FDA slams J&J’s block­buster con­tender sirukum­ab on ‘im­por­tant safe­ty risks’

Just days af­ter Glax­o­SmithK­line dumped its part­ner­ship with J&J on the late-stage rheuma­toid arthri­tis drug sirukum­ab, the FDA helped il­lus­trate why the phar­ma gi­ant was ready to bail at this late date.

In an in­ter­nal re­view out two days ahead of a sched­uled pan­el re­view, reg­u­la­tors spot­light­ed a trou­bling round of safe­ty da­ta for the IL-6 drug, which has pro­vid­ed on­ly mixed ef­fi­ca­cy re­sults so far. Ac­cord­ing to the re­view, there was a clear im­bal­ance in deaths and ma­lig­nan­cies among the pa­tients stud­ied over a 52-week pe­ri­od.

From the re­view:

Wide con­fi­dence in­ter­vals around treat­ment com­par­isons for se­ri­ous rare events such as death, ma­lig­nan­cy, and MACE in­di­cate that the im­bal­ances could be due to chance but al­so that rel­a­tive­ly large in­creas­es in risks on sirukum­ab can­not be ruled out based on the da­ta alone. Such im­bal­ances raise con­cern re­gard­ing these im­por­tant safe­ty risks. Ad­di­tion­al safe­ty sig­nals re­lat­ed to events of GI per­fo­ra­tion and hy­per­sen­si­tiv­i­ty were al­so ob­served.

Omi­nous­ly, the re­view al­so high­lights al­ter­na­tive RA ther­a­pies, rais­ing ad­di­tion­al ques­tions why the agency would green-light a drug with po­ten­tial safe­ty is­sues for a huge mar­ket.

High­light­ing the agency’s stance on rheuma­toid arthri­tis drugs, Eli Lil­ly re­vealed last week that the FDA had re­ject­ed its big block­buster con­tender baric­i­tinib af­ter a hand­ful of blood clots were seen in the drug arms of the com­par­a­tive stud­ies done.

In the mean­time, Re­gen­eron and Sanofi have strut­ted ahead to win a de­layed OK on sar­ilum­ab while Ab­b­Vie works on its own suc­ces­sor to Hu­mi­ra, ABT-494. And Gilead is mov­ing con­fi­dent­ly ahead with a mas­sive Phase III pro­gram for fil­go­tinib.

J&J, though, isn’t about to give up at this point. In a state­ment, the com­pa­ny said:

Pa­tient well-be­ing is our high­est pri­or­i­ty at Janssen and we take the safe­ty of all pa­tients par­tic­i­pat­ing in our clin­i­cal pro­grams very se­ri­ous­ly.  We rec­og­nize the com­plex­i­ty and se­ri­ous­ness of a dis­ease like rheuma­toid arthri­tis (RA) and the tremen­dous needs that re­main for new treat­ment al­ter­na­tives as pa­tients liv­ing with RA of­ten cy­cle through mul­ti­ple ther­a­pies un­til find­ing one that may work for them.  We are con­fi­dent in the ben­e­fit-to-risk of sirukum­ab and look for­ward to meet­ing with the Arthri­tis Ad­vi­so­ry Com­mit­tee to re­view ef­fi­ca­cy and safe­ty da­ta sup­port­ing the pro­posed in­di­ca­tion for the treat­ment of mod­er­ate­ly to se­vere­ly ac­tive RA.

We’ll find out more at the pan­el re­view on Wednes­day.

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. 

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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.