An­tipsy­chot­ic from Lund­beck, Ot­su­ka flops again in PhI­II tri­als — this time in bipo­lar pa­tients

New Lund­beck CEO Deb­o­rah Dun­sire has more bad news to con­tend with, five months in­to her ap­point­ment. The Dan­ish drug­mak­er — which is bat­tling with gener­ics eat­ing in­to sales of three key drugs and a re­cent set­back for schiz­o­phre­nia — on Thurs­day said a pair of piv­otal tri­als failed to show its block­buster an­tipsy­chot­ic drug, br­ex­pipra­zole, helped pa­tients with bipo­lar dis­or­der.

Deb­o­rah Dun­sire

The drug, dis­cov­ered by Ot­su­ka and part­nered with the Japan­ese com­pa­ny, is al­ready ap­proved for use in ma­jor de­pres­sion and schiz­o­phre­nia and is sold un­der the brand name Rex­ul­ti.

The two, 3-week tri­als test­ed the drug ver­sus a place­bo in 650 bipo­lar I pa­tients who ex­pe­ri­enced an acute man­ic episode that re­quired hos­pi­tal­iza­tion. The main goal of ei­ther tri­al was to show br­ex­pipra­zole in­duced a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment on a com­mon rat­ing scale used to as­sess ma­nia symp­toms based on a pa­tient’s sub­jec­tive re­ports and clin­i­cian ob­ser­va­tions.

Most tri­als test­ing drugs to treat psy­chi­atric dis­or­ders fall prey to an in­flat­ed place­bo ef­fect. This case was no dif­fer­ent — in both stud­ies, a high­er-than-ex­pect­ed place­bo ef­fect was de­tect­ed, the com­pa­nies said.

The duo — who did not break out the num­bers re­flect­ing the fail­ure on Thurs­day — are con­duct­ing an analy­sis of the da­ta, and will con­se­quent­ly de­ter­mine the next steps for the pro­gram.

Leerink an­a­lysts said they were sur­prised by the fail­ure, con­sid­er­ing both Abil­i­fy and Al­ler­gan’s $AGN Vray­lar — two oth­er par­tial ag­o­nists on the D2/D3 re­cep­tors — have demon­strat­ed ef­fi­ca­cy in this in­di­ca­tion, as well as var­i­ous oth­er an­tipsy­chotics cur­rent­ly be­ing used to treat bipo­lar ma­nia. “Amongst the pos­si­ble psy­chi­a­try in­di­ca­tions that could be pur­sued in this space, Bipo­lar I man­ic episodes is one of the more “low hang­ing fruit” in­di­ca­tions, as it is of­ten the ini­tial bipo­lar spec­trum ap­proval that al­lows prod­ucts to launch or ex­pand in psy­chi­a­try – all of which adds to our sur­prise here…how­ev­er, we will not make any changes to our sales es­ti­mates for Rex­ul­ti be­cause we don’t in­clude much sales for this in­di­ca­tion any­way,” they wrote.

In 2017, two late-stage stud­ies test­ing br­ex­pipra­zole for ag­i­ta­tion trig­gered by Alzheimer’s de­men­tia threw up mixed da­ta, with one study suc­cess­ful and the oth­er deemed a fail­ure. Dun­sire, who took the reins in Sep­tem­ber, was dealt a big set­back in Oc­to­ber with a Phase III fail­ure of the com­pa­ny’s schiz­o­phre­nia drug can­di­date, Lu AF35700. How­ev­er, she had some cheer in No­vem­ber when br­ex­pipra­zole yield­ed suc­cess in a mid-stage study in pa­tients with PTSD when giv­en in com­bi­na­tion with the an­ti­de­pres­sant ser­tra­line (Zoloft).

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank. 

Once again Bischofberger and his old boss, former Gilead chief John Martin, added their own money to the new $105 million raise aimed at building up their R&D engine and the team who’s doing the drug discovery work — on both coasts. Also coming back is Arie Belldegrun, the biotech builder who sold Kite to Gilead for $12 billion, and now plays the role of global wheeler dealer who’s taking a shot at cracking the off-the-shelf CAR-T challenge at Allogene.

Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.

SJ Lee [File photo]

Go­ing in­side cells, Sung Joo Lee has sketched some big goals for his small — but glob­al — team of drug hunters

For a small biotech based in South Korea with a research arm in Cambridge, MA, Orum Therapeutics has sketched out some big goals aimed at developing antibodies for intracellular targets. And now they have a new $30 million round to push the work forward, aiming at a slate of currently undruggable quests.

Orum has been working on a platform tech out of Ajou University that relies on endocytosis to smuggle antibodies and their cargo inside a cell. They’ve published work in Nature that illustrates its preclinical potential in RAS mutations, and KRAS is on their list of targets. 

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