i­ties.

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.

Swamy Vijayan. Plexium

San Diego up­start de­buts dis­cov­ery en­gine that puts a twist to pro­tein degra­da­tion

For years, the idea of protein degradation — utilizing the cell’s natural garbage disposal system to mark problematic proteins for destruction — remained an elegant but technically difficult concept. But now established as a promising clinical strategy, with major biopharma players such as Bayer, Gilead and Vertex trying to grab a foothold via partnership deals, a San Diego startup is looking to exploit it and push its limits.

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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