Ab­b­Vie preps fran­chise de­ci­sion af­ter Abl­ynx’s IL-6 drug goes head-to-head against Actem­ra

Ab­b­Vie was will­ing to bet up to $840 mil­lion that Abl­ynx’s nanobody tech could help it pro­tect and ex­pand its $14 bil­lion megafran­chise for Hu­mi­ra. To­day, Ab­b­Vie $AB­BV is get­ting a look at new Phase IIb da­ta for their part­nered IL-6 drug vo­bar­il­izum­ab (ALX-0061) that mea­sures up against Roche’s Actem­ra as it moves clos­er to its de­ci­sion on whether or not it will take it in­to Phase III.

But there’s no clear cut win here. In fact, on key ef­fi­ca­cy mea­sures, a low­er dose failed to mea­sure up to Actem­ra.

A high dose of vo­bar­il­izum­ab pro­vid­ed every two weeks did just man­age to edge out Actem­ra in two out of three stan­dard ef­fi­ca­cy mea­sures, though not by a sig­nif­i­cant amount. But Abl­ynx $ABLX al­so high­light­ed an edge on safe­ty da­ta and dropouts among the pa­tients with mod­er­ate to se­vere rheuma­toid arthri­tis that is re­sis­tant to methotrex­ate. And there’s ev­i­dence of low­er dis­ease ac­tiv­i­ty and an eas­i­er treat­ment reg­i­men to con­sid­er as well, with the most ef­fec­tive high dose pro­vid­ed every two weeks com­pared to Actem­ra’s week­ly sched­ule.

“We’re get­ting re­al­ly stand-out da­ta, which is great, and it is the first step for us in pro­vid­ing a da­ta pack­age to Ab­b­Vie, who will de­cide lat­er in the year whether to take up their op­tion and li­cense the prod­uct,” Abl­ynx CEO Ed­win Moses told Reuters in an in­ter­view. And Moses claims the drug has block­buster po­ten­tial.

But is that go­ing to fly with Ab­b­Vie?

When Ab­b­Vie struck the deal with Abl­ynx in 2013, they were look­ing to see if an IL-6 an­ti­body could pro­vide an al­ter­na­tive to Hu­mi­ra when pa­tients gen­er­at­ed an­ti­bod­ies against their an­ti-TNF drug. But now Ab­b­Vie is fight­ing against a host of biosim­i­lar man­u­fac­tur­ers look­ing to mus­cle in on their big U.S. fran­chise. And in this mar­ket­ing en­vi­ron­ment, any­thing that doesn’t mea­sure up as a big gain for pa­tients can be hard to sell.

There’s al­so a pre­ferred late-stage pro­gram at Ab­b­Vie to con­sid­er. Last fall, Ab­b­Vie axed a col­lab­o­ra­tion it has in place with Gala­pa­gos for their JAK1 in­hibitor fil­go­tinib (GLP0634), say­ing it pre­ferred to take their in-house pro­gram for ABT-494 in­to Phase III for arthri­tis.

“We be­lieve ABT-494 has the po­ten­tial to be­come a best-in-class ther­a­py, par­tic­u­lar­ly in the most chal­leng­ing pa­tient pop­u­la­tion of TNF-in­ad­e­quate re­spon­ders,” Ab­b­Vie CSO Michael Sev­eri­no not­ed af­ter the Phase II da­ta came out in Sep­tem­ber. The Phase III start­ed in Jan­u­ary.

Abl­ynx still has da­ta on a methotrex­ate com­bi­na­tion com­ing up in a mat­ter of weeks.

Ab­b­Vie has shown no re­luc­tance from walk­ing away from any part­nered pro­gram that doesn’t mea­sure up to ex­pec­ta­tions. Ab­b­Vie proved that when it re­cent­ly dropped its col­lab­o­ra­tion with In­fin­i­ty Phar­ma­ceu­ti­cals af­ter their blood can­cer drug du­velis­ib post­ed pos­i­tive but rel­a­tive­ly weak da­ta on in­do­lent non-Hodgkin dis­ease.

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.