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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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