Am­gen tees up a swift ap­proval for a fran­chise de­stroy­er aimed at Ab­b­Vie’s $14B drug Hu­mi­ra

The FDA wast­ed lit­tle time in com­ing to the point in their re­view of Am­gen’s ap­pli­ca­tion for ABP501, their new biosim­i­lar of Ab­b­Vie’s megablock­buster in­flam­ma­to­ry drug Hu­mi­ra: They got it right.

“In con­sid­er­ing the to­tal­i­ty of the ev­i­dence, the da­ta sub­mit­ted by Am­gen sup­port a demon­stra­tion that ABP 501 is high­ly sim­i­lar to US-li­censed Hu­mi­ra, notwith­stand­ing mi­nor dif­fer­ences in clin­i­cal­ly in­ac­tive com­po­nents, and sup­port a demon­stra­tion that there are no clin­i­cal­ly mean­ing­ful dif­fer­ences be­tween ABP 501 and US-li­censed Hu­mi­ra in terms of the safe­ty, pu­ri­ty, and po­ten­cy of the prod­uct to sup­port the demon­stra­tion that ABP 501 is biosim­i­lar to the US-li­censed Hu­mi­ra in the stud­ied in­di­ca­tions of RA and PsO,” the agency notes in their ex­ec­u­tive re­view.

And Am­gen should have a clean shot at all the in­di­ca­tions Hu­mi­ra – the dom­i­nant arthri­tis treat­ment on the mar­ket – is ap­proved for.

“The Ap­pli­cant has al­so pro­vid­ed an ex­ten­sive da­ta pack­age to ad­dress the sci­en­tif­ic con­sid­er­a­tions for ex­trap­o­la­tion of da­ta to sup­port biosim­i­lar­i­ty to oth­er con­di­tions of use and po­ten­tial li­cen­sure of ABP 501 for each of the in­di­ca­tions for which US-li­censed Hu­mi­ra is cur­rent­ly li­censed and for which Am­gen is seek­ing li­cen­sure.”

The re­view comes just ahead of a pan­el re­view for ABP 501 next week, the lat­est in a wave of ap­pli­ca­tions aimed at some of the biggest block­busters on the mar­ket.

No­var­tis CEO Joe Jimenez

Ab­b­Vie and Am­gen have been squared off in a fight over the huge Hu­mi­ra fran­chise, but it seems clear that copy­cat ver­sions of Hu­mi­ra are loom­ing that will slice and dice the mar­ket for the $14 bil­lion drug, which ac­counts for more than half of Ab­b­Vie’s rev­enue. Now that the FDA has es­tab­lished a clear path­way for ap­provals, a num­ber of big com­pa­nies have tar­get­ed Hu­mi­ra and oth­er ag­ing bi­o­log­ics.

Sur­veys of physi­cians are find­ing a ready will­ing­ness to adopt cheap­er copies of the orig­i­nal. And some com­pa­ny ex­ecs, like No­var­tis CEO Joe Jimenez, are pre­dict­ing that a round of ap­provals in each cat­e­go­ry could trig­ger dis­counts of up to 75%. That’s much deep­er than the ini­tial 25% to 30% dis­count fore­cast. And it bodes ill for Ab­b­Vie, which still re­lies pre­dom­i­nant­ly on Hu­mi­ra – though it has been wheel­ing and deal­ing on new drugs that can take its place.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.