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)

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Roche and Genen­tech re­searchers plot $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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