Leo Phar­ma of­floads a pso­ri­a­sis as­set as their Dupix­ent ri­val heads to the FDA

Leo Phar­ma, a small, cen­tu­ry-old Dan­ish drug­mak­er, has spent the past few years tail­ing Sanofi on their fran­chise drug Dupix­ent, bet­ting that an an­ti­body they li­censed from As­traZeneca cou­pled with a few decades of ex­per­tise in der­ma­tol­ogy could com­pete with one of Big Phar­ma’s biggest drugs. They got a huge boost in that re­gard in De­cem­ber, with pos­i­tive Phase III re­sults in atopic der­mati­tis, and last week, when they an­nounced the FDA had ac­cept­ed their BLA for the drug.

Un­der the di­rec­tion of Thomas Hultsch, a for­mer Sanofi ex­ec who now runs trans­la­tion­al med­i­cine for Leo, the com­pa­ny has been de­vel­op­ing a suite of oth­er ex­per­i­men­tal der­ma­tol­ogy drugs. Now, though, with new part­ner­ships in the mix, they’re of­fload­ing their sec­ond most de­vel­oped com­pound to an­oth­er com­pa­ny.

In an up-to $200 mil­lion deal, Leo has agreed to give glob­al rights to their pso­ri­a­sis and atopic der­mati­tis can­di­date LP0058 to fel­low Dan­ish drug­mak­er Union Ther­a­peu­tics. Leo will al­so re­ceive sin­gle-dig­it roy­al­ties.

LP0058, now re­named UNI500, is an oral PDE4 in­hibitor. That’s a class of drugs that has long been used to treat skin con­di­tions, among oth­er in­flam­ma­to­ry con­di­tions. Most no­tably Ote­zla, the Cel­gene pso­ri­a­sis drug that Bris­tol My­ers Squibb sold off to Am­gen for $13.4 bil­lion last year af­ter the two com­pa­nies merged, is a PDE4 in­hibitor.

Leo can be cir­cum­spect when it comes to tri­al re­sults — the com­pa­ny didn’t an­nounce Phase III re­sults for the Dupix­ent ri­val for about a year af­ter the da­ta were com­plete — and they’ve yet to dis­close the re­sults of Phase II tri­als on the PDE4 in­hibitor. But the com­pa­ny said in a press re­lease that it had “demon­strat­ed su­pe­ri­or ef­fect over place­bo in ran­dom­ized, dou­ble-blind­ed, place­bo-con­trolled clin­i­cal stud­ies.”

For Leo, the out-li­cens­ing deal comes as the com­pa­ny is fo­cus­ing on com­mer­cial­iza­tion for its lead drug and new part­ner­ships that have shored up much of its ear­li­er pipeline with new­er ap­proach­es. In April, the com­pa­ny agreed to an up-to $570 mil­lion deal with One­ness Biotech in Tai­wan and Mi­cro­bio Shang­hai in Chi­na for FB825, a new drug that tries to tack­le eczema and asth­ma by de­plet­ing a kind of B cell called IgE. It’s a sim­i­lar ap­proach to the Roche and No­var­tis drug Xo­lair, which is al­ready ap­proved for asth­ma and now be­ing test­ed for atopic der­mati­tis.

So­cial/tile: News Øre­sund – Jo­han Wess­man (Flickr, Cre­ative Com­mons)

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.