J&J pitch­es its top 11 drugs in the pipeline — with a peak sales promise of $1B-plus

Joaquin Du­a­to at an End­points News event in San Fran­cis­co on Jan­u­ary 10, 2017


Over the last six years, J&J has nailed 11 new drug ap­provals. Look­ing for­ward over the next five years, the phar­ma gi­ant is fore­cast­ing that it can dou­ble that, with more than 10 new ap­provals for block­buster meds out of its late-stage pipeline. And it needs them all to keep up with an am­bi­tious growth fore­cast for its phar­ma di­vi­sion rev­enue.

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 are 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.

Bill Hait, glob­al head of R&D, said he ex­pects 14 new meds to ar­rive in next five years, with 50 line ex­ten­sions on al­ready ap­proved ther­a­pies.

Bill Hait

First up, the two new im­munol­o­gy drugs al­ready filed for ap­proval and well known to in­vestors: guselkum­ab for pso­ri­a­sis; and sirukum­ab for rheuma­toid arthri­tis.

The next nine po­ten­tial block­busters cov­er a range of core fo­cus­es, with a ma­jor con­cen­tra­tion on on­col­o­gy. They are:

  • Apa­lu­tamide (ARN-509) for pre-metasta­t­ic prostate can­cer. J&J picked up this drug with its $1 bil­lion deal for Aragon.
  • Es­ke­t­a­mine for treat­ment-re­sis­tant de­pres­sion. This is an in­tranasal ver­sion of ke­t­a­mine, a horse tran­quil­iz­er and well known par­ty drug (Spe­cial K) known for rapid on­set with a host of side ef­fects.
  • Ta­la­co­tuzum­ab (JNJ-56022473/CSL362) for acute myeloid leukemia. This drug, orig­i­nal­ly from CSL, us­es Xen­cor’s an­ti­body tech.
  • Erdafi­tinib (an FGFR In­hibitor) for sol­id tu­mors.
  • Ni­ra­parib for prostate can­cer. Al­ready ap­proved in the US ear­li­er this year as Ze­ju­la, J&J picked up com­mer­cial rights on this PARP in­hibitor in a $500 mil­lion deal.
  • Ime­tel­stat for myelofi­bro­sis. Geron re­vealed a few weeks ago that J&J’s re­view of the da­ta from two stud­ies of its drug ime­tel­stat war­rant­ed con­tin­ued work in myelodys­plas­tic syn­dromes and myelofi­bro­sis. But the phar­ma gi­ant $JNJ is still re­serv­ing the right to quit if the da­ta doesn’t hold up lat­er in the year. That’s not a big vote of con­fi­dence.
  • Pi­modi­vir (JNJ-3872) for in­fluen­za A. J&J picked up this one from Ver­tex in 2014. Not much has been heard about it since then.
  • Lu­mic­itabine (JNJ-1575) for res­pi­ra­to­ry syn­cy­tial virus (RSV) in­fec­tion. J&J got this in their $1.75 bil­lion buy­out of Alios in 2014, which al­so net­ted drugs for hep C — a mar­ket that is be­ing flat­tened by some very ef­fec­tive cures.
  • JNJ-7922 (orex­in-2 an­tag­o­nist) for ad­junc­tive treat­ment for ma­jor de­pres­sive dis­or­der. This is a new one on me.

Ge­off Meacham at Bar­clays gave J&J’s pre­sen­ta­tion to­day sol­id marks for the longterm, but he sees an up­hill strug­gle at the phar­ma gi­ant as it wres­tles with some dis­ap­point­ing rev­enue num­bers. His note:

JNJ’s in­creas­ing em­pha­sis on on­col­o­gy (Darza­lex, apa­lu­tamide, ni­ra­parib, ta­la­co­tuzum­ab for AML) is a pos­i­tive step, which should of­fer bet­ter pric­ing pro­tec­tion vs. oth­er ther­a­peu­tic cat­e­gories such as im­munol­o­gy (biosim­i­lars) and di­a­betes (SGLT-2s).  JNJ is tar­get­ing above-mar­ket growth over the next decade, which we think is like­ly achiev­able, but our sense is that in­vestor con­vic­tion is low in con­vert­ing the port­fo­lio from lega­cy as­sets to new launch­es (e.g. apa­lu­tamide for Zyti­ga, guselkum­ab/sirukum­ab for Rem­i­cade). In­deed, while there is like­ly a sus­tained pe­ri­od of ac­cel­er­a­tion of in­ter­nal­ly dri­ven, or­gan­ic growth in the in­ter­me­di­ate-to-longer term, the next 1-2 years may be tough with the pend­ing Acte­lion deal pro­vid­ing a fix but not one that is like­ly to dri­ve mul­ti­ple ex­pan­sion.

It’s im­por­tant to re­mem­ber that the suc­cess rate for Phase III drugs is about 50%, and pay­ers have been rad­i­cal­ly al­ter­ing the land­scape for new drug prices. That all presents J&J with some big po­ten­tial pit­falls along the way to achiev­ing its goals. But with a $7 bil­lion an­nu­al bud­get for R&D, Du­a­to and Hait want in­vestors to know what they can ex­pect for the mon­ey.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

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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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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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.