GSK launch­es PhI­II lu­pus com­bo study with Benlysta/rit­ux­imab; Ci­pher snatch­es Cana­di­an drug port­fo­lio from Car­diome

→ GSK says it’s launch­ing a Phase III com­bo study to see how its lu­pus drug Benlysta (be­li­mum­ab) will work when com­bined with rit­ux­imab. The mon­o­clon­al an­ti­body rit­ux­imab has his­tor­i­cal­ly been used to treat can­cers like leukemia and lym­phomas, but al­so has been ef­fec­tive fight­ing rheuma­toid arthri­tis. GSK hopes com­bin­ing Benlysta (the on­ly bi­o­log­ic ap­proved to treat lu­pus) with rit­ux­imab will push lu­pus in­to re­mis­sion. “Be­li­mum­ab has al­ready demon­strat­ed its con­sis­tent ef­fi­ca­cy in re­duc­ing dis­ease ac­tiv­i­ty for pa­tients with SLE, with four suc­cess­ful Phase III tri­als,” Gi­js van den Brink, GSK’s glob­al head for im­muno-in­flam­ma­tion R&D, said in a state­ment. “The un­der­ly­ing bi­ol­o­gy of the dis­ease, com­bined with the re­sults from a small in­ves­ti­ga­tor-spon­sored study in se­vere re­frac­to­ry SLE (lu­pus), pro­vide a strong sci­en­tif­ic ra­tio­nale for ini­ti­at­ing this study. Our aim with this study is to as­sess whether the com­bi­na­tion treat­ment will not on­ly achieve a state of low dis­ease ac­tiv­i­ty, but po­ten­tial­ly al­so achieve clin­i­cal re­mis­sion in pa­tients liv­ing with this chron­ic and un­pre­dictable dis­ease.”

→ Van­cou­ver’s Car­diome Phar­ma Corp is sell­ing its Cana­di­an busi­ness port­fo­lio to On­tario’s se­r­i­al ac­quir­er Ci­pher Phar­ma­ceu­ti­cals for $25.5 mil­lion CAD ($19.5 mil­lion USD). The deal gets Ci­pher com­mer­cial and pipeline hos­pi­tal prod­ucts, in­clud­ing Brinavess (ver­nakalant IV), Ag­gra­s­tat (tirofiban hy­drochlo­ride), Xy­dal­ba (dal­ba­vancin hy­drochlo­ride), and Trevyent (a drug de­vice com­bo that de­liv­ers tre­pros­tinil). Brinavess and Ag­gra­s­tat are cur­rent­ly on the mar­ket in Cana­da.  Xy­dal­ba, which is ap­proved and mar­ket­ed by Al­ler­gan in the US as Dal­vance, could get ap­proval in Cana­da as ear­ly as the end of 2018.  A Cana­di­an reg­u­la­to­ry fil­ing for Trevyent is planned in 2019, ac­cord­ing to a Ci­pher state­ment.

→ San Diego biotech On­coSec $ONCS put out a cu­ri­ous press re­lease Tues­day not­ing a cost-cut­ting mea­sure to sig­nif­i­cant­ly down­size its of­fice and lab space. The com­pa­ny said its es­sen­tial­ly rent­ed out its old – much larg­er – space to a third par­ty and leased a space less than half its for­mer size. On­coSec said the new sit­u­a­tion puts $65,000 back in its pock­et per month, and trades a “$14 mil­lion li­a­bil­i­ty with a $2 mil­lion li­a­bil­i­ty.” Al­though the com­pa­ny’s new space is about 22,000 square-feet small­er, On­coSec made no men­tion of a down­sized staff in its press re­lease. How­ev­er, a re­cent reg­u­la­to­ry form filed with the SEC note the com­pa­ny’s staff has in­deed slimmed down in re­cent years. Back in 2015, the com­pa­ny’s then-CEO Punit Dhillon said On­coSec em­ployed 55 peo­ple. As of Oc­to­ber 2017, that num­ber has dwin­dled to 35 em­ploy­ees. On­coSec’s lead pro­gram, Im­munoPulse IL-12, is in clin­i­cal de­vel­op­ment for metasta­t­ic melanoma and triple-neg­a­tive breast can­cer. The pro­gram is geared to­ward pa­tients with melanoma who are re­frac­to­ry or have re­lapsed on an­ti-PD-1 ther­a­pies.

→ An in­ter­na­tion­al group of in­vestors is be­hind Ox­ford Nanopore’s lat­est £100 mil­lion ($140 mil­lion) round to dri­ve its DNA/RNA se­quenc­ing tech­nol­o­gy, in­clud­ing Chi­na Con­struc­tion Bank In­ter­na­tion­al, Sin­ga­pore’s GIC and Aus­tralia’s Host­plus. The British firm — known for a portable re­al-time DNA/RNA se­quencer called Min­ION — aims to scale up its op­er­a­tions across R&D, man­u­fac­tur­ing and sales with the pro­ceeds. Two de­vices with big­ger ca­pa­bil­i­ties in an­i­mals, plants and the en­vi­ron­ment will join the cur­rent suite com­pris­ing Min­ION and its desk­top coun­ter­part Grid­ION. The mon­ey will al­so be in­vest­ed in a new man­u­fac­tur­ing fa­cil­i­ty, to be built on a sci­ence park south of Ox­ford, as well as the ex­pan­sion of the com­mer­cial team.

Zealand Phar­ma $ZEAL cel­e­brat­ed a step for­ward to­day with Phase III da­ta show­ing that dasiglucagon did not in­duce or boost an­ti-drug an­ti­bod­ies in pa­tients with type 1 di­a­betes. De­signed to eval­u­ate dasiglucagon in the treat­ment of se­vere hy­po­glycemia, or ex­treme­ly low blood sug­ar, the tri­al pits the drug against re­con­sti­tut­ed glucagon pow­der. Pre­vi­ous Phase II re­sults has sug­gest­ed that the res­cue pen-fit­ted glucagon ana­log boost­ed plas­ma glu­cose bet­ter than the ac­tive com­para­tor. The Copen­hagen-based biotech hopes it would hap­pen again in a sep­a­rate Phase III ef­fi­ca­cy tri­al, with re­sults ex­pect­ed in the sec­ond half of this year.

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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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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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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