Gilead vet Alessan­dro Ri­va steers Glen­mark's biotech spin­off on in­de­pen­dent course

Alessan­dro Ri­va turned heads when he left his on­col­o­gy post at Gilead to front a new Glen­mark ven­ture. What was one of the in­dus­try’s top can­cer ex­ecs do­ing at a gener­ic drugs com­pa­ny?

Alessan­dro Ri­va

“No­body knew — or few peo­ple knew — that Glen­mark had and has 400 peo­ple ded­i­cat­ed to in­no­va­tion,” Ri­va told End­points News. 

The in­no­va­tion arm is now try­ing to make its name known as it spins off from Glen­mark and launch­es to­day as Ich­nos Sci­ences. With a base in Para­mus, New Jer­sey, a bi­o­log­ics wing in Switzer­land and a new chem­i­cal en­ti­ty re­search branch in In­dia, Ich­nos will clin­i­cal­ly de­vel­op five mol­e­cules aimed at first in class treat­ments for can­cer, au­to-im­mune dis­or­ders and pain.

Glen­mark ap­proved the spin­off in Feb­ru­ary. Ri­va said the new com­pa­ny was formed so Glen­mark could give suf­fi­cient at­ten­tion to the re­search, from busi­ness strat­e­gy to de­vel­op­ment.

“I joined in the be­gin­ning of April and this was one of my first ques­tions if not my on­ly one,” Ri­va said, adding he saw the an­swer first hand in the months lead­ing to the launch. “Glen­mark has re­al­ized that do­ing in­no­va­tion in au­to-im­mune, in on­col­o­gy and in pain is a dif­fer­ent busi­ness than do­ing gener­ic drugs and it re­quires a dif­fer­ent ap­proach.”

Glen­mark, though, may have had broad­er and less rosy rea­sons for the change. Be­fore the of­fi­cial launch, Fier­cePhar­ma saw the move as part of a se­ries of ef­forts by a debt-laden com­pa­ny to get lean­er. The In­di­an gi­ant al­so spun off its API busi­ness.

“We are di­vest­ing a num­ber of non­core as­sets,” Glen­mark chief ex­ec­u­tive Glenn Sal­dan­ha told Fier­cePhar­ma last month.

Glenn Sal­dan­ha Glen­mark

Glen­mark is the on­ly in­vestor in Ich­nos so far, al­though Ri­va said they were plan­ning to move an IPO when the da­ta lets them. He em­pha­sized they were a ful­ly in­de­pen­dent com­pa­ny.

At Gilead, Ri­va over­saw a can­cer di­vi­sion pumped with cash in the wake of the Kite buy­out, al­though one that strug­gled to es­tab­lish its CAR-T ther­a­py in the mar­ket­place.

Two of Glen­mark’s 5 com­pounds are on­co­log­i­cal. They’re CD3-tar­get­ed treat­ments for mul­ti­ple myelo­ma and re­frac­to­ry breast can­cer, both in Phase IA/B. Roche, Am­gen and J&J, among oth­ers, have ex­plored or in­vest­ed in CD3 ther­a­pies.

Two oth­ers are painkillers, both in Phase IIB. One is part of the wide-rang­ing search for a non-opi­oid painkiller and is an mPGES-1 in­hibitor. The oth­er is a TR­PA1 an­tag­o­nist that aims at neu­ro­path­ic pain, a no­to­ri­ous­ly dif­fi­cult tar­get.

“To the best of my knowl­edge there are no com­pa­nies that are as ad­vanced as we are,” Ri­va said of de­vel­op­ing a neu­ro­path­ic painkiller. “This is kind of dif­fi­cult.”

Al­so in Phase IIB is their OX40 an­tag­o­nist for au­to-im­mune dis­or­ders, cur­rent­ly be­ing test­ed on atopic der­mati­tis. OX40’s cen­tral role on T cells has made them a pop­u­lar tar­get for both can­cer and au­toim­mune treat­ments.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

via Shutterstock

Ex-biotech chief pleads guilty in col­lege ad­mis­sions scan­dal, faces a 10-month prison stretch in plea deal

The ex-CEO of Harmony Biosciences — as well as former board member for Biohaven — has agreed to plead guilty to two counts of mail fraud after getting caught up in the college admissions scandal.

Charged with paying Georgetown University’s former tennis coach more than $50,000 to get his daughter admitted to the university as a new recruit for the team, Bob Repella took the plea deal, which comes with a recommended sentence of 10 months in prison, with a year of supervised release and a $40,000 fine.

Al­ny­lam nabs speedy re­view, set­ting up 3rd pos­si­ble ap­proval in 3 years

After nearly two decades in the haze of preclinical and clinical development, things seem to be coming into focus for Alnylam Pharmaceuticals.

Two years ago the company landed the first approved drug for RNA interference (RNAi), a Nobel Prize-winning technique discovered in plants and pioneered around the turn of the century. Then last year, they landed another approval. Now, fresh off a massive investment from Blackstone, they’ve received an FDA priority review designation for a third therapy, setting them up to potentially nab three different approvals in three consecutive years.

Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

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