J&J is jet­ti­son­ing two of its promised block­buster drugs, and it could­n't come at a worse time

Just 5 months af­ter try­ing to con­vince in­vestors that they were on to a large pipeline of block­busters head­ing to the mar­ket, J&J has al­ready de­cid­ed that two of them are es­sen­tial­ly worth­less, or just too dan­ger­ous to use.

Joaquin Du­a­to

The writ­ing was al­ready on the wall months ago for sirukum­ab, once a top prospect for rheuma­toid arthri­tis un­til its part­ners at Glax­o­SmithK­line sud­den­ly walked out. Ear­li­er this year, though, a pan­el of out­side ex­perts vot­ed down the mar­ket­ing ap­pli­ca­tion, fret­ting over an un­ex­plained im­bal­ance in deaths in the study. The in­evitable for­mal re­jec­tion fol­lowed.

The oth­er drug to get the ax to­day is com­plete­ly un­ex­pect­ed. It’s ta­la­co­tuzum­ab (JNJ-56022473/CSL362) for acute myeloid leukemia. This Phase III drug, orig­i­nal­ly from CSL, us­es Xen­cor’s an­ti­body tech.

What went wrong? A spokesper­son for J&J says the drug failed to live up to ex­pec­ta­tions in Phase III:

That de­ci­sion was based on a rec­om­men­da­tion by the In­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee as the Phase III re­sults did not demon­strate a pos­i­tive ben­e­fit/risk ra­tio.

J&J al­so of­fered a state­ment on sirukum­ab, not­ing that it’s dis­ap­point­ed by the need to kill it now.

We main­tain our be­lief in the ef­fi­ca­cy and safe­ty of sirukum­ab, an an­ti-IL-6 mon­o­clon­al an­ti­body.  How­ev­er, the need for ad­di­tion­al clin­i­cal da­ta would re­sult in sig­nif­i­cant de­lays to pa­tient ac­cess in parts of the world.  Giv­en this, as well as the avail­abil­i­ty of oth­er treat­ments tar­get­ing the IL-6 path­way, Janssen has made a strate­gic de­ci­sion to pri­or­i­tize oth­er as­sets in our port­fo­lio.

This is not the kind of news that J&J wants or needs right now. The phar­ma con­glom­er­ate has been strug­gling on the rev­enue side, leav­ing some promi­nent an­a­lysts won­der­ing if it can con­tin­ue to grow phar­ma sales.

In May, Joaquin Du­a­to, J&J’s world­wide chair­man for phar­ma­ceu­ti­cals, com­mit­ted to see­ing J&J’s brand­ed drug mar­ket main­tain a clip of 5% an­nu­al growth through 2020, de­spite some stiff “head­winds” on prices — “where price growth is flat­ten­ing” — with three ap­provals slat­ed for 2017 and four more which the phar­ma gi­ant ex­pects to ush­er in­to the mar­ket in 2018.

These new drugs were part of one leg of the com­pa­ny’s three-leg strat­e­gy for grow­ing rev­enue, with a promise that it can im­prove sig­nif­i­cant­ly on ex­ist­ing drugs — like Ste­lara, In­vokana and Xarel­to — while beef­ing up on a new core fo­cus on pul­monary ar­te­r­i­al hy­per­ten­sion through the Acte­lion buy­out.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.