Al­ler­gan’s $560M buy­out deal just led to a PhI­II de­ba­cle as an­oth­er de­pres­sion drug goes down to bit­ter de­feat

Al­ler­gan’s $560 mil­lion deal to buy Nau­rex has led it straight down a blind al­ley for de­pres­sion drugs, where it’s been mugged by a de­ci­sive set of failed late-stage da­ta.

Brent Saun­ders’ biotech $AGN an­nounced af­ter the mar­ket closed that ra­pastinel had flunked the big set of Phase III stud­ies used to test the drug for ma­jor de­pres­sion. Topline re­sults from 3 Phase III tri­als along with a late-stage test on re­laps­es proved con­clu­sive­ly that the drug had none of its in­tend­ed ef­fects — ei­ther on the pri­ma­ry or sec­ondary end­points.

While de­pres­sion has proved one of the tough­est fields in bio­phar­ma, re­cent­ly de­feat­ing Alk­er­mes $ALKS in its own late-stage show­down, this marks a par­tic­u­lar­ly bit­ter pas­sage for Al­ler­gan, which has had a year full of set­backs that has blown up its share price and blis­tered the CEO as its crit­ics gained force.

David Nichol­son, Al­ler­gan

Al­ler­gan R&D chief David Nichol­son said he was “deeply dis­ap­point­ed” and added: “We will eval­u­ate the im­pact of these da­ta on the on­go­ing monother­a­py MDD pro­gram and sui­ci­dal­i­ty in MDD study. We ex­pect to make a de­ci­sion on these pro­grams dur­ing the course of 2019.”

It’s not look­ing good. Al­ler­gan’s shares were trad­ing near their high of $331 when they bought Nau­rex. Its shares slid 4% to $132 af­ter the bell rang and the news hit.

Nau­rex ex­ecs had built up hopes for this NM­DA drug, as­sert­ing its be­lief that it had found just the right way to mod­u­late the tar­get af­ter years of tri­al and er­ror. They lat­er spun out Aptinyx $AP­TX fol­low­ing the deal, then marked their own fail­ure weeks ago, which crip­pled its stock.

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.

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:”.

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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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.

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.

UP­DAT­ED: GSK adds to its trove of pos­i­tive da­ta for mul­ti­ple myelo­ma con­tender as ri­vals con­tin­ue to com­mand the spot­light

GlaxoSmithKline’s cancer R&D team put up more positive numbers for its ADC belantamab mafodotin, one of its top pipeline prospects.

Flashing the results just ahead of a busy ASCO weekend, Axel Hoos and the team noted new multiple myeloma data highlighting promising responses from their open-label DREAMM-6 study — after confirming the overall response rate of 32% among heavily pre-treated patients reviewed in DREAMM-2.

UP­DAT­ED: Dupix­ent clears PhI­II tri­al in new dis­ease as block­buster looks to ex­pand past Re­gen­eron-Sanofi split

Sanofi and Regeneron may be splitting up, but their billion-dollar baby, Dupixent, keeps on growing.

Already grossing over $2 billion last year based on FDA approvals for asthma and atopic dermatitis and a form of rhinosinusitis, Dupixent may be nearing a fourth indication: Eosinophilic esophagitis (EoE), an inflammatory disease marked by the buildup of white blood cells in the esophagus and which affects around 160,000 US patients annually.