Kerry Blanchard (Everest)

Eli Lil­ly vet Ker­ry Blan­chard takes the helm at one of Chi­na's top deal­mak­ers, steer­ing to­ward first ap­provals

As Big Phar­ma op­er­a­tions in Chi­na con­tin­ue to bleed tal­ent to lo­cal biotech star­tups, an Eli Lil­ly vet is tak­ing on his first CEO role at one of the com­pa­nies hon­ing the mod­el of in-li­cens­ing late-stage West­ern drugs and tai­lor-mak­ing de­vel­op­ment pro­grams for the Chi­nese mar­ket.

Ever­est Med­i­cines has kept a rel­a­tive­ly low pro­file, but in its two-plus years of ex­is­tence it’s earned a spot as one of the top deal­mak­ers, mak­ing a splash last April by pay­ing a record $60 mil­lion up­front for Im­munomedics’ breast can­cer drug. Ker­ry Blan­chard is now tasked with steer­ing its eight as­sets to Chi­na ap­provals, with four reg­is­tra­tion tri­als un­der­way and two more planned lat­er this year.

“I have been aware of Ever­est Med­i­cine since its in­cep­tion in 2017,” Blan­chard told End­points News. “I was at­tract­ed by their con­cept of fo­cus­ing on tru­ly in­no­v­a­tive med­i­cines that are glob­al first in class or best in class as­sets. I be­lieve the time for first in class or best in class in on­ly Chi­na is rapid­ly com­ing to an end. Ever­est’s mod­el is a mod­el for the fu­ture; for the new era of in­no­va­tion in Chi­na.”

The drug can­di­dates span on­col­o­gy, im­munol­o­gy, car­dio-re­nal dis­ease and in­fec­tious dis­ease.

Ever­est is han­dling tri­als for er­ava­cy­cline (an­tibi­ot­ic from Tetraphase) in com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tion and etrasi­mod (S1P re­cep­tor mod­u­la­tor from Are­na) in ul­cer­a­tive col­i­tis on its own, Blan­chard said.

Ian Woo

Mean­while, the com­pa­ny will al­so par­tic­i­pate in glob­al tri­als — where Chi­na typ­i­cal­ly con­tributes 15%-20% of pa­tients — in the two oth­er pro­grams: VN­RX-5133 (an­tibi­ot­ic from Ve­na­toRX) in com­pli­cat­ed uri­nary tract in­fec­tions and ra­linepag (from Are­na) in pul­monary ar­te­r­i­al hy­per­ten­sion.

Sub­mit­ting over­seas da­ta for a Chi­na ap­proval, once a for­eign idea, is now com­mon prac­tice at the re­formed Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

“If we can, we pre­fer to join glob­al reg­is­tra­tion tri­als, but in some in­stances based on tim­ing or the ge­o­graph­ic dif­fer­ence we will per­form lo­cal or re­gion­al reg­is­tra­tion tri­als,” Blan­chard said.

One NDA — though they didn’t spec­i­fy which one — is al­so in the road map for 2020.

The CBC Group — the pow­er­house pri­vate eq­ui­ty play­er for­mer­ly known as C-Bridge Cap­i­tal — put the com­pa­ny to­geth­er. Blan­chard joined CBC group a few months ago as an op­er­at­ing part­ner af­ter a brief stint at In­novent help­ing push their PD-1 sin­til­imab over the fin­ish line. And be­fore that, he spent eight years lead­ing Chi­na drug de­vel­op­ment for Lil­ly (which part­nered with In­novent on sin­til­imab) as part of a 17-year ca­reer at the phar­ma gi­ant.

Blan­chard, who takes over from CBC man­ag­ing di­rec­tor Sean Cao, said his pri­or­i­ties al­so in­clude grow­ing the team from 100 to 200.

“Com­pe­ti­tion for tal­ent is al­ways a chal­lenge, and es­pe­cial­ly so in Chi­na,” he said. “The mar­ket is very hot and tal­ent­ed peo­ple have many op­tions.”

Then there’s the chal­lenge of get­ting Ever­est ready for com­mer­cial­iza­tion, where Wende Chan — who re­cent­ly jumped from Roche to be­come Ever­est’s chief com­mer­cial of­fi­cer — will play a ma­jor role.

Amid a new fo­cus on dis­cov­er­ing tru­ly made-in-Chi­na med­i­cines, Blan­chard hint­ed that he will ex­plore strate­gic op­por­tu­ni­ties out­side the kind of late-stage re­gion­al li­cens­ing they’re most fa­mil­iar with.

“In the near fu­ture we ex­pect our BD ac­tiv­i­ties to ex­pand to in­clude more ear­li­er-stage as­sets, where we can lever­age Chi­na’s vast clin­i­cal re­sources,” Ian Woo, pres­i­dent, and CFO added. “Longer term, we plan to cre­ate sus­tain­abil­i­ty by build­ing out dis­cov­ery ca­pa­bil­i­ties.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).