Go­ing deep­er in­to the ezce­ma game, No­var­tis or­ches­trates $1.1B deal for a Mor­phoSys/Gala­pa­gos drug

A busy busi­ness de­vel­op­ment team at No­var­tis has made der­ma­tol­ogy the fo­cus of their lat­est bil­lion-dol­lar deal.

The cho­sen drug is MOR106, an IL-17C mon­o­clon­al an­ti­body de­vel­oped by the part­ner­ship be­tween Mor­phoSys $MOR and Gala­pa­gos $GLPG. In ex­change for giv­ing up all de­vel­op­ment and mar­ket­ing rights, the duo will be split­ting $111 mil­lion (€95 mil­lion) up­front and pen­cil­ing in po­ten­tial mile­stone pay­ments to­tal­ing $1 bil­lion (€850 mil­lion).

This will be the sec­ond atopic der­mati­tis drug in No­var­tis’ pipeline, adding to ZPL389, the Phase II ezce­ma treat­ment it ac­quired in the Ziar­co buy­out late 2016.

Si­mon Mo­roney

With No­var­tis $NVS pick­ing up the tab for all fu­ture R&D, man­u­fac­tur­ing and com­mer­cial­iza­tion costs, Mor­phoSys and Gala­pa­gos will re­main in­volved in both the on­go­ing ear­ly-stage tri­als and any fu­ture tri­als to sup­port de­vel­op­ment of MOR106 in this in­di­ca­tion.

The atopic der­mati­tis are­na, of course, is not short of big phar­ma ri­vals look­ing to score their own block­busters, from Pfiz­er’s Eu­crisa to Re­gen­eron and Sanofi’s Dupix­ent, the lat­ter of which has been billed as a $5 bil­lion op­por­tu­ni­ty.

While No­var­tis is trust­ing the biotechs with the de­vel­op­ment work on that end, it’s go­ing to ex­plore ad­di­tion­al in­di­ca­tions for it­self as well. If that all works out, the roy­al­ties will range from low-teens to low-twen­ties.

“This col­lab­o­ra­tion with No­var­tis will en­able us to ac­cel­er­ate and broad­en the de­vel­op­ment of MOR106 be­yond our cur­rent fo­cus on atopic der­mati­tis and to ex­ploit the po­ten­tial of MOR106 to the max­i­mum. Da­ta from pre­clin­i­cal mod­els and ex­pres­sion analy­ses sug­gest that the tar­get of MOR106 might be in­volved in oth­er dis­eases, which jus­ti­fies ex­pand­ing the de­vel­op­ment pro­gram,” said Mor­phoSys CEO Si­mon Mo­roney in a state­ment.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.