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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Pearl Huang, former Cygnal Therapeutics president and CEO

UP­DAT­ED: Flag­ship builds a new start­up out of pieces from 2 of its biotechs. And a Roche vet leaves to do some­thing new

Flagship has crafted a new startup out of pieces from a pair of fledglings in the VC’s nest. And a prominent Roche veteran who ran one of the biotechs won’t be making the next leg of the journey.

The new company is called Sonata Therapeutics, which is picking up the work that Inzen was doing related to the cellular microenvironment and combining with Flagship’s Cygnal Therapeutics, which came out of stealth more than 3 years ago and put Pearl Huang — the BeiGene founder and former Roche SVP — at the helm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.