With biosim­i­lars gain­ing mo­men­tum, Am­gen and Al­ler­gan cite suc­cess of Her­cept­in's copy­cat

Am­gen and Al­ler­gan are re­port­ing a new suc­cess for their part­ner­ship aimed at de­vel­op­ing a slate of four big biosim­i­lars. In­ves­ti­ga­tors re­port­ed that ABP 980 was vir­tu­al­ly in­dis­tin­guish­able from Roche’s $6.5 bil­lion fran­chise drug Her­ceptin (trastuzum­ab) in pa­tients with hu­man epi­der­mal growth fac­tor re­cep­tor 2-pos­i­tive (HER2-pos­i­tive) ear­ly breast can­cer in a Phase III tri­al.

The re­sults set up an­oth­er shot at a near-term ap­proval, fol­low­ing Am­gen’s so­lo suc­cess in front of an FDA pan­el re­view a week ago for its biosim­i­lar of Ab­b­Vie’s $14 bil­lion fran­chise drug Hu­mi­ra. A day lat­er Am­gen was play­ing de­fense, try­ing to slow No­var­tis’s ef­fort to win an ap­proval for a biosim­i­lar of En­brel, a $9 bil­lion gold mine for Am­gen and its part­ners.

There have been some set­backs in the field, in­clud­ing one ear­li­er this week when No­var­tis re­vealed that the FDA had is­sued a CRL for their biosim­i­lar of Neu­las­ta. But ev­i­dence has been mount­ing that a pi­o­neer­ing ap­proval last year has set the stage for a roll­out of a new wave of cheap­er gener­ic bi­o­log­ics over the next four years. The main im­ped­i­ment now: law­suits filed over patents and ap­pli­ca­tions, aimed at scut­tling the com­pe­ti­tion.

Am­gen alone has a slate of biosim­i­lars in the pipeline. Al­ler­gan al­so has its own pro­grams in the works as well.

Sean E. Harp­er, M.D., ex­ec­u­tive vice pres­i­dent of Re­search and De­vel­op­ment at Am­gen, of­fered this in pre­pared text:

We be­lieve this study con­firms no clin­i­cal­ly mean­ing­ful dif­fer­ences be­tween ABP 980 and trastuzum­ab, and we look for­ward to con­tin­ued dis­cus­sions with reg­u­la­to­ry au­thor­i­ties. Biosim­i­lars are ap­proved based on the an­a­lyt­i­cal, non­clin­i­cal and clin­i­cal da­ta, and we be­lieve that the to­tal­i­ty of the ev­i­dence we’ve gen­er­at­ed sup­ports ABP 980 as high­ly sim­i­lar to the ref­er­ence prod­uct.

The part­ners al­so re­port­ed the suc­cess of their biosim­i­lar of Avastin in a Phase III last fall.

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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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Le­vo Ther­a­peu­tics miss­es pri­ma­ry end­point in PhI­II tri­al of Prad­er-Willi drug — the lat­est set­back in a dis­as­ter-prone field

Marking yet another setback in the Prader-Willi Syndrome field, Levo Therapeutics failed to hit its primary endpoint in a Phase III study of intranasal carbetocin. But the biotech is now shifting its focus to the secondary endpoints in an effort to pluck victory out of the jaws of defeat.

The disorder, characterized by a false sense of starvation, is caused by the absence or deletion of a father’s chromosome 15. Illinois-based Levo’s potential therapy involves a selective oxytocin-receptor agonist.

Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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