No­var­tis makes its case on why RTH258 can grab a block­buster piece of Re­gen­eron's AMD mar­ket

Vas­ant Narasimhan, No­var­tis’ CEO-des­ig­nate Bloomberg

Soon-to-be No­var­tis $NVS CEO Vas Narasimhan has peeled back the cov­er on more de­tailed Phase III da­ta for their block­buster Eylea ri­val RTH258 (brolu­cizum­ab), ex­plain­ing why he be­lieves the phar­ma gi­ant has a new drug for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion that has proven to be con­sid­er­ably bet­ter than Re­gen­eron’s $5 bil­lion fran­chise ther­a­py Eylea. But he has one oth­er hur­dle to clear be­fore mak­ing a slight­ly paused ar­rival at the FDA.

In a pre­view of da­ta be­ing re­leased at the Amer­i­can Acad­e­my of Oph­thal­mol­o­gy con­fer­ence in New Or­leans, the phar­ma gi­ant’s de­vel­op­ment chief once again hit on the 52% to 57% suc­cess rate for their two big Phase II­Is. That hand­i­ly cleared the 40% to 50% bar need­ed to qual­i­fy for an im­pres­sive suc­cess set by some an­a­lysts cov­er­ing the com­pa­ny.

No­var­tis is bet­ting that mov­ing pa­tients from once every 8 weeks for Re­gen­eron’s flag­ship ther­a­py to a 12-week reg­i­men will win over a big slice of the mar­ket. But they’re back­ing up the ap­peal to pa­tients with a pitch to pay­ers and physi­cians, of­fer­ing ev­i­dence of the drug’s abil­i­ty to re­duce the flu­id that builds up be­hind the reti­na as the dis­ease pro­gress­es, which dam­ages the eye and leads to blind­ness.

“Pay­ers wants to see flu­id is­sues re­solved to make sure the dis­ease is con­trolled,” not­ed Narasimhan in a con­fer­ence call with re­porters. The drug, he ex­plains, is a nov­el an­ti­body frag­ment that is built in a way that al­lows an in­jec­tion to squirt a high con­cen­tra­tion of ther­a­py in­to the eye. Bet­ter pen­e­tra­tion is a key part of its ar­gu­ment that this drug can be more ef­fec­tive at longterm care than Eylea as well as the No­var­tis/Roche drug Lu­cen­tis.

At week 16 the two RTH258 arms had 33% and 35% few­er pa­tients with dam­ag­ing reti­nal flu­id, and at 48 weeks one arm had 41% few­er pa­tients in the dan­ger zone, com­pared to the com­peti­tor. Ac­tive dis­ease was ob­served in 23.5% of brolu­cizum­ab 6 mg pa­tients ver­sus 33.5% of afliber­cept pa­tients in HAWK, and in 21.9% of brolu­cizum­ab pa­tients ver­sus 31.4% of afliber­cept pa­tients in HAR­RI­ER.

The drug, says Narasimhan, “was con­sis­tent­ly su­pe­ri­or to Eylea.” And there’s a lot at stake, with Re­gen­eron tak­ing in $953 mil­lion in US Eylea sales in Q3.

But there is one po­ten­tial hitch. No­var­tis ob­tained the drug through the ac­qui­si­tion of a small com­pa­ny, through which they in­her­it­ed one man­u­fac­tur­ing process. No­var­tis sub­se­quent­ly de­vel­oped its own process and now reg­u­la­tors want the phar­ma team to run some pa­tients through a small test to see if the new process holds up equal­ly well.

As a re­sult, Narasimhan says the com­pa­ny plans to file at the end of next year, rather than hus­tling the drug to the agency now, as most man­u­fac­tur­ers would pre­fer. That’s to­ward the end of the H2 2018 sched­ule that No­var­tis has told in­vestors, putting back any com­mer­cial show­down with Re­gen­eron un­til lat­er in 2019, af­ter Narasimhan moves in­to his new job as­sur­ing in­vestors that the com­pa­ny knows how to de­vel­op big new prod­ucts.

That will buy Re­gen­eron some more time to line up a pos­si­ble com­pet­i­tive re­sponse. They’re work­ing on nes­vacum­ab (Ang2)/Eylea Phase II stud­ies in DME and wet AMD that an­a­lysts are watch­ing close­ly. And a spokesper­son notes that Re­gen­eron is al­so push­ing ahead with its own quar­ter­ly dos­ing reg­i­men of Eylea.

Re­gen­eron is one of the most ag­gres­sive biotechs in the in­dus­try. They won’t sim­ply stand aside as No­var­tis ze­roes in on their big fran­chise.

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).

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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Astel­las buys in­to Fre­quen­cy's re­gen­er­a­tive med strat­e­gy with a $625M al­liance on hear­ing loss

The executive team at Frequency Therapeutics never oversold the results of their maiden Phase I/II study for a new drug to rectify hearing loss. It was, they said back in April, primarily about safety and tolerability, where their drug FX-322 performed as they had hoped. 

That early glimpse of efficacy everyone searches for in their first try on humans? 

(I)mprovements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients.

We don’t know exactly what that means. But whatever the details, Astellas found enough in the data to jump in with a sizable collaboration deal.

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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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